SOURCES SOUGHT
65 -- Covera Vascular Covered Stents Consignment Agreement
- Notice Date
- 8/4/2023 2:01:10 PM
- Notice Type
- Sources Sought
- Contracting Office
- 256-NETWORK CONTRACT OFFICE 16 (36C256) RIDGELAND MS 39157 USA
- ZIP Code
- 39157
- Solicitation Number
- 36C25623Q1597
- Response Due
- 8/11/2023 2:00:00 PM
- Archive Date
- 08/21/2023
- Point of Contact
- Marcos Madrazo-Jones, Contracting Officer, Phone: (713) 791-1414 ext. 22136
- E-Mail Address
-
marcos.madrazo-jones@va.gov
(marcos.madrazo-jones@va.gov)
- Awardee
- null
- Description
- This is a sources sought announcement only and not a request for quotes, bids, or proposals. This request is solely for the purpose of conducting market research to enhance the Department of Veterans Affairs (VA), Network Contracting Office 16 (NCO 16) understanding of the market offered products, services, and capabilities. Your responses to the sources sought will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The VA, NCO 16 is seeking to identify potential qualified vendors interested in a consignment agreement to provide various Covera Vascular Covered Stents. The base period for this consignment agreement will be for one year with four unilateral one-year option periods. This requirement is for the Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Boulevard, Houston, Texas 77030. Reference the Statement of Work (SOW) for additional details. The North American Industry Classification Code (NAICS) is 339112, Surgical and Medical Instrument Manufacturing with a size standard of 1000 employees. Prior to issuing a solicitation, and pursuant to the Veterans First Contracting Program, the VA is trying to ascertain if there are any qualified Service Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Businesses (VOSB) with the capability of fulfilling the requirement: (Respondents are not limited to SDVOSB/VOSB concerns; the Government seeks to identify all potentially interested sources). All responsible vendors and interested parties please respond to this sources sought announcement if you can fulfill the requirements described in the SOW. Responses to this sources sought shall include the following information: 1. Your company name, address, contact person name, phone number, fax number, e-mail address(s), UEI number, number of employees, and company website if available. 2. If you are an GSA/FSS contract holder are the referenced items available on your schedule/contract? Provide your company GSA/FSS contract number and contract expiration date, if applicable. 3. Is your company a contract holder on any other federal contract? Are the referenced items available for purchase on this federal contract? If so, please provide the contract number. 4. Socio-economic status of business such as but not limited to (SDVOSB/VOSB, 8(a), HUB Zone, Women Owned Small Business, Small disadvantaged business, or Small Business HUB Zone business, Large Business, etc.). 5. Is your company considered small under the NAICS code identified in this sources sought announcement? 6. Is your company the manufacturer, distributor, or an equivalent for the products being offered? If an authorized distributor or equivalent, can you provide documentation from the manufacturer confirming authorization to provide the referenced items and/or products being offered? If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule in accordance with Title 13 CFR 121.406(b) Nonmanufacturers. Does your company exceed 500 employees? Is your company primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied? Does your company take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; and Will supply the end item of a small business manufacturer, processor or producer made in the United States, or obtains a waiver of such requirement pursuant to Title 13 CFR 121.406 paragraph (b)(5). 7. If your company is a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of contact and size status (if available). 8. What is the manufacturing country of origin of the items and/or products being offered? 9. Vendors are requested to submit estimated market research pricing with their responses. The estimated pricing will be considered when determining the procurement strategy for the future solicitation. (e.g., if Contracting Officer determines that capable small businesses cannot provide fair and reasonable pricing, then the solicitation will not be set-aside). The estimated market research pricing will not be used to evaluate for any type of award. Interested vendors are reminded that in accordance with FAR subpart 4.12, offerors and quoters are required to complete electronic annual representations and certifications in System for Award Management (SAM) accessed via https://www.sam.gov as a part of required registration (see FAR 4.1102 - Policy). All registrants are required to review and update the representations and certifications submitted to SAM as necessary, but at least annually, to ensure they are kept current, accurate, and complete. The representations and certifications are effective until one year from date of submission or update to SAM. This notice shall not be construed as a commitment by the Government to ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. All information submitted in response to this sources sought notice will become property of the Government. Interested vendors should submit an email to marcos.madrazo-jones@va.gov. All responses must be received in writing no later than 4:00 PM CST on August 11, 2023. Questions or inquiries will not be answered or acknowledged, and no feedback or evaluations will be provided. No solicitation document is available at this time. This notice is to acquire information only, therefore your response will not be considered for a contract award. Vendors interested in providing an offer will have to respond to a solicitation announcement that shall be published separately. (The remainder of this page is intentionally blank) STATEMENT OF WORK (SOW) CONSIGNMENT AGREEMENT SCOPE: The Department of Veterans Affairs (VA), Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Boulevard, Houston, Texas 77030 intends to procure various Covera