DOCUMENT
65 -- CORONARY STENT CONSIGNMENT AGREEMENT - Attachment
- Notice Date
- 8/18/2016
- Notice Type
- Attachment
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 2;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904
- ZIP Code
- 10468-3904
- Solicitation Number
- VA24216N0931
- Response Due
- 8/29/2016
- Archive Date
- 10/28/2016
- Point of Contact
- Donna Richardson
- E-Mail Address
-
Richardson4@va.gov<br
- Small Business Set-Aside
- Service-Disabled Veteran-Owned Small Business
- Description
- ****Request for information only**** Response date (Deadline): NOON on Monday August 29, 2016 Contract Specialist: Donna Richardson at Donna.Richardson4@va.gov: CORONARY STENTS CONSIGNMENT AGREEMENT FOR VISN2 This request for information (RFI) is posted for market research purposes ONLY. It is not a solicitation. The Department of Veterans Affairs New York Healthcare System Veterans Integrated Service Network (VISN2) is seeking Contractors that can supply consignment inventory of Coronary Stents for Prosthetics and Sensory Aids services at the Department of Veterans Affairs Medical Center (VAMC). The consignment inventory of Coronary Stents must consist of a drug eluting and its corresponding bare metal stent in various sizes, lengths, and diameters for VA Cardiology attending physicians providing medical care at the New York Harbor Healthcare System Manhattan Campus (NYHHS-MC) located at 423 east 23rd Street, NY, NY 10010. VISN2 intends to award a multi-award Consignment Agreement to Service Disabled Veteran Owned Small Business/ Veterans Owned Small Business to fulfill this requirement. SPECIFICATIONS Any subsequent solicitation will include (but is not limited to) the following requirements: 1..The base period for this consignment agreement will be for one year, with four unilateral one-year option periods that may be exercised by the NYHHS- MC. The effective date of the consignment shall be 30 days (or sooner upon mutual agreement) after the date of award. 2..The Contractor will coordinate with medical center Point of Contacts (POC's) and have the requested items stocked at the medical facility. Delivery of products shall be made to the NYHHS-MC at no cost to the Government. 3.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 4. The term "Products" as used herein shall mean all medical devices (coronary stents), which are owned by THE CONTRACTOR but located on Customer's premises (or within customer's control). NYHHS-MC is responsible for storing the product to use as indicated by the product's labeling. Once used, NYHHS-MC orders a replacement, and is invoiced at the agreed upon price for the replacement product. 5.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. 6.The contractor 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 NYHHS-MC 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 stents delivered to VAMC's shall be accompanied by a complete inventory listing to include lot numbers and expiration dates. 7.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. 8.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. 9. 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 NYHHS-MC staff. NYHHS-MC will provide adequate space/shelving for the consignment. 10.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. 11.Customer shall order replenishment product(s) through Contractor's Customer Service Department or designated Contractor Representative by providing a purchase/delivery order number. 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. 12.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 month) conduct a physical inventory of the consignment inventory with the contractor representative, and the results shall be detailed in a report to the COR. 13.Contractor will remove or replace inventory as necessary. NYHHS-MC may request that inventory having less than 60 days sterility/expiration date be removed and replaced within 48 hours of notification by NYHHS-MC. 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. 14. 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 NYHHS-MC. 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. 15.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. 16. 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. 17.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. 18.The Contractor agrees that it shall establish and maintain a separate account for all products pursuant to this Agreement. 19. Contractor shall evaluate NYHHS-MC actual usage and purchase volumes vs. the expected volume noted on this agreement on a quarterly basis and review the results with NYHHS-MC representative. After such review the Contractor reserves the right to request return of any unused products. 20. 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. 21.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. 22.Contractor shall provide on-site, in-service training to VA personnel that is 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. 23.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. 24.The Contractor shall immediately notify NYHHS-MC and contracting activities 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. 25.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. 26.The contractor will provide to the contracting officer the following information: A list of specific awarded items which shall be updated. 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. 26.1.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. 26.2.The Contractor is a NYHHS-MC contractor and will assist in the provision of health care to patients seeking such care from or through NYHHS-MC. As such, the Contractor is considered as being part of the Department Health Care activity. The contractor is considered to be a NYHHS-MC contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of NYHHS-MC records access and patient confidentiality, Contractor is considered to be a NYHHS-MC contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of NYHHS-MC, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of NYHHS-MC records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from NYHHS-MC has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as NYHHS-MC. The records referred to above shall be and remain the property of NYHHS-MC and shall not be removed or transferred from NYHHS-MC except in accordance with U.S.C. 552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to NYHHS-MC's records, at NYHHS-MC's place of business on request during normal business hours, to inspect and review and make copies of such records. All interested parties should provide the following information via e-mail to the contracting officer and/or through EBuy: 1.Comprehensive information about the relevant products and services offered on the company's schedule contract. 2.Corresponding FSS Contract number. 3.A sample of an existing consignment agreement between your company and either a VA or private sector healthcare facility. 4.Company Point of Contact information For planning and scheduling purposes, to insure being included in our market research for this product, responses must be received no later than NOON Response date (Deadline): Monday, August 29, 2016 All questions should be directed to the Contract Specialist, (by email only) at Donna.Richardson4@va.gov [No Phone Call Please] Time permitting, responses received after that date may be included in our research but cannot be guaranteed. Contracting Office Address: VISN 2 Network Contracting Office (NCO2) James J. Peters VA Medical Center 130 West Kingsbridge Road, Bronx, New York 10468-3992 Point of Contact(s): Donna Richardson, Contract Specialist Medical Sharing/Healthcare Acquisitions VHA Network Contracting Office 2 E-mail: Donna.Richardson4@va.gov Disclaimer This "Sources Sought" Request for Information (RFI) notice is issued solely for information and planning purposes only and does not constitute a solicitation. 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.
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- Document(s)
- Attachment
- File Name: VA242-16-N-0931 VA242-16-N-0931.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2953273&FileName=VA242-16-N-0931-000.docx)
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- File Name: VA242-16-N-0931 VA242-16-N-0931.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2953273&FileName=VA242-16-N-0931-000.docx)
- Record
- SN04229863-W 20160820/160818235212-de47e523d3cf59e78b9a928ad7d9e024 (fbodaily.com)
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