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Statement of Need (SON) Wilkes-Barre VA Medical Center 1111 East End Boulevard Wilkes-Barre, Pa. 18711 Brand Name or Equal to a Transonic Systems HD03 Hemodialysis Monitor Background: The Wilkes-Barre... Statement of Need (SON) Wilkes-Barre VA Medical Center 1111 East End Boulevard Wilkes-Barre, Pa. 18711 Brand Name or Equal to a Transonic Systems HD03 Hemodialysis Monitor Background: The Wilkes-Barre VA Medical Center (WBVAMC) located at 1111 East End Boulevard in Wilkes-Barre, Pa.18711 is a hospital that provides outpatient and inpatient veteran care services including primary care, mental health care, specialty care services, social programs/services, telehealth services, and a community living center nursing home. There are also 7 community-based outpatient clinics. History of the Requirement: The Hemodialysis Department has a replacement requirement for one (1) Brand Name or Equal to the Transonic Systems Inc., HD03 hemodialysis monitor that has reached end-of-life (EOL) expectancy. The Brand Name or Equal to Transonic HD03 branded monitor is a replacement for the same branded unit currently used and compatible with the current hemodialysis department Baxter Hemodialysis Machines. The Wilkes-Barre VAMC Hemodialysis unit works tirelessly to provide the best possible care to our Veteran patients and having a seamless transition from the HD03 that needs to be replaced, to a new Brand Name or Equal Transonic Systems HD03 Hemodialysis Monitor, will ensure that there isn t any down time as the unit, doctors, nurses, and technicians have expert knowledge in the uses of this monitor. Summary of the Requirement: The Wilkes-Barre VAMC (station 693) has a new Brand Name or Equal to requirement for the purchase/replacement of one (1) Transonic Hemodialysis HD03 monitor. The monitor will be used in the hemodialysis department. The unit would confirm the delivered flow, detect recirculation, and measure access flow quickly, optimizing hemodialysis treatment immediately for hemodialysis patients. It does not store patient information. Detailed description of requirement: Other technologies may only detect certain types of stenosis at certain access points, whereas the HD03 monitor is unique in that it can accurately detect stenosis within any part of the access circuit. The HD03 provides on the spot vascular access, and access assessments to optimize treatment quickly and easily. 1 Transonic HD03 Hemodialysis Monitor Model number HD03 1 Patient MEAS MOD w/o PAT ID IN 1 H4FX SENSOR FOR THE HD03 Brand Name or Equal to Transonic HD03 Hemodialysis Monitor requirement request features/statements: Compatible and currently used with Baxter hemodialysis machines. (This is a must). Stand-alone unit with rechargeable battery for mobile patient to patient via IV pole portability H4FX sensors that uses transit-time burst ultrasound technology. Measurement access flow ranges up to 4000ml/min with accuracy the larger of +- 100 ml/min and +-15% of reading. Measurement delivered flow range -2 to +2 L/min with accuracy +- 6% of the flow reading +- the zero offset. Measurement recirculation range 0 to 100% with accuracy > 2% recirculation detected +- 3 % of displayed value. Replaces the same HD03 unit, providing seamless integration for patient care. Stand-alone device that measures delivered flow, recirculation, and vascular access flow during hemodialysis. Touch screen at least 8.4 Rechargeable battery for mobile patient to patient via IV pole Includes a pole mount kit. H4FX Flow sensor Incidental Services: Incidental services include but not be limited to initial training on using and maintaining the equipment. Initial on-site staff training is included in an HD03 purchase. The website Customer Portal has a full on-demand training Toolkit for ongoing educational support. The Toolkit contains training PowerPoints, videos, visual training aids, and competency checklists. Installation Requirements: No installation is required. Facility Access: N/A Delivery Instructions: Deliver equipment to Warehouse for processing: VA Medical Center 1111 East End Boulevard Wilkes-Barre, Pa. 18711 Please contact the Point of Contact (POC) with any questions or concerns. POC is Mary Lynn Makar, BSN RN Nurse Manager Hemodialysis Unit, Phone 570-824-3521 ext. 27686 and Dennelle Ripka, Warehouse Supervisor, Phone 570-824-3521 ext.27178. Delivery should occur during normal business hours. All the equipment and accessories are requested to be delivered as soon as available and possible to the VAMC Wilkes-Barre located at 1111 East End Blvd in Wilkes-Barre, Pa. 18711 between the hours of 8am and 4pm Monday thru Friday excluding all Federal Holidays. Federal holidays are: New Year s Day, Martin Luther King Jr. Day, President s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day. INSPECTION AND ACCEPTANCE a) The Contractor shall conduct a joint inspection with the COR upon delivery of equipment. b) Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s). c) The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer. WARRANTY a) The contractor shall provide a one-year manufacturer s warranty on all parts and labor. b) The warranty shall include all travel and shipping costs associated with any warranty repair. 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. SPECIAL WORK REQUIREMENTS The Contractor shall comply with 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 with VA standards, policies, and directives always set forth while providing the work outlined in the Scope of Work. 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, curbs, 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. Other special requirements or situations the Contractor should be aware of because they may affect their ability to deliver the equipment or perform the required installation or other services required. This may include vaccine requirements, TB testing results, mandatory training that needs to be completed i.e., safety, privacy, IT security etc. N/A Language from VA Handbook 6500.6 and VA Directive 6550 as indicated in the respective Appendix A forms included in Force package. VHA Supplemental Contract Requirements for Combatting COVID-19 language. REPORTS/DELIVERABLES: Delivery confirmation of equipment and commodities will be made through BioMed and the Logistics Department of the VA Wilkes Barre (693). This will include documentation of receipt and assignment of a facility based EE number for identification and tracking purposes. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving facility and/ or Service. End of Statement of Need Instructions to Vendors: The information identified above is intended to be descriptive of one (1) Brand Name or Equal to a Transonic Systems Inc., HD03 Hemodialysis Monitor. 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) 339112. 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 authorized 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. 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 Thursday July 10, 2025. This notice will help the VA in determining available potential sources only. Reference 36C24425Q0801 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 in an email 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 Sam.gov 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.