Vascular Covered Stents under a consignment agreement for a base period of one year with four unilateral one-year option periods. Consignment agreements must only be established under a contract and by a Contracting Officer (CO). A consignment agreement is a delivery method for a specified period of time in which the contractor provides items for Government use and the Contractor receives reimbursement only if and when the item is used by the Government. Unused items are returned to the contractor at the end of the effective period of the agreement without reimbursement or other expenses to the Government. REQUIREMENTS: MEDVAMC Interventional Radiology requires Covera Vascular Covered Stents for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an Arterio-Venous (AV) fistula and at the venous anastomosis of an expanded polytetrafluoroethylene (ePTFE) or other synthetic AV graft. These stents keep grafts and fistulas open, allowing patients to continue dialysis treatments. PRODUCT CHANGES/MODIFICATIONS: It is understood that there are continual changes in the field of interventional radiology, and new and improved products are released to the marketplace every year. Therefore, the awarded contract may be modified, through mutual agreement of the parties, to include new vascular covered stents. Pursuant to Federal Acquisition Regulation (FAR) 43.102, no government personnel other than the CO can execute contract modifications on behalf of the Government. The Contractor shall communicate with the Contracting Officer Representative (COR) on all matters pertaining to contract administration and technical direction. Only the CO is authorized to make commitments or issue changes that shall affect price, quantity, or quality of performance of this contract. All unauthorized inventory, regardless of amount, will be handled through the ratification process. CONSIGNMENT TERMS: GENERAL: The Contractor shall furnish and maintain an inventory of stents as required. The Contractor shall coordinate with the COR to have the requested items stocked at the medical facility. The products shall be placed in the MEDVAMC Radiology Department on a consignment basis in accordance with the terms and conditions of this agreement. The Government will be responsible for proper storage and security for all items supplied. Delivery of products shall be made to MEDVAMC, 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 which are owned by THE CONTRACTOR but located on Customer s premises (or within customer s control). MEDVAMC is responsible for storing the product to use as indicated by the product s labeling. Once a product is used, MEDVAMC orders a replacement and is invoiced at the agreed upon price. NOTE: MEDVAMC will have the responsibility for determining the product(s) that will be utilized from the entire product line. If MEDVAMC determines that a patient s circumstance warrants use of a product that is unavailable from the Contractor product line, MEDVAMC 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 fifteen (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, 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 COR responsible for the consignment agreement. The Contractor shall provide an efficient delivery system for the use of a Consignment Agreement . After award, the MEDVAMC will inform the Contractor of the chosen method of delivery. Normal delivery will be within forty-eight (48) hours. 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 contractor shall replace, at no additional charge, any item(s) that is 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. INVENTORY LEVEL: Initial consignment inventory shall be delivered to MEDVAMC within fifteen (15) calendar days after receipt of the fully executed agreement at no expense to the Government. Products listed below in section 4.c Stock Level Agreement represent the stents that shall be available for the initial inventory. MEDVAMC will provide adequate space/shelving for the consignment items. Delivery tickets. All shipments made under this agreement shall be accompanied by a delivery ticket. At minimum, delivery tickets will include the following: Name and Address of Supplier Name and Address of Receiver Product Number, Product Description, and Quantity Shipped Serial numbers and or expiration date if applicable Customer PO number and Sales Order number At no time shall the number of products MEDVAMC 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 forty-eight (48) hours at no additional expense to the Government. The inventory level may be increased based upon need and usage during the contract term with mutual agreement of the parties. The COR will verify and approve the Contractor s proposed consignment level as acceptable. A copy of the approved inventory stocking level will be forwarded to the CO for the contract modification. The Contractor shall not commence any changes until notified in writing by the CO. STOCK LEVEL AGREEMENT: Stock Level Agreement Part# Description Par Level AVSM07040 Vascular Covered Stent 2 AVSM07060 Vascular Covered Stent 2 AVSM07080 Vascular Covered Stent 2 AVSM08040 Vascular Covered Stent 2 AVSM08060 Vascular Covered Stent 2 AVSM08080 Vascular Covered Stent 2 AVSM09040 Vascular Covered Stent 2 AVSM09060 Vascular Covered Stent 2 AVSM09080 Vascular Covered Stent 2 AVSM10040 Vascular Covered Stent 2 AVSM10060 Vascular Covered Stent 2 AVSM10080 Vascular Covered Stent 2 AVFM07040 Vascular Covered Stent 2 AVFM07060 Vascular Covered Stent 2 AVFM08040 Vascular Covered Stent 2 AVFM08060 Vascular Covered Stent 2 AVFM09060 Vascular Covered Stent 2 AVFM09080 Vascular Covered Stent 2 AVFM10060 Vascular Covered Stent 2 AVFM10080 Vascular Covered Stent 2 MAINTENANCE OF INVENTORY: All consignment inventories will be coordinated with the COR. The designated COR periodically (no less than once per quarter) will conduct a physical inventory of the consignment inventory with the Contractor representative and the results shall be detailed in a report to the COR. The Contractor shall evaluate the actual usage and purchase volume versus the estimated usage and review the results with designated COR. Inventory levels may