36C24418Q9609-001.docx

STATEMENT OF NEED

GENERAL:

The Urology Department, located within the Wilmington VAMC, Wilmington, DE proposes purchasing a fusion biopsy system. The radiologist uses Dynacad program to take an image of the prostate which is used to identify patient’s suspicious lesions. This information is sent through the fusion biopsy system which stores combined images of the MRI and ultrasound to allow the urologist to better identify where to take a biopsy.

SPECIFICATIONS:

· The system must be compatible with Dynacad Prostate.

· Ultrasound-only workflow for guided navigation without the need for pre-biopsy MR data.

· Display of prior biopsy core locations and data from previous procedures performed with UroNav.

· 3D gland segmentation modeling and flexibly to perform dynamic adjustments of the ultrasound segmentation boundary.

· Systematic biopsy planning and needle placement guidance for samples.

DELIVERY:

Awarded Contractor shall provide all equipment and materials required for installation within thirty (30) days after contract award.

The contractor shall deliver all items at no additional cost. All deliveries shall be made Monday- Friday, 8:00 a.m. – 3:30 p.m.

3. PRICING SCHEDULE: VA anticipates award of a contract on a firm fixed unit price basis.

4. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE:

4.1 Backorders: If there is a backorder on any of the requested items, the contractor must contact the VA no later than 24 hours. The contractor will offer the VA substitute of equal or higher quality. If acceptable to the VA, the substitute may be made part of the contract with a bilateral modification.

4.2 Warranty: The contractor warrants/guarantees all items against defective material and/or workmanship for a minimum of one year from the date of receipt. The contractor agrees to furnish without additional cost to the government, all labor and materials necessary to correct defects that were detected during the guarantee period.

4.3 The Contractor shall immediately notify all affected VA’s and contracting activities in the event of a product recall, removal, required adjustments, or required modification that is suggested or mandated by the contractor, distributor, manufacturer, or any regulatory or official agency. The information that shall be included in this notification include:

1. A complete item description, identification.

2. Administrative identification data including contract number, order numbers, and order date.

3. Reasons for recall, removal, adjustment, or modification.

4. Instructions for appropriate corrective action.

5. EDUCATION/ TRAINING:

5.1 The contractor shall provide any and all technical training required in order for VA staff to fully utilize the equipment. This includes face to face training by provided by the vendor. Training of staff shall be completed within two (2) weeks after installation.