65--541-14-3-250-0357 Fibroscan

INTENT TO SOLE SOURCE FAR 13.106(B) This is a notice of intent of The Louis Stokes Cleveland Department of Veterans Affairs Medical Center, 10701 East Boulevard, Cleveland, Ohio 44106 to negotiate sole source with Sandhill Scientific, Inc. for supplying The Department of Veterans Affairs Medical Center, Cleveland, Ohio, Medical Service, with: ITEM NO. DESCRIPTION QUANTITY 1 FibroScan 502 Touch w/M+ & XL+ Probes 4 EA FibroScan is used in the clinical management of patients with liver disease by assessing liver shear wave speed (expressed in meters per second) and equivalent stiffness (expressed in kilopascals) at 50 Hz in a rapid, simple, non?invasive and totally painless way. Estimated delivery: 4 weeks ARO FibroScan probes M+ & XL+ The M+ probe: Transducer frequency is 3.5 MHz XL+ Probe: A more sensitive ultrasound sensor at the frequency of 2.5 MHz has been designed to enhance deeper signal penetration on patients with obesity 2 Comprehensive Service Agreement 4 EA This Plan covers One Annual Probe Calibration for two (2) FibroScan probes Guaranteed loaner probe for calibration 20% off the list price for repair parts On?Site Training: one (1) visit per year On?Site Repairs: one (1) per year; labor and travel included. Repair parts are not included. Your coverage under this Plan is effective beginning on the first day following the end of the warranty period and will expire one (1) year from this effective date. This one (1) year plan (FBS?CSA) can be purchased annually. These instrument are used in the clinical management of patients with liver disease by assessing liver shear wave speed (expressed in meters per second) and equivalent stiffness (expressed in kilopascals) at 50 Hz in a rapid, simple, non-invasive and totally painless way. This device would allow the Medical Centers to reduce the number of invasive procedures (liver biopsy) needed in the evaluation for chronic liver disease, particularly in patients with chronic hepatitis C and fatty liver disease. The risks of the evaluation would be dramatically reduced (liver biopsy is associated with a significant risk of pain and bleeding), as well as patient comfort and satisfaction with evaluation. It would also allow the Medical Centers to increase the number of patients with adequate assessment of fibrosis, resulting in improved delivery of standard of care to our veterans. With the imminent approval of new hepatitis C treatment agents, the adequate assessment of liver fibrosis pre-treatment will be essential to determine the ideal duration of treatment for patients with chronic hepatitis C; adequate fibrosis assessment pre-treatment may minimize the costs of hepatitis C treatment. Furthermore, as the toxicity of the drugs available for the treatment of chronic hepatitis decreases, the risks of invasive assessment of fibrosis with liver biopsy are harder to justify. The Government believes that only one business can satisfy the agency requirements and intends to negotiate with only one source under the authority of FAR 13.106(b) - access to proprietary information. Other persons may identify their interest and capability to respond to this requirement by Friday August 8, 2014 at 3PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time. All inquiries must be submitted by email to Christopher Callihan at Christopher.callihan@va.