be adjusted accordingly. A copy of inventory list shall be provided to the COR by the Contractor after each physical inventory. In the event any such audit reveals that the actual inventory of consigned products is less than the levels set out in the current stock inventory, the COR will determine and communicate with the Contractor the best solution to get the inventory levels adjusted by either replacing stock, returning item(s) to the stock, or determining if stock has been used. The Contractor will maintain, remove, or replace inventory as necessary. The COR may request that inventory having less than 60 days sterility/expiration date be removed and replaced within forty-eight (48) hours of notification. A list of all products will be provided to the designated COR 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. OWNERSHIP AND LIABILITY: The ownership and title of all consigned items shall remain with the Contractor until item(s) are used by the Government. The Government assumes no ownership for any item(s) stored at the VA on a consignment basis until the product(s) have been used. The Government assumes no liability for assigned consignment product(s), but that the Government will be obligated only to the extent of authorized orders against the agreement. An exception to Contractor liability is loss or damage of any consignment product(s) due to Government negligence. Until such a time a requirement exists and an authorized 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. PURCHASE ORDERS/ORDERING REPLACEMENT INVENTORY: The use of any item is entirely dependent on patient diagnosis and need as determined by the attending physician. The Contractor will be paid only after items are implanted or used by the Government. MEDVAMC shall order replenishment product(s) through Contractor s Customer Service Department or designated Contractor Representative by providing a Purchase Order (PO) number after each procedure. This PO will authorize payment for the used product(s) and will also authorize delivery of the replacement product(s). The PO 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 after receipt of PO. 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. The Contractor 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. MEDVAMC 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 MEDVAMC. Contractor agrees to accept the VA Purchase Card as the preferred method of payment for opened and damaged products. ACCEPTANCE OF PRODUCTS: MEDVAMC physicians will have the responsibility to determine which item to use and Logistics staff will have final approval for acceptance of products. TECHNICAL SUPPORT: The Contractor will assign a representative to the facility to initiate and oversee the consignment inventory. At the time of the award, technical support shall 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 MEDVAMC within fifteen (15) minutes of telephone call to the Contractor. At the beginning of the award period the Contractor must provide: names of the representatives covering MEDVAMC and their direct contact information. If the vendor fails to provide the above information or the needed support the contract may be terminated. Contractor shall provide on-site, in-service training to VA personnel as needed, as well as when approval has been given to add new products to the contract. 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. CONTRACT PERIOD: The period for this consignment agreement will be for one base year with four unilateral one-year option periods. The Government reserves the right to cancel the consignment agreement at any time. TECHNOLOGY REFRESH: All stents 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 by the Contractor. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable. If upgrades of stents become available after award of this contract, the contractor will substitute them for the awarded items according to the following: 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. The COR will provide the information to the Clinical Product Review Committee for approval. Upon approval, the contract will be modified by the CO to acknowledge the updated items. All new products that replace awarded items and released to the market during the term of the contract shall 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, the VA will continue to use current products on contract and the Contractor shall be required to continue to supply the contracted item. RECALLED AND DEFECTIVE PRODUCTS: The Contractor shall submit all recall notices within the last 24 months to the COR. The COR will review and determine potential impact on clinical need. The Contractor shall notify the COR within three (3) days 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. 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 MEDVAMC. 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. RECONCILIATION AT CONTRACT EXPIRATION: Upon expiration/termination of the agreement, MEDVAMC will reconcile all consignment stock units. The Contractor will remove all unused items within ten (10) days at the end of the effective period of the agreement without reimbursement or other expense to the Government. MEDVAMC agrees to return all consignment products in saleable condition (unopened and undamaged) in the original packaging. The VA will be responsible to pay for all unsalable products. REQUIRED DELIVERABLE: At the time of the award, the Contractor will not have any outstanding actions from the Food and Drug Administration (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. The VA will require proof from the Contractor 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 CO prior to award of this agreement. Contractors that have no outstanding issues must provide a negative response to this requirement. (End of Statement of Work)
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/5fcc1997881b47c6a0f0fcb5dc237ebe/view)
- Place of Performance
- Address: Department of Veterans Affairs Michael E. DeBakey VA Medical Center 2002 Holcombe Boulevard Houston, Texas 77030
- Record
- SN06778295-F 20230806/230804230058 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |