SOLICITATION NOTICE
66 -- Copas Biosort Flow Cyctometer
- Notice Date
- 7/23/2009
- 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
- FDA-SOL-09-1058963
- Archive Date
- 9/21/2009
- Point of Contact
- Dominique H Malone, Phone: (301) 827-7227, Dominique H Malone, Phone: (301) 827-7227
- E-Mail Address
-
dominique.malone@fda.hhs.gov, dominique.malone@fda.hhs.gov
(dominique.malone@fda.hhs.gov, dominique.malone@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The award will be made under the authority of FAR 13.5 Test Program for Certain Commercial Items. Offerors are hereby informed that this requirement is brand name or equal. The Food and Drug Administration intends to award a competitive purchase order for a Copas Biosort flow cyctometer. There is a need in the FDA to reduce, replace and refine existing animal use in the assessment of the toxicity of food contaminants (e.g., direct and indirect food additives and bacterial pathogens). Alternative testing methods should be faster, cheaper than and as accurate as existing methods. The solution to this problem is to evaluate the predictive performance of the nematode worm, C. elegans, as an alternative animal model in toxicity assessment and develop validated testing methods for using C. elegans in toxicity testing. This project will utilize the Complex Object Parametric Analyzer and Sorter (COPAS) to assess the effect of a number of known food related toxins on growth, development, fecundity, longevity etc. in C. elegans. High throughput tests utilizing COPAS state of the art technology will be developed and thresholds or levels of detection for known toxins will be established. The Complex Object Parametric Analyzer and Sorter (COPAS) automates the analysis, sorting, and dispensing of nematodes (C. elegans) while measuring their size, optical density, and the intensity of fluorescent markers. Once analyzed, nematodes can be sorted according to user selectable criteria, and then may be dispensed into stationary bulk receptacles or multi-well microtiter plates for high throughput screening. COPAS instruments have been proven to analyze and sort large objects with a higher speed and precision than present manual techniques. By automating the current, time consuming manual processes, the time required for experiments is dramatically reduced, human error is eliminated, and new experiments that previously could not be considered are now possible. This research will benefit the FDA in that the FDA will have validated methods that are faster, less expensive than and as accurate as present day methods for the identification of potential food contaminants. These high throughput methods will allow the FDA to fulfill its mission to protect the American public and at the same time allow the Agency to move one step closer to achieving the mandate of reducing, refining and replacing animal testing methods. (ii) This solicitation is being issued as Request for Quotation (RFQ). (iii) This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-35. (iv) A notice regarding any set-aside and the associated NAICS code 334516 Analytical Laboratory Instrument Manufacturing and small business size standard of 500 employees. (v) A list of contract line item number(s) and items, quantities and units of measure: Below are the item names and a general description of the salient physical, functional, and performance characteristics of the brand name item that an “equal” item must meet to be acceptable for award. CLINEquipment/Part No.Quantity UnitFirm Fixed Price CLIN 0001BIOSORT 350-5000-000One (1) EA CLIN 0002488nm Solid State Laser Option 550-7301-000One (1) EA CLIN 0003Sample Recovery 344-5001-000One (1) EA CLIN 0004Advanced Acquisition Package 380-5000-200One (1) EA CLIN 0005Profiler II Software Package 380-5000-300One (1) EA CLIN 0006Accessory Pack (110V) 3XX-5098-000One (1) EA CLIN 0007Air Compressor(120V) 300-7000-001One (1) EA CLIN 0008Warranty One (1) EA (vi) Description of equipment and supplies to be acquired: CLIN 0001 BIOSORT 350-5000-000; QUANTITY ONE (1) EA The COPAS BIOSORT flow cytometer is a continuous flow system capable of analyzing small and large quantities of objects using five parameters: size, optical density, and up to three spectrums of fluorescence. Relative size is measured by an axial light-loss detector which records the time that the light blockage signal remains above a pre-set threshold level; optical density is determined by the total integrated signal of the light blockage. The fluorescence and large quantities of objects using five parameters: size, optical density, and up to three spectrums of fluorescence. Relative size is measured by an axial light-loss detector which records the time that the light blockage signal remains above a pre-set threshold level; optical density is determined by the total integrated signal of the light blockage. The fluorescence intensity can be simultaneously measured at three different wavelengths by the excitation and emission filters in the system. Sorting and dispensing decisions are based on user-selected ranges using the proprietary COPAS software. Includes: * Base COPAS system with PC & software * 250 micron flow cell * 40 ml sample cup * X-Y stage allows dispensing into 24, 48, 96 or 384-well microtiter plates. * Full one-year warranty from date of installation. * Installation by factory trained Engineer and on-site operator training by one of our Applications Scientists. CLIN 0002488nm Solid State Laser Option 550-7301-000; QUANTITY ONE (1) EA Solid State 488nm Laser Assembly: includes Laser, Laser Electronics, Fiber Optic Cable & Optics Assembly: The 488 SS laser can be used to measure the axial length, optical density and can also be used to excite fluorescence in the green & yellow parts of the spectrum. This laser is especially recommended when looking at small objects (<~40 microns), when you want the flexibility to add a second laser such as a 405nm or a 561nm to the system, and when using Advanced Acquisition or Profiler Software. This laser has an output power of 20mW and will operate for 10,000 hours with proper use and maintenance. CLIN 0003Sample Recovery 344-5001-000; QUANTITY ONE (1) EA Sample Recovery Module Option for the COPAS Select / Plus / XL: Includes additional tubing and removable recovery container for gentle sample recovery. CLIN 0004Advanced Acquisition Package 380-5000-200; QUANTITY ONE (1) EA Advanced Acquisition Package Option includes advanced electronics and enhanced software analytical tools that permit significantly higher data resolution, object flow, and acquisition rates. Higher signal resolution is achieved with 16-bit data resolution to offer 32 times more detail in intensity and size (than the standard software) and the ability to detect smaller objects, distinguish better than 5 micron size differences, and detect lower intensity fluorescent signals. The increased object acquisition rate permits the sample to be run four times faster than standard rates. Additional software features include: improved data displays such as linear and logarithmic scaling; extended sorting capabilities; fluorescence compensation for increased fluorescence discrimination; and user-defined math functions for advanced real-time data manipulation. Expanded data storage capabilities fully compatible with FCS 2.0 standard. * This option includes both hardware and software upgrades. CLIN 0005Profiler II Software Package 380-5000-300; QUANTITY ONE (1) EA Profiler II Option (requires Advanced Acquisition Package) simultaneously detects and records up to 8,000 data points per object for each of the four optical parameters: extinction and three fluorescence channels. Profiler II digitizes the object into a succession of peaks and valleys that directly trace the fluorescence intensity of an object as it passes through the flow cell, resulting in an optical profile of each object, graphically showing the location and intensity of all four optical parameters. Advanced imaging graphically and numerically displays subtle variations in fluorescence and extinction intensity along the length of an object. Instrument sorting capabilities are extended with user definable sort criteria for profile peak heights, widths, locations, and number for each optical parameter. CLIN 0006Accessory Pack (110V) 3XX-5098-000; QUANTITY ONE (1) EA Contains control particles, cleaning solution, sheath reagent, tubing, fittings, power cords, and all bottle assemblies. Part number specific to instrument type. For AC 110 volt countries. 1 Included CLIN 0007Air Compressor (120V) 300-7000-001; QUANTITY ONE (1) EA Laboratory grade, low noise, self-contained, oil type air compressor capable of delivering stable pressure to the system. CLIN 0008Warranty; QUANTITY ONE (1) EA The offeror shall provide a firm fixed price for warranty and support for the equipment quoted. The support price should be quoted for a one (1) year period of performance. (vii) Date(s) and place(s) of delivery and acceptance and FOB point: Please provide a date in which the items can be delivered. (viii) Provision at 52.212-1, Instructions to Offerors—Commercial, applies to this acquisition and a statement regarding any addenda to the provision. (ix) 52.212-2 Evaluation—Commercial Items. As prescribed in 12.301(c), the Contracting Officer may insert a provision substantially as follows: EVALUATION—COMMERCIAL ITEMS (JAN 1999) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The factors below shall be used to evaluate offers. a.Technical capability of the item offered to meet the Government requirement: Technical capability is being evaluated by how well the proposed products meet the following Government requirements: 1. The large flow cell design permits handling various types of “large” objects (20 – 1,500 microns) as opposed to traditional flow cytometry instruments which are designed / used for sorting single cells. Four flow cell sizes are sold as four individual platforms optimized to accommodate a specific subset of the size object range. The flow cell design and sizes are unique to Union Biometrica, Inc. 2. The fluidics and optical assembly design are optimized for use with the large, fragile objects. Operating at lower pressures than standard flow cytometers, the system passes objects through the flow cell at a slower rate of speed to achieve high measurement accuracy and sensitivity while being gentle enough to maintain viability of these organisms/fragile objects. These features are unique to Union Biometrica, Inc. instruments. 