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Statement of Need/Work 1. Title of Project: CVi Standard Contrast Injector System 2. Background and Scope of Work: The VA Pittsburgh Healthcare System (VAPHS) has new requirement for a brand name only... Statement of Need/Work 1. Title of Project: CVi Standard Contrast Injector System 2. Background and Scope of Work: The VA Pittsburgh Healthcare System (VAPHS) has new requirement for a brand name only purchase of one (1) ACIST CVi Standard Contrast Dye Injector System w/ 7-year warranty, and Mobile Cart for the VA Pittsburgh Healthcare System (VAPHS) Cardiology Section. The Contrast Injector System is designed to provide an advanced adjustable-rate contrast injection system developed for use in various cardiac and vascular angiography procedures, which include coronary, ventricle, aorta, and peripheral vasculatures. Replacing current equipment with the same platform, only newer technology, will reduce the amount of negative impact on patient access and staff learning curve. This platform utilizes a multi-patient contrast syringe that reduces the amount of wasted contrast. This added feature results in less spending for consumable products and was especially helpful when supply chain issues caused a global contrast shortage. The CVi Standard Contrast Injector System features: Designed to provide an advanced, controlled, adjustable-rate radiopaque contrast media and/or saline to patient for various angiographic cardiac and peripheral procedures. Contains a motor-driven pump that delivers contrast media and saline from the injector to the patient by catheter or sheath. Programmable rates/modes: Flow rate: Fill 1-2 ml/s and air purge 6ml/s Volume Pressure Rise time Saline: automated fixed flow rate, 1.6 ml/s with a maximum injection volume of 16 ml/saline injection activation Operation Modes: Injection selection Mode selection End case Pre-programmed Cardiac and Peripheral Inject-Saline-Purge-KVO Hand controller calibration Must provide transducer backplate sensor. Able to monitor blood pressure through system simultaneously with current hemodynamics recording system. Greatly reduces the amount of Contrast used during procedures, minimizing negative affects to patient s kidneys. Able to be installed on a pedestal cart or procedure table rail. Includes all required cables/connections to operate contrast injector system. System components: Control panel: Main user display Contains: Armed indicator light, touchscreen, standby button, luer-lock connections for hand controller, control panel connection, and speaker Swivel base for easy rotation for optimal viewing Injector head: Contains the motors, pumps, sensing elements, and software that control contrast and saline delivery. Sensors: Air column detection, Manifold valve, Contrast, and Syringe valve Luminescent Backlight: For visualization of air detection Syringe chamber Able to be pedestal cart or procedure bed rail mounted. Mobile cart Power supply Communication, Power, and X-Ray synchronization cables Compatible with current: Contrast syringe, injection tubing, and manifold Philips Allura X-Ray System Philips Xper Hemodynamics Recording System GE Mac Lab Monitoring / Charting system Warranty: Standard 7-year manufacturer s warranty In addition to increased procedural effectiveness and safety, this technology can lead to improved clinical outcomes in procedures requiring contrast injection. 3. Data/Deliverables: Item Number Item Description Quantity 016715 CVi Standard Contrast Injector System w/ 7-Year Warranty 1 014668 Mobile Cart 1 4. Scheduling, Hours of Work, and Location: Deliver all line items specified under Data/Deliverables to point of contact during normal operating hours, M-F 8:00am 4:30pm: VA Pittsburgh Healthcare System University Dr Pittsburgh, PA 15240 The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government. Normal business hours for acceptance of deliveries are 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with COR once a ship date is established. The COR, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR. Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number. Training: Any training scheduled should be coordinated with the COR and VA staff. Additional Charges: There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts or installation. There will be no additional charges for time spent assembling the bladder scanners. There will be no additional charges for any time spent on-site provided training to either clinical or technical staff. There will be no additional charges with the waste management protocol listed in section 8. HIPAA Training Certificates: If, Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract. Tobacco: All VA Pittsburgh property is tobacco free. Contractor personnel will comply with VA Pittsburgh tobacco and smoking policies. Violations will result in a warning and possible citation. COVID-19 Related Policies: Upon entering VAPHS, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by VAPHS. All individuals are required to enter through the main entrance for temperature screening. If Contractor s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement. Instructions The information identified above is intended to be descriptive of the Brand Name Only ACIST - CVi Standard Contrast Dye Injector System w/ 7-year warranty, and Mobile Cart to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339113. Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? (4) If you are 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). (5) Describe how your small business takes ownership of the equipment in the manufacturing, assembly, or delivery process. (6) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (7) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. (8) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. (9) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (9) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (10) Please submit your capabilities regarding the brand name equipment. (11) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Responses must be received via e-mail to david.santiago2@va.gov, no later than, 4 PM Eastern Standard Time (EST) on November 3, 2023. This notice will help the VA in determining available potential sources only. Reference 36C24424Q0061 in the subject of the email response. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contract Specialist, David Santiago. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the Beta.Sam web site for all qualified interested parties at a later date and interested parties must respond to this Sources Sought Notice to be considered for a set-aside. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contract Specialist at david.santiago2@va.gov DISCLAIMER This RFI 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. 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.