6515--MANOSCAN - HIGH RESOLUTION MANOMETRY SYSTEM, Cleveland

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice Page 3 of 12 Combined Synopsis/Solicitation Notice *= Required Field Combined Synopsis/Solicitation Notice Page 1 of 12 DESCRIPTION This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ 36C25026Q0926. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC)2026-01. This solicitation is for SDVOSB/VOSB or Small Business, under FAR Part 12. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, Surgical and Medical Instrument Manufacturing with business size of 34 million. The FSC/PSC is 6515. The Department of Veterans Affairs, Network Contracting Office (NCO)10, Louis Stokes Cleveland VA Medical Center 10701 East Blvd., Cleveland, Ohio 44106 is seeking to purchase the following, Manoscan AR CATH REG X1 with Warranty for the Gastroenterology Endoscopy Department. All interested companies shall provide quotations for the following, Brand Name, only. Supplies or Services requested: Line Item Item/Product Description Quantity Unit of Measure 1 2192 GVI 2192 MANOSCAN AR CATH REG X1 02 EA 2 SRV-HRMARCATH H-EXW GVI SRV-HRMARCATH-EXW AR CATHETER EXTENDED WARRANTY 1 YEAR 02 EA Statement of Work (SOW): STATEMENT OF WORK (SOW) MANOSCAN System and Catheter 1. CONTRACTNG OFFICER S REPRESENTATIVE (COR) Name: Louis Stokes Cleveland VAMC Section: Medical Service Address: 10701 East Boulevard Cleveland, Ohio 44106 Contracting: Jennifer A. Tisdale, Contract Specialist Phone Number: 216-447-8010 E-Mail Address Jennifer.Tisdale@va.gov 2. CONTRACT TITLE: MANOSCAN Catheter(s) with Warranty. 3. BACKGROUND: The VA Northeast Ohio Healthcare System (VANEOHS), Medicine Service Gastroenterology / Endoscopy Section, requires the procurement of two (2) replacement MANOSCAN AR catheter(s) with warranty to restore and maintain gastrointestinal motility diagnostic capability. The current MANOSCAN system and catheter utilized by Gastroenterology are non-functional, creating an immediate operational impact and limiting the facility s ability to perform high-resolution anorectal manometry studies in-house. As a result, currently scheduled patient cases will require outsourcing to external facilities, resulting in delays to diagnosis, treatment planning, continuity of care, and increased burden on Veterans requiring specialized gastrointestinal motility testing. The requested acquisition is considered an urgent operational requirement necessary to restore diagnostic functionality and maintain continuity of patient care activities within Gastroenterology and Endoscopy Services. 4. SCOPE The Contractor shall provide all labor, materials, software, hardware, accessories, delivery, setup, and support necessary to furnish and provide replacement MANOSCAN AR catheter(s) for the Gastroenterology Endoscopy Section at VANEOHS. Items must be compatible with the Medtronic MANOSCAN High Resolution Manometry (HRM) System currently being used at the hospital. The Contractor shall provide: Two (2) replacement MANOSCAN AR catheter Required software and acquisition modules System workstation and cart components Calibration setup components Delivery and operational setup Warranty support The requested system shall restore high-resolution anorectal manometry capability and support continued in-house gastrointestinal motility diagnostic testing activities. The system shall provide real-time high-resolution pressure mapping and simultaneous visualization of pressure activity across all sensor channels during diagnostic studies. All equipment and software provided shall be fully compatible and operational as an integrated system environment. 5. SPECIFIC TASKS The requested system configuration shall include: ITEM NO. DESCRIPTION QUANTITY UNIT OR STOCK NO. ADDITIONAL EQUIPMENT: 2192 1. GVI 2192 MANOSCAN AR CATH REG X1 2 EA SRV-HRMARCATH H-EXW 2. GVI SRV-HRMARCATH-EXW AR CATHETER EXTENDED WARRANTY 1 YEAR 2 EA Functional Requirements: The replacement MANOSCAN AR catheter shall: Be fully compatible with the MANOSCAN HRM system Support high-resolution pressure measurement capability Enable accurate pressure mapping of anorectal structures Support evaluation of swallowing function and pelvic floor disorders Be suitable for clinical gastrointestinal motility diagnostic procedures Delivery and Setup Requirements: The Contractor shall: Deliver all equipment FOB Destination to VANEOHS Coordinate delivery scheduling with Gastroenterology and Biomedical Engineering personnel Provide all components necessary for operational functionality Perform system setup and operational verification Ensure all software and hardware components function properly as an integrated system The Contractor shall ensure: Equipment arrives undamaged All components are operational upon delivery System functionality is restored and ready for clinical use 6. Performance Monitoring The Contracting Officer s Representative (COR) will monitor contractor performance throughout delivery, assembly, setup, and operational verification activities to ensure compliance with all contractual requirements. The COR will verify that all equipment, accessories, and components are delivered, assembled, and configured in accordance with the contractual agreement, approved specifications, and delivery schedule. The COR will also confirm that all table functions, positioning features, and accessories are fully operational and suitable for clinical use prior to Government acceptance. 7. Security Requirements The C&A requirements do not apply, and the Security Accreditation package is not required for this SOW. 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). N/A. 9. Other Pertinent Information or Special Considerations. The requested MANOSCAN AR replacement catheter must: Maintain compatibility with existing Gastroenterology diagnostic workflows Support high-resolution gastrointestinal motility diagnostic studies Function as a fully integrated system environment Support real-time pressure visualization and diagnostic interpretation The COR will verify that all equipment and accessories are installed in accordance with the contract and verify that the systems are operational upon completion. 10. Risk Control General Security: Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. Check - In Requirements: The Contractor Service Personnel and/or representative must report to the appropriate department Supervisor or designated point of contact (POC) to sign in with department staff before work begins. Additionally, one must submit any mobile media devices that would be used on the system for a virus scan. Upon completion of work, the Contractor Service Personnel and/or representative must report to the appropriate department Supervisor to brief that Supervisor or related department staff point of contact (POC) if Supervisor is unavailable concerning completion of service, and then to sign out. At the end of each briefing, Contractor Service Personnel and/or representative will and must sign out. SECURITY INCIDENT INVESTIGATION: The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. LIQUIDATED DAMAGES FOR DATA BREACH: Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for…