SOLICITATION NOTICE
66 -- Analyzer
- Notice Date
- 7/31/2009
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1062341
- Point of Contact
- William T. Lee, Phone: 3014435863, Doreen Williams , Phone: 301-827-3366
- E-Mail Address
-
william.lee@fda.hhs.gov, doreen.williams@fda.hhs.gov
(william.lee@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 334510, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. This solicitation is posted full and open to all qualified businesses and will be awarded as a Firm Fixed Price Purchase Order. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Center for Devices and Radiological Health (CDRH) has requested the purchase of an Hermatology Analyzer and Accesories which will be used to provide rapid and accurate measurements of complete blood cell counts (CBC) and other blood parameters for the Blood Damage Assessment Laboratory in CDRH/OSEL. This instrument is essential to our research, because we regularly conduct experiments with human and animal blood and it is necessary to know the hematological parameters for each test. Blood cell fragility is a serious issue for a variety of medical devices. This instrument is needed to quantify cell properties that affect blood fragility during the safety evaluation for the universe of medical devices. This will include collaboration with NIST. Consequences of not funding: Without this system, OSEL is hampered in its ability to asses blood damaging performance of a wide array of cardiovascular products.. This solicitation is issued as a Request for Quotation (RFQ) The Food and Drug Administration (FDA) intends to award a Firm Fixed Price Purchase Order for the acquisition of an Hermatology Analyzer and Accesories. The offer for this equipment must meet the following specifications and evaluation criteria: Performance Specification Requirements: The hematology analyzer must conform to the following key specifications: 1. Species: capable of testing human and animal blood; it must be able to test blood from at least 10 species, including human, cow, sheep, pig, rabbit, rat, and mouse. 2. User-defined procedure settings: must allow users to program optimal procedure settings to meet specific needs; programming should be performed on site after the instrument is delivered; once settings are installed, different blood samples can be run at their appropriate settings with the push of a button. 3. Measuring parameters: capable of measuring complete blood cell counts including red blood cell (RBC) count, white blood cell (WBC) five-part differentiation, platelet count, mean cell volume (MCV), hemoglobin, and hematocrit. 4. Sampling: requires no more than 50 μL blood per sample to accommodate small sample volume; the sampling probe should be automatically cleaned after sampling. 5. Measurement cycle time: no longer than 2 minutes per sample. 6. Counting chamber: cell flow system should allow the cells to pass through the counting zone one at a time to ensure accurate single-cell analysis, especially for species with very high cell counts. 7. Precision (CV): RBC < 3%, WBC < 3%, platelets < 5%, hemoglobin < 2%, MCV < 1%. 8. Linearity range: WBC: 1 - 200 x 103 cells/μL, RBC: 0.1 - 20 x 106 cells/μL, platelets: 1 - 1000 x 103 cells/μL, hemoglobin: 0.1 - 20 g/dL, MCV: 30 - 100 fL. 9. Quality control: must have a quality control product available that is specific to the instrument in order to verify its accuracy. 10. Flagging: automatically flags abnormal results specific to a certain species; the system should be able to discern between platelets and RBC fragments and flag the result if excessive RBC fragments are present. 11. Computer interface: must have computer interface to export CBC data to Microsoft Excel for data analysis 12. Reagent stability: reagent shelf life should be at least 9 months and should be stable for more than 30 days after opening. 13. Ease of maintenance: does not require time-consuming daily or weekly system maintenance; can perform automatic daily and weekly cleaning; if necessary, the unit can be opened and serviced by trained users without voiding the warranty. 14. Warranty and Service: must have at least a one-year warranty and the service after warranty expiration can be obtained by way of a service agreement. 15. Power requirements: 120 V, 50/60 Hz. FOB: Destination EVALUATION AND AWARD: The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The award will be made to the offeror whose proposal conforms to the terms and conditions of the solicitation under a Firm Fixed Price Purchase Order. Technical Requirements: The technical evaluation for this solicitation will be the equipments ability to meet the required specifications, the contractor’s ability to service the equipment with readily available service personnel. The ability to support the technical requirements will comprise the major percentage of the evaluation factors. Warranty: Warranty shall be at least one year and the service after warranty expiration can be obtained by way of service agreement. Warranties must be explicitly stated for the instrument. The vendor will have an established record of being able to service their systems. Evaluation for Award: The award will be made to the party whose quote offers the best value to the government, technical, price and other factors considered. The Government may award this purchase order to other than the lowest priced technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor “Meeting or Exceeding the Technical Requirements”; 2) Warranties; 3) Price and 4) Past Performance of product. Meeting the Technical Requirements is significantly more important than price. The FDA intends to make an award immediately after the response of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to William.lee@fda.hhs.gov no later than August 7, 2009, 4:30 p.m. EST. QUOTATIONS DUE: All quotations are due, via email to: william.lee@fda.hhs.gov, no later than August 18, 2009, 4:30 p.m. EST. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.232-33 and FAR 52.217-9. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to william.lee@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1062341/listing.html)
- Place of Performance
- Address: White Oak Campus, FDA, 10903 New Hampshire Avenue, Bldg 66, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01895368-W 20090802/090801000403-d9d188fad9ff4acfa6204d1d310c255a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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