SOURCES SOUGHT
66 -- Four (4) LC-Triple Quadrupole / Ion Trap Mass Spectrometers for four FDA Labs. - RFI document
- Notice Date
- 11/26/2010
- Notice Type
- Sources Sought
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus 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
- RFI-1081941
- Archive Date
- 12/18/2010
- Point of Contact
- Ariana Nijaradze, Phone: 3018277161
- E-Mail Address
-
ariana.nijaradze@fda.hhs.gov
(ariana.nijaradze@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Attached is the complete RFI document. General Information: Document Type: Request for Information (RFI) Document Number: RFI-1081941 Release Date: November 26, 2010 Response Date: December 3, 2010 at 4:30pm EST via e-mail to Contracting Specialist Contracting Office Address: Food and Drug Administration (FDA), Ariana Nijaradze Ariana.Nijaradze@fda.hhs.gov Contract Specialist Description: Four (4) LC-Triple Quadrupole / Ion Trap Mass Spectrometers for four FDA Labs. This is a Request for Information (RFI) to identify the capabilities of the marketplace of all interested parties. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. According to FAR Part 10, Market Research, the results of the market research will be used to: i) Determine if sources capable of satisfying the agency's requirements exist; (ii) Determine if commercial items or, to the extent commercial items suitable to meet the agency's needs are not available, nondevelopmental items are available that- (A) Meet the agency's requirements; (B) Could be modified to meet the agency's requirements; or (C) Could meet the agency's requirements if those requirements were modified to a reasonable extent; (iii) Determine the extent to which commercial items or nondevelopmental items could be incorporated at the component level; (iv) Determine the practices of firms engaged in producing, distributing, and supporting commercial items, such as type of contract, terms for warranties, buyer financing, maintenance and packaging, and marking; (v) Ensure maximum practicable use of recovered materials and promote energy conservation and efficiency; and (vi) Determine whether bundling is necessary and justified. (vii) Assess the availability of electronic and information technology that meets all or part of the applicable accessibility standards issued by the Architectural and Transportation Barriers Compliance Board at 36 CFR Part 1194. The extent of market research will vary, depending on such factors as urgency, estimated dollar value, complexity, and past experience. The contracting officer may use market research conducted within 18 months before the award of any task or delivery order if the information is still current, accurate, and relevant. Market research involves obtaining information specific to the item being acquired and should include- (i) Whether the Government's needs can be met by- (A) Items of a type customarily available in the commercial marketplace; (B) Items of a type customarily available in the commercial marketplace with modifications; or (C) Items used exclusively for governmental purposes; (ii) Customary practices regarding customizing, modifying or tailoring of items to meet customer needs and associated costs; (iii) Customary practices, including warranty, buyer financing, discounts, contract type considering the nature and risk associated with the requirement, etc., under which commercial sales of the products or services are made; (iv) The requirements of any laws and regulations unique to the item being acquired; (v) The availability of items that contain recovered materials and items that are energy efficient; (vi) The distribution and support capabilities of potential suppliers, including alternative arrangements and cost estimates; and (vii) Size and status of potential sources. Mission and Objectives: HPLC-Triple Quadrupole Mass Spectrometers with ion trap capability are needed at the Arkansas Regional Laboratory (ARL), the San Francisco District Laboratory (SAN-LAB), the Kansas District Laboratory (KAN-LAB), and the Southeast Regional Laboratory (SRL). The units at ARL and SRL will be used for screening and low level determinations of chemotherapeutic agents in foods. The unit at KAN-LAB will have immediate use in determination of Polynuclear Aromatic Hydrocarbons (PAH) and chemotherapeutics in FDA regulated seafood products. KAN-LAB also intends to use this equipment to analyze steroids in dietary supplements. The unit at SAN-LAB will be used in a variety of applications from pesticides, PAH, terror agent screening, and chemotherapeutics screening. Additionally the HPLC components of the ARL and SRL instruments need to be capable of high throughput analysis incorporating two HPLC columns which are alternately regenerated such that the duty cycle of the mass spectrometer is effectively doubled. The mass spectrometers for the KAN-LAB and SAN-LAB shall have an added Atmospheric Pressure Photoionization interface to detect PAHs. To accommodate fast separations, the Mass Spectrometers must be able to scan rapidly and switch polarity rapidly. RFI Instructions: Please complete Part A, Specification Questionnaire, describing your company's capabilities; Part B, Size of Business and Part C, Estimated Dollar Value Range. Responses shall be:  identified with the RFI number ;  no more than ten (10) pages in length;  not submit marketing materials;  submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Part A. Technical Capability Specification Questionnaire: Is your company capable of providing four (4) new HPLC-Triple Quadrupole Mass Spectrometers with ion trap capability? Does your system contain the following specifications common to all four systems? An HPLC system interfaced to a triple quadrupole/ion trap mass spectrometer system for highly sensitive and selective quantitative and qualitative analysis of chemical residues in foods, dietary supplements, cosmetics, and drugs? A complete workstation for instrument control, data acquisition, and data analysis system including computer and monitor. There shall be two licenses for the data analysis software. The HPLCs shall be controllable using the same system? Able to trap ions for MSn analysis during the same run as it performs triple quadrupole analyses? Able to switch polarity in ESI mode in 60 milliseconds or less to facilitate rapid multiresidue analysis? Able to accommodate at least 500 scheduled MRMs per analytical method for multiresidue analysis? Minimum MRM dwell time are no more than 2 milliseconds? Mass ranges are up to 1000 m/z or higher? Capable of Electrospray Ionization (ESI) and Atmospheric Pressure Chemical Ionization (APCI)? The ionization source is heated to accommodate high HPLC flow rates? The system have a demonstrated a sensitivity for 1 picogram reserpine using a non-ion trap mode with a S/N of >= 1000:1? The HPLC portion of the systems are compatible (controllable) of using the mass spectrometer's software so that analysis is automatically coordinated? For the system to be delivered to KAN-LAB, Lenexa, KS, does your system also contain the following specifications? An Atmospheric Pressure Photoionization source (APPI) for the analysis of nonpolar molecules? A gas generator capable of supplying sufficient dry and pure nitrogen for the system to operate under all nitrogen flow conditions? The gas generator is also capable of generating zero air and dry air? The gas generator contains its own air compressor and can be wired to run from standard 120 VAC power? The HPLC portion of the system is pressure rated up to at least 630 bar? The HPLC contains three isocratic solvent pumps? The HPLC includes a mixing chamber constructed of stainless steel? The HPLC portion includes at least three channels of degassing? The HPLC includes a versatile autosampler which can accommodate several different vial sizes, well plate formats, and be temperature controlled over at least a temperature range from 4 degrees C to 35 degrees C? The HPLC column compartment is temperature controlled from 10 degrees C below ambient temperature to at least 80 C? The column compartment is able to accommodate at least 2 switching valves? The HPLC system contains provisions for at least 5 solvent bottles? The HPLC system contains its various components networked and data buffered? The HPLC system contains a solvent switching unit for supplying the three pumps? For the system to be delivered to SAN-LAB, Alameda, CA, does your system also contain the following specifications? A gas generator capable of supplying sufficient dry and pure nitrogen for the system to operate under all nitrogen flow conditions? The gas generator is also capable of generating zero air and dry air? The gas generator contains its own air compressor and be wired to run from standard 120 VAC power? A screening method, HPLC columns, and MRM library for at least 500 pesticides? A screening method, HPLC column, and MRM library for at least 1000 drugs of abuse? An LC/MS/MS library containing at least 1500 compounds of interest to forensics? A suitable instrument bench designed to support the system and to provide some noise reduction? A bench extension to support the HPLC components? Can provide at least 4 days of onsite consultation? An Atmospheric Pressure Photoionization source (APPI) for the analysis of nonpolar molecules? The HPLC portion of the system can be pressure rated up to at least 630 bar? The HPLC consists of three isocratic solvent pumps? The HPLC includes a mixing chamber constructed of stainless steel? The HPLC portion includes at least three channels of degassing? The HPLC includes a versatile autosampler which can accommodate several different vial sizes, well plate formats, and be temperature controlled over at least a temperature range from 4 degrees C to 35 degrees C? The HPLC column compartment can be temperature controlled from 10 degrees C below ambient temperature to at least 80 C? The column compartment is able to accommodate at least 2 switching valves? The HPLC system contains provisions for at least 5 solvent bottles? The HPLC system contains its various components networked and data buffered? The HPLC system contains a solvent switching unit for supplying the three pumps? For the system to be delivered to ARL, Jefferson, AR, does your system also contain the following specifications? The HPLC portion of the system is capable of running two HPLC columns continuously such that analysis is occurring on one column and forwarded for mass spectrometry while the second column is being washed? The HPLC system includes an operator interface which may be used to control the HPLC portion of the instrument independently of the mass spectrometer (for purposes of troubleshooting, maintenance, and flexibility of operation of the HPLC)? The HPLC system is equipped with two binary solvent pumps? The HPLC pumps shall have a flow rate range of at least 0.10 - 5 mL/minute and shall be able to achieve a maximum pressure of 600 bar. The pumps shall have a delay volume of 120 microliters or less. The HPLC pumps include software controllable solvent selection valves to enhance the flexibility of the system? The HPLC system is equipped with two degasser modules which are capable of simultaneously degassing solvents from at least a total of 4 different reservoirs with a flow rate of up to 5 milliliters per minute? The HPLC system is equipped with an autosampler for unattended continuous operation. The autosampler should be capable of operating with standard 2 milliliter autosampler vials as well as with well-plate trays. The autosampler is capable of selectable injection volumes between 0.1 - 90 microliters? The HPLC autosampler is temperature controlled over at least a temperature range from 4 degrees C to 40 degrees C? The HPLC system is equipped with a temperature controlled column compartment which is capable of maintaining the columns at a steady temperature from at least 10 degrees centigrade below room temperature up to 70 degrees centigrade? This compartment is able to accommodate columns up to 4.6 mm in diameter and up to 300 mm in length? The HPLC system is equipped with a 10-port column switching valve which can be controlled by the system software? The HPLC modules are able to communicate with each other through a network? For the system to be delivered to SRL, Atlanta, GA, does your system also contain the following specifications? The HPLC portion of the system is capable of running two HPLC columns continuously such that analysis is occurring on one column and forwarded for mass spectrometry while the second column is being washed? The HPLC system includes an operator interface which may be used to control the HPLC portion of the instrument independently of the mass spectrometer (for purposes of troubleshooting, maintenance, and flexibility of operation of the HPLC)? The HPLC system is equipped with two binary solvent pumps? The HPLC pumps have a flow rate range of at least 0.10 - 5 mL/minute and are able to achieve a maximum pressure of 600 bar? The pumps have a delay volume of 120 microliters or less? The HPLC pumps include software controllable solvent selection valves to enhance the flexibility of the system? The HPLC system is equipped with two degasser modules which are capable of simultaneously degassing solvents from at least a total of 4 different reservoirs with a flow rate of up to 5 milliliters per minute? The HPLC system is equipped with an autosampler for unattended continuous operation? The autosampler is capable of operating with standard 2 milliliter autosampler vials as well as with well-plate trays? The autosampler is capable of selectable injection volumes between 0.1 - 90 microliters? The HPLC autosampler can be temperature controlled over at least a temperature range from 4 degrees C to 40 degrees C? The HPLC system is equipped with a temperature controlled column compartment which is capable of maintaining the columns at a steady temperature from at least 10 degrees centigrade below room temperature up to 70 degrees centigrade? This compartment is able to accommodate columns up to 4.6 mm in diameter and up to 300 mm in length? The HPLC system is equipped with a 10-port column switching valve which can be controlled by the system software? The HPLC modules are able to communicate with each other through a network? The system includes a gas generator capable of supplying sufficient dry and pure nitrogen for the system to operate under all nitrogen flow conditions? The gas generator is also capable of generating zero air and dry air? The gas generator contains its own air compressor and be wired to run from standard 120 VAC power? Can your company provide warranty for the entire systems for parts and labor for 12 months from date of installation? Can your company provide installation and operator training for at least one operator at the vendor's training facility for each system? For SAN-LAB: Can your company provide at least 4 days of onsite consultation? Can your company provide training for two additional analysts at the vendor's training facility which shall include qualitative and quantitative analysis using the equipment? For ARL: Can your company provide training for two additional analysts at the vendor's training facility which shall include qualitative and quantitative analysis using the equipment? For KAN: Can your company provide training for one additional analyst at the vendor's training facility which shall include qualitative and quantitative analysis using the equipment? For SRL: Can your company provide training for one additional analyst at the vendor's training facility which shall include qualitative and quantitative analysis using the equipment? Can your company provide optional extended warranty/maintenance agreements for four years? Can your company's maintenance agreements meet the following specifications? Include trouble-shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer? Service can be provided by service engineers who are trained and certified by the original manufacturer? Engineers can have access to the manufacturer's latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures? Can enable the instrument operators to have access to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument? Guarantee that a service engineer will be able to work on site within three business days of notification? Can provide all travel, labor and parts at no additional charge? Can there be at least one (1) scheduled maintenance visit per year of the contract? Can also include coverage for software and firmware updates? Part B. Size of Business State whether your company is a large business, small business (and also state your under socioeconomic status), College/University, or a non-profit organization. Part C. Estimated Dollar Value Range Based on the government's mission, objectives, and scope of work, what dollar value range would you determine to be the most accurate rough estimate. Under $2,000,0000.00 Over $2,000,000.00 and Under $2,500,000.00 Over $2,500,000.00
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