Final SON Lithotripsy System.docx
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- Attached to
- BNOE Dual Action Ultrasonic/Shockwave Energy Lithotripsy System | NCO 4 Commodities 2 (VA-25-00033027)
- Solicitation number
- 36C24425Q0250_1
About this file
This Statement of Work/Statement of Need outlines requirements for one Dual Action Ultrasonic/Shockwave-Energy Lithotripsy System with accessories for the Department of Veterans Affairs Medical Center in Wilmington, DE. The system must be capable of fragmenting calculi and aspirating stone debris in the kidney, ureter, and bladder, with key requirements including integrated suction mechanism, high-frequency operation, thermal management capabilities, and FDA/FDA QSR compliance. A single probe design is preferred.
Quotes are due by 4:00 PM EST on January 17, 2025, and must be submitted via email to Contract Specialist Joanne Skaff. Required submission materials include a Letter of Authorization, accurate lead time, and product specification sheet/brochure. Delivery must be FOB Destination to the Wilmington VA Medical Center, coordinated in advance during normal business hours (7:30 AM - 3:00 PM, Monday-Friday, excluding federal holidays). All items must be delivered together unless advance coordination is made for split shipments.
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Text version
Department of Veterans Affairs Medical Center
(460) Wilmington, DE 19805 Statement of Work/ Statement of Need
Brand Name or Equal Dual Action Ultrasonic/Shockwave-Energy Lithotripsy System
1. Background:
The Wilmington VA Medical Center located at 1601 Kirkwood Highway, Wilmington, DE 19805 requires the procurement of a Dual Action Ultrasonic/Shockwave-Energy Lithotripsy System with accessories for urologic applications. This is to support the Urology clinic in meeting Veteran’s Healthcare needs.
2. Requirement:
The Wilmington VA Medical Center requires 1 Dual Action Ultrasonic/Shockwave-Energy Lithotripsy System with accessories for urologic applications. Please see Schedule B attached for additional details.
3. Salient Characteristics:
To meet the Urology clinic’s needs, the equipment must meet the following salient characteristics:
· Must be a dual action ultrasonic/shockwave-energy lithotripsy system.
· Must be capable of fragmenting calculi (stones) and aspirating stone debris in the kidney, ureter, and bladder.
· Single probe design preferred.
· Must have an integrated suction mechanism.
· Must be capable of operating at a high frequency ensuring rapid and effective stone disintegration.
· Transducers must be capable of “Thermal Management” by maintaining a low surface temperature throughout the procedure.
· Must be compliant with all relevant regulatory medical standards, including but not limited to those set forth in the FDA and/or FDA QSR regulations.
4. Delivery:
All items must be FOB Destination.
Deliveries must be coordinated in advance with the Station Point of Contact once a ship date is established. Otherwise, the delivery may be refused and require redelivery at no additional cost to the Government. The Station Point of Contact and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. Any damage to VA property by the Contractor must be repaired within 90 days at the Contractor’s expense.
Delivery days are Monday through Friday during normal work hours which are defined at 7:30am to 3:00pm. National Holidays and any other days declared by the President be treated as a holiday are excluded. The Government recognized U.S. Holidays are:
Department of Veterans Affairs Medical Center
(460) Wilmington, DE 19805 Statement of Work/ Statement of Need
New Year’s Day, Martin Luther King, Jr. Day, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Juneteenth, Thanksgiving Day, and Christmas Day. If the holiday falls on Sunday, it is observed on Monday.
Any delivery service performed for emergency orders may be delivered other than normal business work hours and must be approved by the Station prior to delivery.
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 the Station at the same time. If deliveries must be broken into several shipments due to size, then this must be coordinated in advance with the Station Point of Contract. Failure to coordinate may result in failure to deliver on site and cause rescheduling of delivery/freight at no charge to the Government.
5. Questions and Quoting
Questions should be sent to Contract Specialist, Joanne Skaff, at joanne.skaff@va.gov. Quotes are to be submitted via email to Joanne Skaff no later than 4:00PM EST on Thursday January 17, 2025. No phone calls will be accepted. Failure to submit required information may result in elimination from consideration. Quotes shall include the following:
· Applicable Letter of Authorization;
· Accurate Lead Time; and
· Product Specification Sheet/Brochure.
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