This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract pursuant to 10 U.S.C 2304 (C)(1), as implemented by FAR 6.302-1(a)(2) and 6.301-1(c), only one responsible source and no other supplies or services will satisfy agency requirements, and brand-name descriptions. The Department of Veterans Affairs Medical Centers located at Providence RI has a requirement for a Shockwave IVL System. The Government intends to award a firm-fixed-price sole source contract. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. this notice of intent is not a request for competitive proposals. This is a written notice to inform the public of the Governments intent to award on a sole source basis. Interested parties may identify their interest and capability to respond to the requirement. Any response to this notice must show clear and convincing evidence that competition will be advantageous to the Government. Please contact Manasés Cabrera, Contracting Specialist with the responses or questions regarding this requirement at manases.cabrera@va.gov. This notice will close on April 24, 2023, at 2:00 PM Eastern Standard Time (EST) STATEMENT OF WORK SCOPE OF WORK: The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following: Delivery of The Shockwave Medical Intravascular Lithotripsy (IVL) System comprised of the IVL Generator and Connector Cable Kit, IVL Standalone Connector Cable, IVL Kits, and IVL Catheters. 1. EQUIPMENT The following equipment shall be provided and installed by the Contractor in the space determined by the Government. All equipment installed by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable. The Shockwave Medical Intravascular Lithotripsy (IVL) System comprised of the IVL Generator and Connector Cable Kit, IVL Standalone Connector Cable, IVL Kits, and IVL Catheters. The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation. 2. SALIENT CHARACTERISTICS The Contractor shall provide a fully functional system that meets the following characteristics: This SOW is for a specific brand name procurement, the Shockwave intravascular lithotripsy (IVL) system, for the treatment of severely calcified coronary artery plaques. The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment. This feature is designed to automatically set pulse parameters unique to each catheter type. Generator is portable and rechargeable. Specifications of the IVL Generator are: 10.1 Appendix C1: General Specifications Specifications Performance Characteristics Alarms Built in tests and monitors are designed to detect and annunciate designated malfunctions of subsystems within the Generator. The Generator is designed to interrupt therapy delivery in the event a malfunction is detected. In addition, visual annunciators (CATH or SYS) will activate and three beeps will sound. See Sections 4.1 (Tones), 7.0 (Troubleshooting) Classification, Product Class II Medical Electrical (ME) Equipment Classification, Applied Parts Type CF Connectors (Connector Cable) OnAnOn 150PT series with proprietary keyway Data Log No data associated with patient cases is logged Enclosure Non-ventilated, polymeric enclosure, molded from flame retardant UL 94V-0 rated material Environmental Altitude: 0 - 2000 meters Humidity, operating: 10 70% non-condensing Temperature, operating: 10° to 35°C Temperature, storage / shipping: -20° to 65°C Electrical Safety ISO 60601-1 (2012) edition 3.1 standards EMC Compatibility See Appendix A Mobility Product is designed to be mounted to a stable mobile or stationary IV pole. An IV pole with five casters located in a circular pattern with a diameter of at least 23 inches (58 cm), such as the I.V. League Ventilator Stat-Stand model 1059 (or equivalent) is recommended. Power 90-240VAC; 50-60Hz; Single Phase, 15A service Protectively earthed Size 11 (28.0 cm) high x 6 (15.2 cm) wide x 11.5 (29.2 cm) deep Shock Shipping Shock per EXD-007C ASTM D 4169-09 Splash Resistance 10 mL saline from above (Generator) 100 mL saline from any angle (Connector Cable distal end) Weight 6 pounds (2.7 kg) The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and used to activate lithotripsy energy within the IVL balloon catheter. The IVL M5 Catheter is a lithotripsy device delivered through the peripheral arterial system of the lower extremities to treat calcified stenosis. The IVL M5 Catheter is comprised of an integrated balloon with lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The IVL M5 Catheter is available in nine (9) sizes: 3.5 x 60mm, 4.0 x 60mm, 4.5 x 60mm, 5.0 x 60mm, 5.5 x60mm, 6.0 x 60mm, 6.5 x 60mm, 7.0 x 60mm, and 8.0 x 60mm. The S4 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable. 3. AREAS TO BE SERVICED. (one or all as necessary and appropriate to this contract) Department of Veterans Affairs VA Providence Healthcare System 830 Chalkstone Avenue Providence, RI 02908 4. INSTALLATION The Contractor shall provide all labor, materials, tools, equipment and etc. to prepare for and complete the installation of the equipment in the space determined by the Government. Project implementation meetings, if necessary, shall be coordinated with the COR. Installation and implementation dates are to be coordinated in advance with the Contractor and the COR. All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access. All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government. All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work. The Contractor shall communicate to the Government the estimated downtime required to complete full installation and testing AIO computer. If the Contractor is unable to install the equipment to its normal operational state within 24 hours the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment. The Contractor shall be responsible for the safe removal and disposal of all trade-in equipment as applicable. The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation. 4. TRAINING NA. Personnel are familiar with the equipment. 5. INSPECTION AND ACCEPTANCE The Contractor shall conduct a joint inspection with the COR upon delivery of equipment. Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s). The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer. 6. WARRANTY The contractor shall provide a manufacturer s warranty on all parts and labor. The warranty shall include all travel and shipping costs associated with any warranty repair. 7. TASK FREQUENCY AND INSTRUCTIONS The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR. Equipment delivery shall not precede installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including go live support. Implementation and integration with Vista CPRS shall not exceed 90 days from date of award. 8. SPECIAL WORK REQUIREMENTS The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the Providence VA Medical Center during all portions of the work set forth in the Scope of Work. The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work. 9. PROPERTY DAMAGE The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (e.g. trees, shrubs, lawn/turf, cubs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer. 10. ATTACHMENTS None. 11. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS The contractors employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate desig nated park ing areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking viola tions of the con tractor under any con ditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two way radios are not to be used within six feet of any medical equipment. Posses sion of weapons is prohibited. Enclosed containers, including tool kits, shall be sub ject to search. Violations of VA regulations may result in a citation answer able in the United States (Federal) Dis trict Court, not a local district state, or municipal court. 12. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall: A. Have methods by which all employees are educated as to risks associated with blood borne pathogens. B. Have policies and procedures which reduce the risk of employee exposure to blood borne pathogens. C. Have mechanisms for employee counseling and treatment following exposure to blood borne pathogens. D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, and mouthpieces for the employee during performance of the contract. 13. INFORMATION SECURITY LANGUAGE None 14. Records Management Language for Statement of Work (SOW):  The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: 1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. 2.Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. 3.Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.  4.Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.  Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.   The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].   No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.   Contractor is required to obtain the Contracting Officers approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.Â

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