Statement of Objectives - Request for Information STEC tests kits.pdf

US Department of Agriculture (USDA)

Statement of Objectives

Contents Project Title

1.0 Purpose

2.0 Scope

3.0 Background

4.0 Performance Objectives

4.1 Company Overview and Capability Summary

4.2 Technical Capabilities

4.3 Validation, Data, & Supporting Evidence

4.4 Information Technology (IT) Capabilities

5. Deliverables

6.0 Section 508

Project Title Commercial Products used to Detect and Identify Shiga toxin-producing Escherichia coli (STEC) in Food

1.0 Purpose

The purpose of the Statement of Objectives (SOO) is to gather information on the commercial availability of kits for STEC detection and identification in raw beef or other food products. FSIS seeks to understand the level of granularity in STEC tests, specifically if the test provides stx subtype information.

2.0 Scope

The USDA Food Safety and Inspection Service (FSIS) Laboratory System continually incorporates new approaches to our laboratory testing and data analytics workflows to increase efficiencies in our food safety system. For example, FSIS laboratories incorporated an additional screening test into the STEC laboratory method to provide high confidence that the stx and eae genes are in the same cell, thereby increasing the likelihood that a screen positive result leads to a confirmed positive. The Agency is data driven and is considering best approaches to optimize risk-based regulatory controls for STEC.

3.0 Background

FSIS is the public health regulatory agency within the USDA responsible for inspecting establishments producing meat, poultry, and egg products and verifying that these products are safe, wholesome, and properly labeled. FSIS employs approximately 7,500 people, including inspection personnel working in 7,100 federally inspected establishments, scientists and staff in three FSIS laboratories, and investigators nationwide. The high throughput FSIS laboratories operate 365 days a year, analyzing hundreds of product samples each day to identify potential hazards and threats to the food supply. During Fiscal Year 2025, FSIS analyzed more than 109,000 meat, poultry and pasteurized eggs samples submitted by inspectors, which produced more than12,900 bacterial isolates and generated more than 2.2 million individual test results. FSIS annually tests more than 20,000 raw beef samples, including domestic and imported raw ground beef, ground beef components, bench trim, and beef manufacturing trim for the presence of the “top seven” STEC serogroups (O26, O45, O103, O111, O121, O145, O157). The current methodology can be found online in Microbiology Laboratory Guidebook (MLG) 5C.

4.0 Performance Objectives

4.1 Company Overview and Capability Summary

• Provide a brief overview of the vendor's portfolio of testing kits and or technologies that can be used to support STEC testing that detects and identifies stx/eae carrying strains regardless of serogroup (even those outside of the U.S. top seven STEC).

4.2 Technical Capabilities

• Describe relevant methods, kits, workflows, media and/or technology platforms.

• Is the product compatible with meat-based microbiology testing methods and samples?

https://www.fsis.usda.gov/sites/default/files/media_file/documents/MLG-5C.04.pdf o If yes, list compatible matrices and sample types.

• Does the technology, if applicable, provide the specific subtype of stx genes in STEC?

o If yes, list subtype(s) of stx genes the technology can detect and identify.

• Describe performance characteristics (e.g., sensitivity, specificity, accuracy, positive predictive value, negative predictive value, limit of detection, inclusivity, exclusivity, robustness).

• Describe operational requirements (equipment, training, sample prep time, analytical run time, run capacity, throughput, environmental needs, power requirements – voltage and amperage, temperature and humidity requirements, laboratory footprint).

• Provide technology costs on a per kit basis. List and identify any ancillary and proprietary supplies or reagents. Include anticipated shipping surcharges as a separate line item.

o Include options for purchase (provide line items for maintenance agreement plans), lease and placement if available.

4.3 Validation, Data, & Supporting Evidence

• Does your company have third-party validation by recognized independent organizations (i.e., AOAC, AFNOR, MicroVal, NordVal) for the test kit?

o If yes, provide supporting documentation.

• Is there available validation data, internal/external studies, regulatory certifications?

o If yes, provide supporting documentation.

• List data formats, reporting structures, and result output for the test.

4.4 Information Technology (IT) Capabilities

• Indicate (yes/no) if you can meet the USDA Office of the Chief Information Officer IT security measures below o Compliance with standards and guidelines from the Federal Information Security Modernization Act (FISMA) of 2014, and adherence to National Institute of Standards and Technology (NIST) Special Publication 800-53 Revision 5 standards and guidelines (ex., scanning of laboratory equipment every 72 hours for security vulnerabilities, mitigation of identified critical security risks in 14 days, and 30 days for non-critical vulnerabilities) o Compliance with applicable Privacy Act Laws of 1974 regulation to safeguard all sensitive and confidential information, including personally identifiable information

(PII).

o Implementation of access controls to safeguard confidentiality of sensitive data and systems to ensure only authorized individuals have access.

o Adherence to NIST 800-53 Rev 5 security and HSPD-12 standards to ensure adequate security measures are enforced for remote access, including multifactor authentication and encryption.

o Compliance with USDA policy for security awareness training for all employees and contractors who have access to sensitive data.

o Compliance with organization policy regarding the implementation of incident response procedures to address security incidents, including breach notification requirements.

o Regular security audits and assessments to ensure ongoing compliance with security control requirements.

