6515--Cholangioscopy Image Controller (VA-26-00029891)

DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the NX EQ Cholangioscopy Image Controller: SpyGlass DS product line as a candidate for an Enterprise-wide (otherwise referred to as national ) single Requirements contract award. The Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Sources Sought Notice to determine the availability and technical capabilities of qualified sources. The SAC in conjunction with VHA is seeking a qualified source to provide Boston Scientific brand name Cholangioscopy Image Controller: SpyGlass DS product on an agency wide basis. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders in accordance with FAR 16.503, to a supplier of this equipment. Vendors will be required to deliver Cholangioscopy Image Controller: SpyGlass DS to VA medical centers and facilities throughout the United States and its territories. The anticipated period of performance is for one (1) 12-month base period with four (4) 12-month option periods from the date of award. However, the Government's decision as to whether or not to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 339113 Surgical Appliance and Supplies Manufacturing and the associated size standard is 800 employees. The FAR Provision found at 52.204-7 requires that All interested Offerors must be registered in SAM prior to submitting an offer or proposal. You may access the SAM website at Home | SAM.gov. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the Small Business Administration (SBA) database at Veteran Small Business Certification (VetCert) database at: Veteran Small Business Certification (sba.gov) at the time of proposal submission. This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. 2.0 SCOPE Cholangioscopy Image Controller: SpyGlass DS The SpyGlass Direct Visualization System is a complete system of high-resolution imaging and accessory devices designed for pancreaticobiliary stone and stricture management. The Cholangioscopy Image Controller: SpyGlass DS with Sight Shield Technology enables high resolution imaging of the bile and pancreatic ducts during endoscopic retrograde cholangiopancreatography (ERCP). Complementary SpyGlass tools enable targeted biopsies, stone fragmentation, and foreign body removal. The following Contract Line Items are being considered: Contract Line Item# Brand Part Number Description Base Period Option Period I Option Period II Option Period III Option Period IV 0001 Boston Scientific M00546650 SpyGlass Digital Controller 20 20 20 20 20 The VA is seeking vendors who can provide Boston Scientific Cholangioscopy Image Controller: SpyGlass DS as listed above which meet all the following salient characteristics (SC): SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION SC 1 Must provide illumination and receive, process, and output images from the SpyScope DS Access and Delivery Catheter during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts Literature Review SC 2 Must be FDA approved Literature Review SC3 Must have 1 year warranty Literature Review SC 4 Must have ability to control amount of Illumination Literature Review For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the SCs specified above. The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer (OEM) and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the SCs. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number. Responses to this Sources Sought Notice shall include the following: Does vendor offer an annual service plan, Yes or No? If Yes: What does the plan cover? Does plan cover software updates only? Does the plan cover parts repair or replacement only? Does the plan cover both software and parts? If applicable, vendors are requested to provide documentation that shows information on their service plan. Is the service provided by the OEM or a subcontractor? Full name and address of company SAM Unique Entity Identifier (UEI) / CAGE Code Business Size Manufacturer or Distributor If the distributor, provide manufacturer s full name, business size and address. Country of Origin designation for all products. Ability to provide uninterrupted supply of products on a national scale. Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met. Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified. Authorized Distributor Letter Certified by OEM with a current date. Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement. Contractors submitting capability statements in response to this RFI must specifically address the questions outlined above. Generic capability statements that do not directly pertain to this RFI will not be considered. Additionally, links requesting capability statements or further information will not be accessed. All responses must be submitted as an actual file attachment