Draft_SOW_New_Detection_Technologies.pdf

Statement of Work Dated August 15, 2017

Project Title:

New Detection Technologies

BACKGROUND

The Food Safety and Inspection Service (FSIS), a public health regulatory agency of the U.S.

Department of Agricultural (USDA), protects consumers by ensuring that meat, poultry, Siluriformes (catfish), and processed egg products are safe, wholesome, and accurately labeled. The FSIS Field Service Laboratories (FSL), located in Saint Louis, MO, Athens, GA, and Albany, CA, are regulatory laboratories that analyze meat, poultry, Siluriformes, and pasteurized egg products to ensure they are free from adulteration, both chemical and microbiological.

OBJECTIVE AND SCOPE

USDA/FSIS plans to acquire a rapid, high throughput, multi-analyte test system to detect and identify bacterial pathogens to include, but not be limited to, Salmonella, Shiga toxin-producing Escherichia coli (STEC) serotype O157:H7, non-O157 STEC, Listeria monocytogenes, and Campylobacter. The system will be used to detect bacterial pathogens in food products and food producing environments regulated under the Poultry Inspection Act (PIA), Egg Products Inspection Act (EPIA), and the Federal Meat Inspection Act (FMIA), including Siluriformes, which was added under the 2008 and 2014 Farm Bills. The system must demonstrate the capacity to perform as requested above using sample matrices encompassed under these Acts.

In fiscal year 2016, FSIS analyzed approximately 120,000 samples for pathogenic bacteria.

Although FSIS cannot precisely determine how many tests will be needed in the future, this figure should be used as a guide to determine price estimates.

SPECIFIC REQUIREMENTS

The test system must be a commercially available system that has been approved and validated by a scientifically recognized entity such as the Association of Analytical Communities (AOAC) and/or the Association Francaise Normalisation (AFNOR) or other equivalent and approved organization(s) using procedures and guidelines comparable to those as described by FSIS found 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 must include matrices used in FSIS regulatory testing. The test system validation results must be provided in the Contractor’s proposal. The test system should be semi-automated or fully automated. The results derived using the test system must be able to interface with the FSIS Laboratory Information Management System. The detection system must be rugged enough to process hundreds of samples a day requiring little maintenance or repair over the course of a year. In addition to detection of bacterial pathogens of importance found in food commodities regulated by FSIS, a system that is quantitative or semi-quantitative is preferred. Another desired feature of the technology -- would be the ability -to subtype pathogens (e.g. Discriminate Salmonella spp. subtypes such as distinguishing Salmonella Typhimurium and Salmonella Enteritidis). The technology must be capable of https://www.fsis.usda.gov/wps/wcm/connect/966638c7-1931-471f-a79e-4155ce461d65/Validation_Studies_Pathogen_Detection_Methods.pdf?MOD=AJPERES https://www.fsis.usda.gov/wps/wcm/connect/966638c7-1931-471f-a79e-4155ce461d65/Validation_Studies_Pathogen_Detection_Methods.pdf?MOD=AJPERES inclusion as a screening tool in current methodologies where cultural confirmation is performed as per the Microbiology Laboratory Guidebook (MLG) used by FSIS. Additionally, the technology must 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

SPECIFIC TECHNICAL REQUIREMENTS

The Contractor shall submit a description of the proposed testing equipment, procedures, methods, options, or technologies it believes would benefit FSIS.

The Contractor must describe the limits of detection and the method(s) used to determine the limits of detection for each pathogen tested. The Contractor must submit a description of the protocol(s) used to determine the limits of detection; this should include tests run in the appropriate matrices (not water or buffer). The Contractor must submit a complete description of the procedure which includes the estimated time required from sample preparation to screen result.

The Contractor must provide validation data. The validation data must include sensitivity, selectivity, and specificity including the limits of detection. The Contractor must also provide a description of the relative sensitivity or other appropriate measure. Where applicable, the Contractor must provide the limit and method of quantitation as well as ruggedness and method uncertainty. The test system must be designed for high throughput sample screening/analysis.

The test system must be such that an individual worker can analyze ideally more than one batch of samples within a standard work day or the system should be capable of automation for overnight analysis.

The Contractor shall provide validation data when available on the bacterial pathogens of FSIS interest and include matrices in which they were validated. USDA/FSIS will not return data packages.

SPECIAL IT REQUIREMENTS

The Successful Offeror must provide a Voluntary Product Assessment Template (VPAT) prior to the government’s adoption of the technology. Information on this requirement can be found at https://www.section508.gov/content/sell/vpat.