5. Deliverables Please respond to each item concisely and in plain language. You may also include links to online materials or interactive presentations. Submissions should include the following:

• The name of the individual(s) and/or organization responding.

• A brief description of the responding individual(s) or organization's mission and/or areas of expertise.

• A point of contact for questions or other follow-up on your response.

By responding to the SOO, each participant (individual, team, or legal entity) warrants that they are the sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original (or is an improved version of an existing work that the participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which participant is aware.

By responding to the SOO, each participant (individual, team, or legal entity) consents to the contents of their submission being made available to all Federal agencies and their employees on an internal-to-government website accessible only to agency staff persons.

Participants will not be required to transfer their intellectual property rights to the USDA, but participants must grant to the Federal Government a nonexclusive license to apply, share, and use the materials that are included in the submission. To participate in the SOO, each participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of participant rights to the Federal Government. Interested parties who respond to this SOO may be contacted for follow-on questions or discussion.

6.0 Section 508

E201 Application

E201.1 Scope. ICT that is procured, developed, maintained, or used by agencies shall conform to the Revised 508 Standards.

E205 Electronic Content

E205.1 General. Electronic content shall comply with E205.

E205.2 Public Facing. Electronic content that is public facing shall conform to the accessibility requirements specified in E205.4.

E205.3 Agency Official Communication. Electronic content that is not public facing shall conform to the accessibility requirements specified in E205.4 when such content constitutes official business and is communicated by an agency through one or more of the following:

• A. An emergency notification;

• B. An initial or final decision adjudicating an administrative claim or proceeding;

• C. An internal or external program or policy announcement;

• D. A notice of benefits, program eligibility, employment opportunity, or personnel action;

• E. A formal acknowledgement of receipt;

• F. A survey questionnaire;

• G. A template or form;

• H. Educational or training materials; or

• I. Intranet content designed as a Web page.

E205.4 Accessibility Standard (WCAG 2.0). Electronic content shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (Incorporated by reference, see 702.10.1).

E205.4.1 Word Substitution when Applying WCAG to Non-Web Documents. For non-Web documents, wherever the term "Web page" or "page" appears in WCAG 2.0 Level A and AA Success Criteria and Conformance Requirements, the term "document" shall be substituted for the terms "Web page" and "page". In addition, in Success Criterion in 1.4.2, the phrase "in a document" shall be substituted for the phrase "on a Web page".

E206 Hardware

E206.1 General. Where components of ICT are hardware and transmit information or have a user interface, such components shall conform to the requirements in Chapter 4.

E207 Software

E207.1 General. Where components of ICT are software and transmit information or have a user interface, such components shall conform to E207 and the requirements in Chapter 5

Exception from E207.1 General: Software that is assistive technology and that supports the accessibility services of the platform shall not be required to conform to the requirements in Chapter 5.

E207.2 WCAG Conformance. User interface components, as well as the content of platforms and applications, shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

Exceptions from E207.2 WCAG Conformance:

• Software that is assistive technology and that supports the accessibility services of the platform shall not be required to conform to E207.2.

• Non-web software shall not be required to conform to the following four Success Criteria in WCAG 2.0: 2.4.1 Bypass Blocks; 2.4.5 Multiple Ways; 3.2.3 Consistent Navigation; and 3.2.4 Consistent Identification.

• Non-Web software shall not be required to conform to Conformance Requirement 3 Complete Processes in WCAG 2.0.

E207.3 Complete Process for Non-Web Software Where non-Web software requires multiple steps to accomplish an activity, all software related to the activity to be accomplished shall conform to WCAG 2.0 as specified in E207.2.

E208 Support Documentation and Services

E208.1 General. Where an agency provides support documentation or services for ICT, such documentation and services shall conform to the requirements in Chapter 6.

E301 General

E301.1 Scope. The requirements of Chapter 3 shall apply to ICT where required by 508 Chapter 2 (Scoping Requirements), 255 Chapter 2 (Scoping Requirements), and where otherwise referenced in any other chapter of the Revised 508 Standards or Revised 255 Guidelines.

E302 Functional Performance Criteria

302.1 Without Vision. Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that does not require user vision.

302.2 With Limited Vision. Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited vision.

302.3 Without Perception of Color. Where a visual mode of operation is provided, ICT shall provide at least one visual mode of operation that does not require user perception of color.

