Request for Information (RFI) New Microbiology Screening Technology
AMENDMENT #4:
The purpose of Amendment #4 is to extend the submission deadline. All RFI/capability statements must be submitted electronically no later than 3:00 PM EST on Wednesday, March 15, 2017.
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AMENDMENT #3:
The purpose of Amendment #3 is to incorporate the response to Q3 to the Response to Vendor Inquiries.
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AMENDMENT #2:
The purpose of AMENDMENT #2 is to provide the Response to Vendor Inquiries.
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AMENDMENT #1:
The purpose of AMENDMENT #1 is to re-attach Attachment A and the RFI pdf.
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THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research.
PLEASE NOTE THAT THIS IS NOT A REQUEST FOR QUOTE (RFQ). NO SOLICITATION EXISTS AT THIS TIME. This RFI is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for Market Survey and project planning purposes and to identify potential sources that may be interested in and capable of performing the work described, and to solicit industry feedback relative to various aspects of the proposed contract effort. The purpose of this notice is to also obtain information regarding: (1) the availability and technical capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service- disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The North American Industry Classification System (NAICS) Code is 325414-Biological Product (except Diagnostic) Manufacturing with a small business size standard of 1,250 employees.
Background
The United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) is hereby requesting information about potential sources capable of providing the agency with a rapid, high throughput, single or multi-analyte test system to detect or identify, or detect or identify and enumerate bacterial pathogens including, but not limited to Salmonella, E.coli O157:H7, Non-O157 STEC, Listeria monocytogenes, and Campylobacter. The system will be used to detect bacteria pathogens in food products and food producing environments that are regulated under the Poultry Inspection Act (PIA), Egg Products Inspection Act (EPIA), and the Federal Meat Inspection Act (FMIA), including Siluriformes (fish) as added under the 2008 and 2014 Farm Bills. The system will need to have demonstrated the capability to perform with the sample matrices encompassed under these Acts. In fiscal year 2016, FSIS performed approximately 500,000 tests for pathogenic bacteria.
Description of Requirement
The test system shall detect bacterial pathogens in all FSIS regulated products; raw meat and poultry; ready to eat (RTE) meat and poultry; processed egg products; raw and RTE Siluriformes; carcass rinses; and carcass and environmental swab samples, and all other matrices described in the USDA FSIS Microbiology Laboratory Guidebook (MLG) or falling under the authorities provided in the PIA, EPIA, and FMIA or other promulgated authorities of FSIS. The test system shall be able to detect bacterial pathogens that may be sub lethally injured. The test system shall be able to perform in the presence of food processing interventions and byproducts of those interventions used in the processing of FSIS regulated products.
Specific Requirements
The test system shall be a commercially available system that has approval by a scientifically recognized entity (e.g. AOAC, AFNOR) or been approved by an equivalent organization as determined by FSIS following guidelines similar to those at the following address:
https://www.fsis.usda.gov/wps/wcm/connect/966638c7-1931-471f-a79e-4155ce461d65/Validation_Studies_Pathogen_Detection_Methods.pdf?MOD=AJPERES
The validation of the test system leading to approval must have included matrices used in FSIS regulatory testing. The test system validation results must be provided to FSIS in response to the RFI. The test system shall be semi-automated or fully automated. The test system shall be able to directly interface with the FSIS Laboratory Information Management System. The system shall be rugged enough to process hundreds of samples a day requiring little maintenance or repair over the course of a year. The system may be either semi-quantitative or quantitative for bacterial pathogens regulated by FSIS in addition to detection of those bacterial pathogens. The technology may be capable of subtyping pathogens in addition to identification of pathogens. The system may detect all, some or only one of the bacterial pathogens regulated by FSIS. The technology should be capable of inclusion as a screening tool in current methodologies where cultural confirmation is performed as per the MLG. Additionally, the technology should meet any stated regulatory definitions of pathogens as described in the MLG. Information about FSIS Regulatory testing for bacterial pathogens can be located in the MLG and is posted at the following website:
Microbiology Laboratory Guidebook
http://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/microbiology-laboratory-guidebook/microbiology-laboratory-guidebook
Information Sought/Capability Statement
Interested respondents having the specialized capabilities to meet the above requirement should submit a capability statement indicating the ability to perform aspects of the effort described herein. Respondents shall discuss the proposed testing equipment, procedures, methods, options or technologies it believes would benefit FSIS.
The potential suppliers will need to determine the limits of detection and describe the method used to determine the limits of detection for each pathogen tested. The respondent should submit a description of the protocol used to determine the limits of detection that should reflect tests runs in the appropriate matrices (not water or buffer). A complete description of the procedure, along with estimated times required from sample preparation to screen result, should be submitted.
Validation data must be included. The validation data must include sensitivity, selectivity, and specificity; limits of detection, relative sensitivity, or other appropriate measure; limit of quantitation (if applicable), ruggedness and method uncertainty. The test system should be designed for high volume, high throughput sample screening/analysis. The test system must be such that one person can analyze one or more batches of samples within a standard work day or automated for overnight analysis.
The respondent shall generate or submit data on a range of bacterial pathogens and in what matrices they were detected. If data needs to be generated, the respondent should plan on completing the data package prior to submitting a response to this RFI, so it may be included. Data packages will not be returned.
After a review of the submitted data, parties may be invited to submit more detailed information to discuss their information further.
HOW TO RESPOND TO THE REQUEST FOR INFORMATION
1) The capability statement should include references, key personnel, and any teaming arrangements needed to fulfill the requirements. It must identify the responder's name and address of firm; contact and phone number, number of employees; size of business (large or small), small disadvantaged business, 8(a) firm, HUBZone small business, woman-owned small business, Historically Black College or University, and/or service-disabled veteran-owned small business; DUNS number; NAICS code; and technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
2) Respondent's capability statement should include a list of customers (Government/non-Government) over the past three (3) years highlighting relevant work performed in nature, scope, complexity, and difficulty and a brief description of the scope of work. A description of this experience should include the following:
• Contract name
• Contracting Agency or Department
• Point of contact
• Yearly contract dollar value
• Period of performance
• Description of work and how it relates to the above requirement
3) All vendors interested in responding to the RFI must provide a response to the questions in Attachment A.
FORMAT, DELIVERY DATE, AND POINT OF CONTACT
All RFI/capability statements must be submitted electronically no later than 3:00 PM EST on Wednesday, March 1, 2017 to Sheila Edmonds, Contracting Officer at sheila.edmonds@fsis.usda.gov. Questions concerning this RFI may be submitted via email only to sheila.edmonds@fsis.usda.gov no later than 2:00 PM EST on Tuesday, February 14, 2017. No telephone inquiries will be honored. Faxed responses are not permitted.
The capability statement should contain enough sufficient detail for the Government to make an informed decision regarding an entity's capacity and potential. The capability statement should not exceed ten (10) 8 ½ x 11 pages not including the test data.
DISCLAIMER AND IMPORTANT NOTES: This RFI 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. Information provided will be used by FSIS to assess capable sources, tradeoff, and alternatives available for the potential requirement which may lead to the development of a solicitation. 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 (FBO). However, responses to this notice will not be considered adequate responses to a solicitation.
PROPRIETARY INFORMATION: Responses containing confidential, proprietary, or privileged information must be conspicuously marked as described below. Failure to comply with these marking requirements may result in the disclosure of the unmarked information under the Freedom of Information Act or otherwise. The Government is not liable for the disclosure or use of unmarked information, and may use or disclose such information for any purpose.
If your response contains confidential, proprietary, or privileged information, you must include a cover sheet marked as follows, identifying the specific pages containing confidential, proprietary, or privileged information:
Notice of Restriction on Disclosure and Use of Data:
Pages [list applicable pages] of this response may contain confidential, proprietary, or privileged information that is exempt from public disclosure. Such information shall be used or disclosed only for the purposes described in this RFI AG-3A94-S-17-0017. The Government may use or disclose any information that is not appropriately marked or otherwise restricted, regardless of source.
In addition, (1) the header and footer of every page that contains confidential, proprietary, or privileged information must be marked as follows: "Contains Confidential, Proprietary, or Privileged Information Exempt from Public Disclosure" and (2) every line and paragraph containing proprietary, privileged, or trade secret information must be clearly marked with double brackets or highlighting.
Sheila R. Edmonds, Contracting Officer, Phone 3013444752, Email sheila.edmonds@fsis.usda.gov
