65--FibroScan® 502 Touch Brand Name Only

Added:
Jun 07, 2017 12:36 pm
STATEMENT OF WORK (SOW)

FibroScan


The Salt Lake City Veterans Health Care System is in the need to purchase the FibroScan system. Medicine Services will use the FibroScan to diagnose and treat patients with liver disease. The FibroScan will monitor and detect hepatic steatosis and by utilizing transient elastography to identify veterans with NAFLD and significant fibrosis. The system will also assist in guiding HCV anti-viral therapy based on the fibrosis status. Determine the need for HCC surveillance before and after SVR. Monitor fibrosis progression in treatment naà ̄ve or failure veterans who cannot undergo treatment. Monitor fibrosis regression after SVR. Less sampling error compared to liver biopsy.

Description
Implementation of the FibroScan502Touchr will provide a crucial tool for the treatment and diagnosis of Hepatitis patients and NAFLD-NASH. Salt Lake City VA will be able to quickly implement the

FibroScan502Touchr platform and will provide a cost-beneficial method for treating the veteran population that suffers from Liver Disease. FibroScan technology has been validated in over 1300 publications on the effectiveness, efficacy and accuracy of VCTE and CAP to help aid Physicians in their treatment of Liver Disease.

The Device is designed specifically for use in the liver with the goal of providing consistent quantitative results, over time and among different operators. The Device uses factory settings to guide the operator for proper probe selection, positioning, and pressure. Each exam consists of 10 painless readings, from which the median result will be taken and variability assessed. While there is no formal certification required for users, the user will be trained on the use of this device. As a non-invasive measure of liver stiffness, this device provides an improved patient satisfaction over invasive modalities, and appears to meet the expectations of patients

SALIENT CHARACTERISTICS
Basis of Design: FibroScan® 502 Touch Brand Name Only
Quantity: 1
Specifications/Salient Characteristics:
Proposed device must include - M/XL Probe, Cap Software, Install, Training, and 1 Year
Premium Service:
- Includes initial training session at time of installation and one on-site follow up training session within 12 months (up to 6 certified operators total).
- includes Annual probe calibration, Fibroview Report, All Inclusive On-site training, All Inclusive Repair parts, All Inclusive On-site repair, All Inclusive Guaranteed loaner probe for calibration, All Inclusive DICOM Connectivity & Maintenance, All Inclusive Fibroview Data Solution & Maintenance, All Inclusive Loaner FibroScan (*If on site repair exceeds 5 business days).
Hardware
17 Touch Screen
Optimal comfort & image quality in all situations
High contrast & brightness
Wide viewing angle
Advanced electronics for fast and effective examination
High speed elastrometry engine
Front and rear handles
Easy to move and manipulate
Smart Tools
Automated Probe Selection
Indicator to recommend the probe best suited to the patient s morphology
Liver Targeting Tool
Indicator to help select the optimal measurement point
Characterizes the quality of the ultrasonic signal
Pressure Indicator
Provides visual feedback on the applied pressure prior to taking a measurement
FibroScan reports
Generate and edit reports
Personalize reports with hospital logo and address
Print report
Archive PDF Report
Probes
Two different ergonomic probes enable you to address a full range of clinical and morphological needs. These probes should be designed to ensure reliable data in all patient types.
Software
Tactile interface with a new design
Optimized ergonomy & data workflow
User-Friendly interface
Easy to use
Patient data management
Organized by patient data
Multi-criteria search
DELIVERY
Delivery Timeframe: Medicine Services, Internal Medicine no earlier than June 15, 2017 and no later than July 15, 2017. The Contractor shall contact the Onsite POC to schedule a pre-delivery meeting to be conducted approximately 60 days prior to the initial award delivery date for verification of delivery dates. The Contractor may be required to adjust the delivery date from the date specified in the contract award document. A government-requested delivery delay of up to 90 days after the delivery date specified in the contract award shall be at no additional cost to the government.
Delivery Location: Contractor shall deliver all equipment to the Salt Lake City Health Care System:

500 Foothill Drive
Salt Lake City, UT 84148.

Items on delivery vehicles not equipped with a Lift Gate will not be accepted. The delivery will have to be rescheduled and any delivery charges will be the responsibility of the Contractor.
Delivery Markings: Contractor shall deliver items in manufacturer's original sealed containers with manufacture s name marked thereon. Deliveries shall be marked with the PO# and contract number. Delivery shall be coordinated through the Onsite POC.
INSPECTION AND ACCEPTANCE
The Contractor shall conduct a joint inspection with the Onsite POC upon completion of delivery. In the event deficiencies are identified, the Contractor shall provide a date when the identified deficiencies will be addressed if not addressed on the date of delivery. All deficiencies identified during joint inspections shall be fixed by the Contractor prior to government acceptance of the item. Disputes shall be resolved by the Contracting Officer.

OPERATION AND MAINTENANCE MANUALS
Binders - Quantity (2) each
Digital Copies - Quantity (1)
Deliver compilation of all manufacturer recommended maintenance schedule and operation materials packaged in binder(s) to Onsite POC upon completion of delivery.
OPERATOR TRAINING
Contractor shall provide all training materials at time of delivery.

PROTECTION OF PROPERTY
Contractor shall protect all items from damage during delivery. The Contractor shall be responsible for repairing or replacing any items, components, building(s), or grounds damaged due to negligence and/or actions taken by the Contractor or its employees. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and Onsite POC is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work.
The Contractor shall be responsible for securing the items and its own work tools and equipment during delivery.

SECURITY REQUIREMENTS
Security background checks are not required. The contractor will provide necessary documentation for equipment access to patient/VA information.

WARRANTY
The contractor shall provide all manufacturer(s) warranties on all parts and labor at time of delivery. The warranties shall include all travel and shipping costs associated with any warranty repair.


Scope
The contractor shall deliver all items as stated in the SOQ no later than 07/10/17.

Items to be purchased:
Brand Name Only
FibroScan 502 Touch Package - M/XL Probe, Cap Software, Install, Training, and 1 Year
Premium Service FibroScan 502 Touch Package with M Probe, XL Probe, Cap Software, Installation, Training, and 1 Year Premium Service Plan - Includes initial training session at time of installation and one on-site follow up training session within 12 months (up to 6 certified operators total). Premium Service 1
Year includes Annual probe calibration, Fibroview Report, All Inclusive On-site training, All Inclusive
Repair parts, All Inclusive On-site repair, All Inclusive Guaranteed loaner probe for calibration, All
Inclusive DICOM Connectivity & Maintenance, All Inclusive Fibroview Data Solution & Maintenance,
All Inclusive Loaner Fibroscan (*If on site repair exceeds 5 business days)

END OF STATEMENT OF WORK