36C24818Q9195-003.pdf

Attachment 3: Statement of Need

Aquadex Blood Set w/Hematocrit Monitoring

GENERAL: The Medical Service at the James A. Haley Veterans’ Hospital, 13000 Bruce B. Downs Blvd, Tampa, Florida 33612, has a requirement for Aquadex blood set with hematocrit monitoring. The Blood Sets are needed to remove excess fluid from patients who are in heart failure. The Blood sets are currently being used in the Critical Care Unit, and will soon be used in Out-Patient Services.

BACKGROUND: JAHVA currently uses Aquadex in the CCU. The therapy is completely unique because it can be done in a minimally invasive fashion only requiring 3-1 nursing support. The JAHVA will be adding this service to an Out-Patient area to expand the therapy to patients without requiring an admission into the hospital. By providing this therapy in the Out-Patient Area the JAHVA can offer fluid management to Heart Failure patients who are currently being treated by community care.

SCOPE: The Aquadex Blood Sets are used to remove excess fluid from patients with Heart Failure. The therapy will be delivered to the CCU and the new Out-Patient Care Area. Aquadex is currently used in the

CCU.

SPECIFIC NEED/ SALIENT CHARACTERISTIC’S

1) Aquadex is the only fluid removal therapy in the world that can be delivered in a minimally invasive fashion. The Product is only provided by CHF Solutions who is a current vendor.

2) The Equipment comes with:

A. Aquadex fully integrated Blood Set Cartridge (LATEX FREE) B. Priming Spike Adaptor C. One Data Key D. Directions for Use Document

PERFORMANCE MONITORING: Delivery of products after placement of order within 30 days.

Monitoring will be conducted by the COR on a quarterly basis via conference or face to face meeting.

Product will be securely stored when not in use.

PLACE OF PERFORMANCE: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd., Tampa, FL 33612.

DELIVERY SCHEDULE: All items to be delivered and installed within 30 days of purchase order processing and order placement with the COR. FOB destination pricing.