6515--Brand Name or Equal to Transonic Systems Inc. - HD03 Hemodialysis Monitor. Unrestricted

Statement of Need (SON)

Wilkes-Barre VA Medical Center 1111 East End Boulevard Wilkes-Barre, Pa. 18711

Brand Name or Equal to the Transonic 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 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

Who is the delivery POC the Contractor should coordinate delivery with? 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.

What are the hours for delivery, are there any challenges on site that might delay the person delivering the equipment to not be able to pull up to the medical center loading dock and drop off the equipment? 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

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