SOURCES SOUGHT
66 -- Clinical Chemistry Analyzer System - Sources Sought 1144788
- Notice Date
- 2/10/2015
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1144788
- Archive Date
- 3/12/2015
- Point of Contact
- Sondea R Blair, Phone: 8705437469
- E-Mail Address
-
sondea.blair@fda.hhs.gov
(sondea.blair@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought 1144788.pdf MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small businesses in providing a Clinical Chemistry Analyzer System with training, and up to four (4) 1-Year periods for post warranty Preventive and Corrective Maintenance Services. The associated North American Industry Classification System (NAICS) Code is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Clinical Pathology serves NCTR investigators by providing micro sample size, multi-species testing for clinical chemistry assays in accordance with National Toxicology Program's (NTP) specification of conduct of studies and the Organization for Economic Co-operation and Development (OECD) inhalation studies. The Clinical Chemistry Analyzer System will be used to perform assays on biological samples including: serum, plasma, urine, fluids, and extracts. Part II: Work Requirements A. Clinical Chemistry Analyzer System At a minimum the contractor shall provide: •Benchtop chemistry analyzer with footprint no larger than 36X30X30 (HLD in inches) •Open reagent system allowing for customization of testing capacity and the use of reagents from multiple manufactures as well as non-instrument manufacture reagents inclusive of but not limited to Bile Acids and Sorbitol Dehydrogenase as required by NTP. •Refrigerated onboard reagents •Ion-specific electrode (ISE) module for Sodium (Na), Potassium (K), and Chloride (Cl) •System with capacity for multiple assay types and methods •System with capability for statim (STAT) testing •Automatic sample dilution and rerun •System capable of defining multiple test panels •System with capability to set reference ranges for up to 10 species •Closed tube sampling system •System with ability to read bar codes •Information system software with the capability to interface with other instruments from any supplier to include but not limited to the Horiba ABX Pentra 60C+ (serial number 109PCP10710) that will allow for the integration of results into a single report •Software that has the capability of data mining the integrated results to produce different reports specific for the project •Software that is capable of managing all interfaced instruments from one workstation. •Software with capability to customize screen input. i.e. ‘study number', name etc. B. Training At a minimum the contractor shall provide: •On-site training for up to four operators including but not limited to system operations (inclusive of hardware and software), quality control, instrument programming, diagnosing chemistry and instrument problems, basic and routine preventative maintenance procedures, cleaning requirements, troubleshooting, and system maintenance. C. Minimum Service Requirements I. Warranty At a minimum the contractor shall provide: •Minimum 12-month warranty on the entire system, inclusive of hardware and software components. •Warranty shall be inclusive of parts, labor, and travel expense to commence upon completion and acceptance of system and training. II. System Service Plan: Preventive Maintenance/Corrective Maintenance Service At a minimum, the Contractor shall provide: •One (1) scheduled preventive maintenance visit annually inclusive of parts, travel, and labor expense •Include unlimited corrective/remedial maintenance visits within 3 business days of call for service •Include unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Central Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) •Include unlimited software and firmware updates •All maintenance and repair activities shall be performed by trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. •Access for the FDA Contracting Officer's Representative (COR) and system operator personnel 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 •Services inclusive of labor, travel, replacement parts, components, subassemblies, etc. D. Turnkey System At a minimum, the Contractor shall provide: •Turn-key solution which shall include, but not be limited to: all hardware, software, components, connectors, interfaces, instruments, supplies, kits, on-site familiarization and operation training, required to meet these specifications and the FDA's stated need and intended use for the system. Part III: Supporting Information A. Place of Performance U.S. Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079 B. Period of Performance System delivery, installation, and training shall be completed within 120 calendar days (or sooner) from date of award. Part IV: Instructions to Prospective Respondents The offeror shall furnish sufficient information necessary for the Government to conclusively determine that the respondent is capable and otherwise qualified to perform the full range of services identified herein. At a minimum, responses shall include the following: ~Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; ~Past performance information for the Chemistry Analyzer System and preventive and corrective maintenance services identified herein, for the same or substantially similar OEM equipment, to include date of services, description (should also include technical literature and specifications), 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; ~Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing; ~If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; ~Although this is not a request for quote, informational pricing is encouraged; The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested parties must respond with capability statements, which are due in person, by postal mail or email to the point of contact listed below on or before February 25, 2015 by 2:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, Bldg 50/Room 421, HFT‐320, Jefferson, AR 72079‐9502 or email sondea.blair@fda.hhs.gov. Reference Number 1144788 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures. 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 combined synopsis/solicitation (No. FDA-15-223-SOL-1144788) may be published via FedBizOpps. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1144788/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03638779-W 20150212/150210235243-380125d8ee6883d8d532e1999b45493f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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