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65--Continuous Veno-Venous Hemofiltration

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VA25016Q0461Federal

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The Louis Stokes Cleveland Department of Veterans Affairs Medical Center intends to negotiate a sole source contract with Baxter Healthcare Corporation for the supply of Prismaflex CVVH machines, essential for providing Continuous Veno-Venous Hemofiltration therapy. This treatment is critical for patients in the ICU who suffer from acute kidney injury, particularly those who cannot tolerate conventional hemodialysis due to conditions such as low blood pressure. Currently, the medical center operates three Prismaflex machines across various intensive care units, but demand often exceeds availability, and delays in treatment can significantly impact patient mortality. Given the vital nature of this therapy and the unreliability of rental machines previously used as backups, the center seeks to acquire additional units to ensure uninterrupted service and improved patient outcomes. The contract scope requires the supplier to provide three Prismaflex CVVH machines capable of delivering several renal replacement therapies, including CVVH, CVVHD, CVVHDF, SCUF, and Therapeutic Plasma Exchange. These machines are essential for short-term renal support in critically ill patients, enhancing recovery times and reducing overall treatment costs. The government has invoked FAR 13.106(b) to justify a sole source procurement due to proprietary access and the belief that only Baxter Healthcare can meet the agency's requirements. Other interested parties are invited to express their capability to fulfill this need by a specified deadline, after which a decision will be made whether to formally open the solicitation for competition. All inquiries regarding this procurement must be directed to the identified government contact via email.

General Info

Louis Stokes VA seeks sole source contract with Baxter for three Prismaflex CVVH machines.

Agency

N/A

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Timeline

Posted

special-notice

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Organization & Contact Information

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AgencyN/A
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Full Description

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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 BAXTER HEALTHCARE CORPORATION for supplying The Department of Veterans Affairs Medical Center, Cleveland Ohio, Medical Service with the following Prismaflex CVVH Machine Background The Prismaflex CVVH (continuous veno-venous hemofiltration) system is used to provide renal replacement therapy in critically ill patients who have acute kidney injury and are not able to tolerate conventional hemodialysis. " The Louis Stokes Cleveland DVAMC currently has 3 machines which are used in the MICU, CCU and SICU. The need for CVVH remains high, with post-operative Acute Kidney Injury, and patients with multisystem illnesses in the MICU/CCU critical care units. " The current number of units is insufficient to meet peak patient demand time while providing back up in case of failure of one of the existing units. Due to the critical need of this treatment, repair time for failed units is not an option as treatment delay directly impacts patient mortality. In the past, a rental company was used to access a CVVH machine when both VA units were in use or under repair. However, this service has become more erratic and unreliable due to demand for CVVH machines. Scope " The contractor shall provide all resources necessary to support the Electrophysiology Laboratory requirement below, at the Louis Stokes Cleveland VA Medical Center 3 EA ? Prismaflex CVVH Machine " Salient Characteristics: - Shall be capable of Continuous Veno-Venous Hemofiltration (CVVH) short-term treatment for in-patients with kidney dysfunction accompanied by low blood pressure. Therapy shall be performed in the ICU or OR setting as applicable. o The Continuous Veno-Venous Hemofiltration (CVVH) program is a short term treatment used in ICU patients with acute or chronic renal failure. Usually, hemodialysis is typically done for patients with kidney failure. However, if the patient has low blood pressure or other contraindicators to hemodialysis, CVVH may be a necessary alternative. - Shall be able to provide this treatment to ICU or post-operative patients in need of this support. Use of this system improves patient outcomes and recovery due to the limited time this support is necessary and using this intervention avoids use of full hemodialysis support in the longer term effecting shorter recovery times and cost reduction for the medical center. - The PRISMAFLEX System can be used for: o CVVHDF - Continuous Veno-Venous Hemodiafiltration o CVVHD - Continuous Veno-Venous Hemodialysis o CVVH - Continuous Veno-Venous Hemofiltration o SCUF - Slow Continuous Ultrafiltration o TPE - Therapeutic Plasma Exchange 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 Thursday August 04, 2016 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 contact@example.gov

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