SOLICITATION NOTICE
99 -- AQUADEX FKEXFKIW/UF500 FILTER CIRCUITS/DELC DUAL LUMEN CATHETERS
- Notice Date
- 11/14/2008
- Notice Type
- Presolicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
- ZIP Code
- 02301
- Solicitation Number
- VA-241-09-RQ-0042
- Response Due
- 11/19/2008
- Archive Date
- 11/29/2008
- Point of Contact
- Christine Gorman<br />
- Small Business Set-Aside
- Very Small Business
- Description
- Friday, November 14, 2008 The Department of Veterans, VA Boston Healthcare System, has a requirement for vendor, CHF Solutions, in Brooklyn Park, MN 55428, to provide Aquadex Flexflow, UF500 Filter Circuits (BX/20) and Delc Dual Lumen Catheters to remove excess fluid from congestive heart failure patients. The details of the function of the devices can be identified in the Statement of Work. It is the Governments intention to solicit and negotiate only with this source. Please refer to the Sole Source Justification. This is not a solicitation; it is notice of intent to sole source a requirement. Inquires/information received after established deadline of November 19, 2008 shall not be considered. The submission of any data for review shall not impede award of this contract as planned. The Government does not intend to pay for information solicited. This synopsis is issued pursuant to FAR 6.302-1. Post in FBO today for 5 days i.e. 11/14/2008 9:00 am EST Deadline 11/19/2008 9:00 am EST POC:Christine Gorman, Contract Specialist e-mail: Christine.Gorman@va.gov JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION 1.Identification of the agency and the contracting activity. VA Boston Healthcare System Coronary Care Unit 2.Nature and/or description of the action being approved. Sole source procurement from CHF Solutions, Brooklyn Park, MN 55428 for Aquadex FlexFlow ultrafiltration devices. 3.Description of the supplies or services required to meet the agencys needs (including the estimated value). 523-09-1-7821-0004 for an Ultrafiltration device to remove excess fluid from congestive heart failure patients. Estimated value: $49,584.00. 4.Identification of the statutory authority permitting other than full and open competition. FAR 6.302-1, USC 253(C) (1) only one responsible sources and no other supplies or services will satisfy agency requirements. 5.Demonstration that the proposed contractors unique qualifications or the nature of the acquisition requires use of the authority cited. CHF Solutions is the only company that provides an ultrafiltration device used strictly for patients with fluid overload. Other devices used for this therapy are continuous venovenous hemofiltration devices, which are mainly used for patients with renal failure. The amount of fluid removed using these devices is much higher than with the Aquadex FlexFlow, leading to electrolyte imbalances and altered heart rates and blood pressures. Because the Aquadex FlexFlow utilizes a low volume blood circuit, these effects are eliminated, leading to safer treatment. 6.Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a Commerce Business Daily notice was or will be publicized as required by subpart 5.2 (copy attached) and, if not, which exception under 5.202 applies. Will post on FBO for 5 days from November 14, 2008 9:00 am EST November 19, 2008 9:00 am EST for 5 days. 7.Determination by the contracting officer that the anticipated cost to the government will be fair and reasonable Contracting officer will made a determination of price reasonableness at time of award. 8.Description of the market survey conducted (i.e., names of firms and the date(s) the firms were contacted) and the results or a statement of the reasons a market survey was not conducted. There are no other manufacturers that produce a product with the same features and specifications as the Aquadex FlexFlow. Edwards Lifesciences and Gambro both manufacture hemodialysis products but they are not designed solely for ultrafiltration therapy and do not have the features as described above in #5. 9.Any other facts supporting the use of other than full and open competition, such as an explanation why technical data packages, specifications, engineering descriptions, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available. The Aquadex FlexFlow by CHF Solutions is the only product on the market designed specifically for fluid overload. Other products cannot provide the low volume blood circuit that maintains electrolyte balance, heart rate, and blood pressure. 10.A listing of the sources, if any, that expressed, in writing, an interest in the acquisition. None to date. 11.A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. VA will try to look for the same kind of equipment in the Open Market for the future orders. Statement of Work Vendor is to provide items: 1)Aquadex Flexflow (including Cart and 2 Year Service Plan) 2)UF500 Filter Circuits (BX/20) 3)Delc Dual Lumen Catheters An Ultrafiltration device to remove excess fluid from congestive heart failure patients as identified Section B (Schedule of Supplies/Services & Prices/Costs) for the items with the terms and specifications of this contract. Aquadex FlexFlow Console Key Clinical Features: Peripheral or central venous access options Catheter options include peripheral IVs, midlines or central Fluid removal adjustable from 10 to 500 ml/hour in 10 ml/hour increments Blood flow settable from 10 to 40 ml/min in 5 ml/min increments Total extracorporeal blood volume of 33 ml Convenience Features: Small and easily transportable perform therapy when and where needed Simplified loading and automated priming Single-button operation to begin treatment All alarms are set-up and active automatically Onscreen pressures display Safety Features: Integrated pressure sensors monitor for circuit disconnection and occlusion Ultrasonic air detection of 50 microliters of air Photometric Filter membrane blood leak detector Weight scale verification of fluid removal rate Maximum removal rate of 500 ml/hour Technical Features: 100/240 VAC, 50/60Hz Maximum power consumption, 100VA Internal NiMH battery supports 30 minutes of operation Compliance with IEC-601-1- (electrical safety) and IEG-601-1-2 (EMC) Easy on-location software upgrades UF 500 BLOOD CIRCUIT SET Designed to minimize blood volume, clotting, and electrolyte imbalance Single-use and disposable Presassembled and fully integrated: Tubing and Connectors, Filter, and Pressure Sensors Easy loading cartridge clips Convenient access ports for easy connection PRODUCT COMPARISON PRODUCTWATERSALTRESULTS Aquadex Flex Flow6+ Liters12 Gramsat 90 days: 50% Re-hospitalization episodes- 63% Total re-hospitalized days- Standard Care1 Liter1 Gramat Discharge: 40% patients still symptomatic+ 20% patients re-admitted at 30 days or less+ 48% weight gain or less than 5 lbs loss
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=629d2be480f5af1f0bd3fb0191aebad7&tab=core&_cview=1)
- Place of Performance
- Address: VA Boston Healthcare System;WR-CCU;1400 VFW Parkway;West Roxbury;MA<br />
- Zip Code: 02132<br />
- Zip Code: 02132<br />
- Record
- SN01704826-W 20081116/081114215552-629d2be480f5af1f0bd3fb0191aebad7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |