SOLICITATION NOTICE
66 -- Thrombo Elastograph Hemostasis Analyzer
- Notice Date
- 8/27/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA-SOL-1140628
- Point of Contact
- Daniel Weingarten, Phone: 240-402-7625
- E-Mail Address
-
Daniel.Weingarten@fda.hhs.gov
(Daniel.Weingarten@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice Type: Combination Synopsis/Solicitation This is a combined synopsis/solicitation for a Thrombo-Elastograph Hemostasis Analyzer. This is for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. a. Solicitation Number FDA-SOL-1140628 is being issued as a Request for Quotation (RFQ). b. Provisions and clauses are those in effect through Federal Acquisition Circular 2005-76, effective 25 July 2014 c. This procurement is a brand name or equal requirement, associated with NAICS Code 334516 and small business size employees 500. d. Item Description: The FDA will use this thrombo-elastograph hemostasis analyzer in its research project to evaluate the effects of medical devices and biomaterials on thrombus formation from the beginning of coagulation through clot formation to fibrinolysis. With the help of this instrument, they plan to optimize blood testing conditions and establish standardized test methods that can differentiate between the thrombo-resistant devices/biomaterials and the thrombogenic ones. The hemostasis analyzer system must meet the following Salient Characteristics: 1. Analyzing capacity: The instrument must be able to test on whole blood and measure the following parameter: (i) the rate of blood clot formation, (ii) the strength and stability of the clot, (iii) clot breakdown (fibrinolysis) process, (iv) the effects of platelets, coagulation factors, and cellular interactions on clot formation, (v) platelet functions. 2. Test fluid: must be able to test on whole blood and plasma 3. Number of testing channels: the instrument must have at least 2 independent testing channels to enable a side-by-side comparison between a subject and a control sample. 4. Blood sample volume: no more than 0.5 ml of blood must be necessary for each test. 5. Temperature control: The test temperate for each test channel must be adjustable and can maintain at a desirable temperature from room temperature to physiological body temperature (e.g. 23ºC to 37 ºC). 6. Software: The system must include computer software that produces both quantitative parameters and a graphical representation which allows the evaluation of the different phases of clotting formation and breakdown processes. The soft should be compatible with PC Windows operation system (which is currently used in the lab). 7. Portability: the instrument must weigh less than 40 lbs. 8. Power requirements: 110-120 VAC, 50-60 Hz. e. Deliverables: Thrombo-Elastograph Hemostasis Analyzer f. FAR Provision 52.212-1 (Instructions to Offerors - Commercial Items) (APR 2014) applies to this acquisition. Para (k) requires current registration in SAM at https://www.sam.gov. g. FAR Provision 52.212-2 Evaluation - Commercial Items (JAN 1999) applies to this acquisition. Award will be made to the Lowest Priced Technically Acceptable Offeror whose quote provides sufficient detail to evaluate compliance with the solicitation It is the responsibility of all interested offerors to review this site frequently for any updates/ amendments that may occur during the solicitation process. The posting of this requirement does not obligate the Government to award a contract nor does it obligate the Government to pay for any proposal preparation costs. The Government reserves the right to cancel this procurement/ solicitation either before or after the solicitation closing date, with no obligation to the offeror by the Government. The Government will issue a contract to the responsible, responsive offeror, with acceptable past performance, submitting the lowest price. All prospective contractors must be registered in the System for Award Management in order to be eligible for contract award. For registration, go to www.sam.gov and follow the instructions. h. Quotations must include a completed copy of FAR Provision 52.212-3 (Offeror Representations and Certifications - Commercial Items) (MAY 2014). Electronic submission is located at https://www.sam.gov. i. This order will include the following referenced clauses which may be accessed electronically at http://farsite.hill.af.mil. FAR 52.212-4 (Contract Terms and Conditions-Commercial Items) (MAY 2014) FAR 52.212-5 (Contract Terms and Conditions Required to Implement Statues Or Executive Orders-Commercial Items) (JULY 2014) FAR 52.219-8 (Utilization of Small Business Concerns and Small Disadvantage Business Concerns) (MAY 2014) FAR 52.232-33 (Payment by Electronic Funds-System for Award Management (JUL 2013) j. QUOTATIONS ARE DUE BY 12:00PM Eastern Standard Time on 4 SEPTEMBER 2014 in order to be considered. Send quotation responses to Daniel Weingarten @ Daniel.Weingarten@fda.hhs.gov. Assistance or questions about this announcement may be sent to the above email.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-SOL-1140628/listing.html)
- Place of Performance
- Address: US Food and Drug Administration, 10903 New Hampshire Avenue, Building 62, Silver Spring, Maryland, 20903, United States
- Zip Code: 20903
- Zip Code: 20903
- Record
- SN03483092-W 20140829/140828022427-ecae70783cb7fb88fc73fb7b1049f6d1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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