This is a sources sought to determine the availability and capability of small and large businesses in providing a DNA Library Preparation System with inside delivery, installation, Installation Qualification (IQ), Operational Qualification (IQ) and Performance Qualification (PQ), training, and up to four (4) 1-Year periods for post warranty Preventive and Corrective Maintenance. 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), Office for Regulatory Affairs (ORA) Office of Regulatory Science conducts research entailing the identification of microorganisms at the genetic level using a Illumina MiSeq system for Whole Genome Sequencing System. To ensure consistently reliable DNA extraction for microbial identification and eliminate human error due to differences in analyst technique, ORA requires the use of an automated DNA library preparation system for use in conjunction with existing Illumnia MiSeq sequencing instruments. The systems will be used for extraction of DNA for use in quantitative polymerase chain reaction whole genome sequencing, and for a variety of established nucleic acid extraction protocols to ultimately genetically identify organisms isolated from regulatory samples and

Part II: Work Requirements

A. DNA Library Preparation System
At a minimum the contractor will be required to provide:

Four (4) DNA Library Preparation Systems compatible with Illumina next-generation sequencing platforms; existing equipment includes Illumina MiSeq Sequencing System (serial numbers: M01444, M01449, M01599R, M01404).
• Maximum 115V, 50Hz
• Windows 7 compatible control computer, with minimum 16GB storage capacity, and preinstalled software
• User friendly operation
• Operating temperature range of 19°C to 25°C
• 2D barcode scanner
• Minimum 16 libraries per run
• Minimum of 5 Library preparation kits for each laboratory location inclusive of assays and reagents for DNA and RNA sequencing

B. Inside Delivery, Installation, IQ/OQ/PQ, and Training
At a minimum the contractor will be required to provide:

• Inside delivery, installation, and clean-up of the installation site with documented Installation Qualification, Operational Qualification, and Performance Qualification.

• On-site training for system operators at the time of installation. Training shall include but not be limited to system operations (inclusive of hardware and software), quality control, instrument programming, diagnosing instrument problems, basic and routine preventative maintenance procedures, cleaning requirements, troubleshooting, and system maintenance.

D. Minimum Service Requirements
I. Warranty
At a minimum the contractor will be required to 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. Post-Warranty System Service Plan: Preventive Maintenance/Corrective
Maintenance Service
At a minimum, the Contractor will be required to 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 will be required to provide:
• Turn-key solution which shall include, but not be limited to: all hardware, software, components, connectors, interfaces, instruments, kits, and on-site familiarization, required to meet the specifications and the FDA's stated need and intended use for the system.

Part III: Supporting Information

A. Place of Performance
Inside delivery, installation, IQ/OQ/PQ, and training shall occur at the following FDA/ORA Laboratory locations:

U.S. Food and Drug Administration
ORA Pacific Regional Lab-South West
19701 Fairchild
Irvine, CA 92612-2506

U.S. Food and Drug Administration
ORA Pacific Regional Laboratory-North West
22201 23rd Drive, SE
Bothell, WA 98021

U.S. Food and Drug Administration
ORA San Francisco Laboratory
1431 Harbor Bay Pkwy
Alameda, CA 94502

U.S. Food and Drug Administration

ORA Southeast Regional Laboratory
60 Eighth Street NE
Atlanta, GA 30309

 
B. Period of Performance
Inside delivery, installation, IQ/OQ/PQ, and training shall occur within 90 calendar days (or less) from date of award.

Part IV: Instructions to Prospective Respondents

Respondents shall furnish sufficient information necessary for the Government to fully understand the capabilities of their DNA Library Preparation System(s) and associated services as it relates to the requirements and intended use set forth 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;

~Descriptive literature, brochures, specifications, marketing material, etc. that clearly detail the dimensions, attributes, specifications, capabilities, and user maintenance requirements of/for the respondent's DNA Library Preparation System(s) and associated services as it relates to the requirements and intended use set forth herein AND site preparation requirements necessary for the installation and operation of the respondent's DNA Library Preparation System(s);

~Prior experience/usage information for same or near same use of the respondent's DNA Library Preparation System(s) and associated services to include the DNA Library Preparation System(s) configuration, description of application(s) for which the DNA Library Preparation System(s) was used, 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;

~Identify any issues or concerns with the requirements as currently stated to include any additional information that may be desired when the solicitation is ultimately released;

~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 the information required herein, which is due in person, by postal mail or email to the point of contact listed below on or before April 16, 2015 by 9:00 AM (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 [email protected]. Reference Number 1146757 in all correspondence with the point of contact listed above.

Notice of Intent
Responses to this sources sought announcement will assist the Government in better understanding the capabilities of DNA Library Preparation Systems as it relates to the requirements and intended use set forth herein, assist in better defining the Government's requirements for DNA Library Preparation Systems and associated services in terms that would promote competition without negatively impacting the intended use set forth herein, and 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 solicitation (No. FDA-15-223-SOL-1146757) 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).