SOURCES SOUGHT
66 -- High Performance Liquid Chromatography (HPLC) Triple Quadrupole Mass Spectrometer System
- Notice Date
- 4/4/2017
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1179740
- Archive Date
- 4/26/2017
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for a High Performance Liquid Chromatography (HPLC) Triple Quadrupole Mass Spectrometer System and Components and Post Warranty Service/Maintenance Option Periods. This is a Sources Sought Notice to determine the availability and capability of Small Business Manufacturers or Small Businesses capable of supplying a U.S. made product of a small business manufacturer or producer. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The appropriate NAICS code for this acquisition is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. Statement of Work (SOW) Background/Objective The U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA) Arkansas Regional Laboratory (ARL) has a requirement for a High Performance Liquid Chromatography (HPLC) Triple Quadrupole Mass Spectrometer System. The instrument will be used for high throughput multi-drug residue screening in honey by directly coupling it to an existing RapidFire 365 Automated Solid-Phase Extraction System manufactured by Agilent Technologies, Inc., Serial Number SG15350004. Also, the instrument will be utilized for quantitation and confirmation of chloramphenicol in aquaculture products (via LC/MS). General Specification: The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. Technical Requirements: The HPLC system shall meet the following: 1. The system shall be able to connect to an existing RapidFire 365 system. The HPLC components shall be capable of high throughput analysis incorporating two HPLC columns, the autosampler shall be capable of containing large quantities of sample vials, and the mass spectrometer shall incorporate both an atmospheric pressure chemical ionization (APCI) and electrospray ionization (ESI). 2. Systems shall include an HPLC system interfaced to a triple quadrupole mass spectrometer system for highly sensitive and selective quantitative and qualitative analysis of chemical residues in foods, dietary supplements, and drugs. 3. The system shall be able to accommodate at least 500 scheduled multiple reaction monitoring (MRM) scans per analytical method for multi-residue analysis. 4. The system shall include an integral divert valve which allows effluent to travel to either the mass spectrometer or waste. This divert valve shall be programmable from the software during an analysis. 5. The system shall allow the acquisition of MS scans, MS/MS product ion scans, multiple reaction monitoring (MRM) scans, simulated ion monitoring (SIM) scans, time dependent multiple reaction monitoring, and signal intensity dependent scans. 6. The system shall include a complete workstation for instrument control, data acquisition, and data analysis system including computer, monitor, and printer. There shall be two licenses for the data analysis software. The HPLC shall be controllable using the same hardware and software system. 7. The software shall be capable of producing reports, which can be exported to word, PDF and excel, with the following information: • extracted chromatograms of analytes of interest • sample name and type • vial location • acquisition date and time • injection volume • calculated and expected concentrations • product ion area counts for all MRM transitions (sorted by compound) • retention time • calculated ion ratio data (product/product) • calibration curves (including fit method and any weighting), 8. The HPLC system shall include 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). 9. The HPLC system shall be equipped with a binary solvent pump. The pump shall have an option for a solvent selection valve, which would allow the binary mixture from four independent solvent sources. The solvent selection values shall be controllable from the operations software. 10. The HPLC pumps shall have a flow rate range of at least 0.10 - 3 mL/minute and shall be able to achieve a maximum pressure of 600 bar or greater. The pumps shall have a delay volume of 120 microliters or less. 11. The HPLC system shall be equipped with appropriate 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 3 milliliters per minute. 12. The HPLC system shall be equipped with an autosampler for unattended continuous operation. The autosampler shall be capable of operating with standard 2 milliliter autosampler vials as well as with well-plate trays. The autosampler shall be capable of selectable injection volumes between 0.1 - 40 microliters. The autosampler shall have a minimum capacity of 100 vials (2mL) and be able to achieve a maximum pressure of 600 bar. 13. The HPLC autosampler shall be temperature controlled over at least a temperature range from 4 degrees C to 40 degrees C. 14. The autosampler shall have the ability to perform vial/well bottom sensing (or equivalent) within 2 mL sample vials are needed, as the available sample volume can vary with the application. 15. The HPLC system shall be 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 shall be able to accommodate columns up to 4.6 mm in diameter and up to 300 mm in length so as to be able to run legacy methods. 16. The ionization source shall be heated to accommodate HPLC flow rates of ≥750 µL. 17. The HPLC portion of the system shall be compatible (controllable) using the mass spectrometer's software so that analysis is automatically coordinated. 18. The HPLC system shall be equipped with a column switching valve which can be controlled by the system software and can withstand 600 bar of pressure or more. Installation, Training, and Additional System Requirements The contractor shall provide delivery, on-site (Government-site) operator familiarization training for the system upon completion of installation. Such familiarization shall include system operations, optimization, and basic preventive maintenance procedures. The contractor shall include all parts, travel, and labor to complete installation. Installation shall be performed and completed during normal duty hours (Monday through Friday, 8:00 AM to 4:30 PM, Central Time). Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, printers, software, and that otherwise required to meet these specifications and the FDA's stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The contractor shall provide all components, equipment, software, and/or other needed items to connect to the existing RapidFire 365 system. The contractor shall demonstrate upon installation that the item meets all performance specifications, including the mass spectrometer sensitivity specification. The instrument shall not be accepted until those performance specifications have been met. The entire system shall be warranted for parts and labor for a minimum of 12 months from date of installation acceptance. The warranty shall include unlimited telephone/e-mail support for questions regarding operation. The contractor shall provide three (3) days of on-site training for the system at the specified delivery location for up to 3 individuals. Installation and operator training for at least one operator at the contractor's training facility shall be included. Optional Line Items: Four (4) 1-Year Post-Warranty Option Periods for a Service/Maintenance Agreement on the system shall include, at a minimum, the following: 1. Shall include a minimum of one (1) planned preventative maintenance visit per contract year. 2. Shall include unlimited corrective/remedial maintenance repair visits. 3. Unlimited corrective/remedial maintenance, service, and repairs shall include all labor, travel, and parts (except consumables). A service engineer shall be able to work on-site within three business days of call for service. Provide service response time with quote. 4. All maintenance work shall be performed on-site (Government-site). 5. Shall include unlimited software and firmware updates. 6. Shall include trouble-shooting capabilities based on complete knowledge of the entire system. 7. All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using the OEM replacement parts, components, subassemblies, etc. 8. Access by the FDA system operator personnel to the maunfacturers call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for trouble-shooting the instrument. 9. Access by the FDA system operator personnel to the manufacturer's latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. 10. All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. 11. Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. Contract Type: Commercial Item-Firm Fixed Price FOB Point Destination. Delivery, installation, and on-site training shall be not later than 90 calendar days after award. Delivery for Services and Supplies shall be made to the following address: U.S. Food and Drug Administration Jefferson Laboratory Complex Arkansas Regional Laboratory 3900 NCTR Road, Building 26 Jefferson, AR 72079 POC: Will be provided at time of award The respondent to this source sought shall furnish sufficient technical information necessary for the Government to conclusively determine its capability to provide products/services and components meeting the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying U.S. made system of another small business manufacturer or producer, all interested parties may respond. At a minimum, responses shall include the following: Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); Sufficient descriptive literature that unequivocally demonstrates that offered products and services meet or exceed above specifications. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items to include date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. The government is not responsible for locating or securing any information, not identified in the response. Interested parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before April 11, 2017 by 12:00 PM (Central Time in Jefferson, Arkansas) at the FDA/OO/OFBA/OAGS/DAP, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1179740. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)
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