PERIOD OF PERFORMANCE

The period of performance shall be a Base Year with four (4) Option Years.

http://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/microbiology-laboratory-guidebook/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 https://www.section508.gov/content/sell/vpat

SECTION 508 COMPLIANCE ACCESSIBILITY OF ELECTRONIC AND INFORMATION

TECHNOLOGY (MAR 2015)

(a) This SOW/PWS or TO is subject to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C.

794d) as amended by the workforce Investment Act of 1998 (P.L. 105-220). Specifically, subsection 508(a)(1) requires that when the Federal Government procures Electronic and Information Technology (EIT), the EIT must allow Federal employees and individuals of the public with disabilities comparable access to and use of information and data that is provided to Federal employees and individuals of the public without disabilities.

(b) The EIT accessibility standards at 36 CFR Part 1194 were developed by the Architectural and Transportation Barriers Compliance Board ("Access Board") and apply to contracts and task/delivery orders, awarded under indefinite quantity contracts on or after June 25, 2001.

(c) Each Electronic and Information Technology (EIT) product or service furnished under this contract shall comply with the Electronic and Information Technology Accessibility Standards (36 CFR 1194), as specified in the contract, as a minimum. If the Contracting Officer determines any furnished product or service is not in compliance with the contract, the Contracting Officer will promptly inform the Contractor in writing. The Contractor shall, without charge to the Government, repair or replace the non-compliant products or services within the period of time to be specified by the Government in writing. If such repair or replacement is not completed within the time specified, the Government shall have the following recourses:

1. Cancellation of the contract, delivery or task order, purchase or line item without termination liabilities; or

2. In the case of custom Electronic and Information Technology (EIT) being developed by a contractor for the Government, the Government shall have the right to have any necessary changes made or repairs performed by itself or by another firm for the noncompliant EIT, with the contractor liable for reimbursement to the Government for any expenses incurred thereby.

(d) The contractor must ensure that all EIT products that are less than fully compliant with the accessibility standards are provided pursuant to extensive market research and are the most current compliant products or services available to satisfy the contract requirements.

(e) For every EIT product or service accepted under this contact by the Government that does not comply with 36 CFR 1194, the contractor shall, at the discretion of the Government, make every effort to replace or upgrade it with a compliant equivalent product or service, if commercially available and cost neutral, on either a contract specified refresh cycle for the product or service, or on a contract effective option/renewal date; whichever shall occur first.

Section 508 Compliance for Communications

The vendor shall comply with the standards, policies, and procedures below. In the event of conflicts between the referenced documents, the SOW shall take precedence.

Rehabilitation Act, Section 508 Accessibility Standards

1. 29 U.S.C. 794d (Rehabilitation Act as amended)

2. 36 CFR 1194 (508 Standards)

3. www.access-board.gov/sec508/508standards.htm (508 standards)

4. FAR 39.2 (Section 508)

5. USDA Standards, policies and procedures (Section 508) http://www.access-board.gov/sec508/508standards.htm%20(508

In addition, all contract deliverables are subject to these 508 standards as applicable.

Regardless of format, all Web content or communications materials produced, including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents above. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW shall be the responsibility of the contractor or consultant.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

36 CFR Part 1194.21 a - l 36 CFR Part 1194.22 a - p 36 CFR Part 1194.31 a - f 36 CFR Part 1194.41 a – c

The contractor shall provide a completed Section 508 Product Assessment Template and the contractor shall state exactly how proposed EIT deliverable(s) meet or does not meet the applicable standards.

The following Section 508 provisions apply for software development material identified in this SOW, PWS, or TO:

For software development, software applications, and operating systems the Contractor/Developer/Vendor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.21 (a – l) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources

For web-based applications (intranet, internet information and applications, 16 rules), the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.22 (a – p) 36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508) http://www.access-board.gov/sec508/508standards.htm http://www.access-board.gov/sec508/508standards.htm

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources

For Telecommunication products the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.23 (a – k) 36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

For video and multimedia applications (including training), the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.24 (a – e) 36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources For self-contained, closed products, the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.25 (a – j) 36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

For Desktop and portable computers, the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.26(a – d) 36 CFR Part 1194.31 (a – f) http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm http://www.ocio.usda.gov/508/index.html#resources

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources

For the purposes of this SOW, the Contractor shall review the complete system for 508 compliance and correct all deficiencies or document exceptions as required by departmental and federal requirements.

All Electronic Information Technology that is subject to the 36 CFR 1194 standards will have a Section 508 acceptance test and Section 508 will be validated upon acceptance.

All maintenance for Electronic Information Technology that requires upgrades, modifications, installations and purchases will adhere to the Section 508 Standards and 36 CFR 1194.