302.4 Without Hearing. Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that does not require user hearing.

302.5 With Limited Hearing. Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited hearing.

302.6 Without Speech. Where speech is used for input, control, or operation, ICT shall provide at least one mode of operation that does not require user speech.

302.7 With Limited Manipulation. Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that does not require fine motor control or simultaneous manual operations.

302.8 With Limited Reach and Strength. Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that is operable with limited reach and limited strength.

302.9 With Limited Language, Cognitive, and Learning Abilities. ICT shall provide features making its use by individuals with limited cognitive, language, and learning abilities simpler and easier.

502 Interoperability with Assistive Technology

502.4 Platform Accessibility Features. Platforms and platform software shall conform to the requirements in ANSI/HFES 200.2, Human Factors Engineering of Software User Interfaces — Part 2: Accessibility (2008) (incorporated by reference, see 702.4.1) listed below:

• A. Section 9.3.3 Enable sequential entry of multiple (chorded) keystrokes;

• B. Section 9.3.4 Provide adjustment of delay before key acceptance;

• C. Section 9.3.5 Provide adjustment of same-key double-strike acceptance;

• D. Section 10.6.7 Allow users to choose visual alternative for audio output;

• E. Section 10.6.8 Synchronize audio equivalents for visual events;

• F. Section 10.6.9 Provide speech output services; and

• G. Section 10.7.1 Display any captions provided.

503 Applications

503.1 General. Applications shall conform to 503.

503.2 User Preferences. Applications shall permit user preferences from platform settings for color, contrast, font type, font size, and focus cursor.

Exception from E503.2 User Preferences: Applications that are designed to be isolated from their underlying platform software, including Web applications, shall not be required to conform to 503.2.

503.3 Alternative User Interfaces. Where an application provides an alternative user interface that functions as assistive technology, the application shall use platform and other industry standard accessibility services.

503.4 User Controls for Captions and Audio Description Where ICT displays video with synchronized audio, ICT shall provide user controls for closed captions and audio descriptions conforming to 503.4.

503.4.1 Caption Controls Where user controls are provided for volume adjustment, ICT shall provide user controls for the selection of captions at the same menu level as the user controls for volume or program selection.

503.4.2 Audio Description Controls. Where user controls are provided for program selection, ICT shall provide user controls for the selection of audio descriptions at the same menu level as the user controls for volume or program selection.

504 Authoring Tools

504.1 General. Where an application is an authoring tool, the application shall conform to 504 to the extent that information required for accessibility is supported by the destination format.

504.2 Content Creation or Editing Authoring tools shall provide a mode of operation to create or edit content that conforms to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1) for all supported features and, as applicable, to file formats supported by the authoring tool. Authoring tools shall permit authors the option of overriding information required for accessibility.

504.2.1 Preservation of Information Provided for Accessibility in Format Conversion. Authoring tools shall, when converting content from one format to another or saving content in multiple formats, preserve the information required for accessibility to the extent that the information is supported by the destination format.

504.2.2 PDF Export. Authoring tools capable of exporting PDF files that conform to ISO 32000- 1:2008 (PDF 1.7) shall also be capable of exporting PDF files that conform to ANSI/AIIM/ISO 14289- 1:2016 (PDF/UA-1) (incorporated by reference, see 702.3.1).

504.3 Prompts. Authoring tools shall provide a mode of operation that prompts authors to create content that conforms to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1) for supported features and, as applicable, to file formats supported by the authoring tool.

504.4 Templates. Where templates are provided, templates allowing content creation that conforms to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1) shall be provided for a range of template uses for supported features and, as applicable, to file formats supported by the authoring tool.

602 Support Documentation

602.1 General. Documentation that supports the use of ICT shall conform to 602.

602.2 Accessibility and Compatibility Features. Documentation shall list and explain how to use the accessibility and compatibility features required by Chapters 4 and 5. Documentation shall include accessibility features that are built-in and accessibility features that provide compatibility with assistive technology.

602.3 Electronic Support Documentation. Documentation in electronic format, including Web-based self-service support, shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

602.4 Alternate Formats for Non-Electronic Support Documentation. Where support documentation is only provided in non-electronic formats, alternate formats usable by individuals with disabilities shall be provided upon request.

603 Support Services

603.1 General. ICT support services including, but not limited to, help desks, call centers, training services, and automated self-service technical support, shall conform to 603.

603.2 Information on Accessibility and Compatibility Features. ICT support services shall include information on the accessibility and compatibility features required by 602.2.

603.3 Accommodation of Communication Needs. Support services shall be provided directly to the user or through a referral to a point of contact. Such ICT support services shall accommodate the communication needs of individuals with disabilities.