3. A patented gentle airflow sorting mechanism utilizing an “air jet diverter valve” allows for the collection of live biological materials. This gentle, non-destructive air sorting method is used to divert non-selected objects to a waste tray. If an object is identified as fitting the set criteria, the airflow is paused briefly, allowing that specimen to drop into either bulk collection or a microtiter plate, completely viable, unharmed, and unchanged. In comparison, traditional flow cytometers typically use a large electrostatic charge to affect sorting. Such a charge works fine for cell sorters where samples are simply analyzed & discarded, but would be disruptive to live organisms/cell clusters such as those identified above. This diverter feature is unique to Union Biometrica and covered by patents 6,657,713 and 6,400,453. 4. Profiler II Option: This axial profiling option provides simultaneous recording of four optical parameters (three of fluorescence and one of extinction) and collects up to 8000 points of data per object per channel recorded along the object’s axial length, thereby “electronically slicing” objects passing through the flow cell. Whereas basic flow cytometers simply identify whether an object does/does not contain a fluorescent label, Profiler II elucidates the exact location of the marker within the object/organism. Profiler II offers extended sorting abilities with user definable sorting regions including profile peak heights, widths, locations, and numbers for each channel. This axial profiling feature is unique to Union Biometrica and covered by patent 7,116,407 B2. b. Past performance Past Performance Contractors shall submit one (1) reference contract /purchase order. The contract/purchase order listed may include those entered into by the Federal Government, agencies of State and local governments and commercial customers. Contractors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. The reference list of one (1) reference shall include the following information for each contract and subcontract: 1.Name of contracting activity 2.Contract number 3.Contract type 4.Total contract value 5.Contract work 6.Contracting officer and telephone 7.Program manager and telephone 8.Administrative contracting officer, if different from #6, and telephone c. price (b) Technical and past performance when combined is significantly more important than price. The government is more concerned with obtaining performance capability superiority rather than lowest overall cost. Offerors are advised that award will be made to the offeror whose quotation provides the combination of services that offers the best value to the Government. (c ) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (x) Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Items, with its offer. (xi) The clause at 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. (xii) Clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. (xiii) A statement regarding any additional contract requirement(s) or terms and conditions (such as contract financing arrangements or warranty requirements) determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices All interested offerors must be registered in the Central Contractor Registration (CCR). Award will be made to the party whose quote offers the best value to the Government, technical, past performance and price and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13 Simplified Acquisition Procedures. The due date for questions is July 29, 2009. The due date for quotes is August 7, 2009 by 4:30pm EST and shall be submitted electronically to Dominique.Malone@fda.hhs.gov. An award will be made shortly thereafter. Please email all quotes and inquiries to Dominique Malone at Dominique.Malone@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-09-1058963/listing.html)
- Place of Performance
- Address: MOD1 RM1412 HFS-025, 8301 Muirkirk Road, Laurel, Maryland, 20708, United States
- Zip Code: 20708
- Zip Code: 20708
- Record
- SN01885365-W 20090725/090724000351-143b553558989d17982ad2f8c44de7af (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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