ATTACHMENT A Performance Work Statement.pdf

RFP 123A9422R0003

ATTACHMENT A

Performance Work Statement

Food Safety and Inspection Service for

Salmonella Enumeration Instruments, Reagents, and Kits

A. 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, and egg products are safe, wholesome, and accurately labeled. The FSIS Western, FSIS Midwestern, and FSIS Eastern Laboratories are regulatory laboratories that test meat, poultry, Siluriformes, egg products, and environmental samples to ensure that they are free of contamination or adulteration.

The current protocols for analytical tests are required by FSIS to perform regulatory activities on meat, poultry, Siluriformes, egg products and environmental samples. Specifically, microbiological methods are presented for sample preparation, enrichment, isolation and identification of the major foodborne pathogenic microorganisms and their toxins, meat tissue species identification, and the detection of antimicrobial resistance.

B. Objective/Scope The objective of the requirement is to adequately equip all three FSIS Laboratories with Salmonella Enumeration Detection Instruments, kits and reagents. Through the selection of a single analytical platform, the laboratories shall have the capability to enumerate screen positive samples for:

a. Salmonella species

The laboratories require a commercially available off-the-shelf (COTS) product including but not limited to, instrumentation, software and reagents, available for laboratory testing. This requirement shall include a service agreement and replacement of equipment, if leased, assets as required for the duration of the resultant contract.

The FSIS Laboratories perform regulatory testing of more than 86,000 samples per calendar year of meat, poultry, egg products, Siluriformes and environmental samples for the presence of Salmonella spp. The Agency desires to enumerate Salmonella spp. in screen positive poultry samples.

Due to the large number of samples analyzed daily, and new sampling programs being implemented, FSIS desires to update its current instrument inventory and associated expendable supplies (kits and reagents).

C. Contractor Requirements The contractor’s equipment, test kits and reagents shall meet the following performance specifications:

a) Provide enumeration for Salmonella spp. in poultry rinsates, with expansion to enumerate other pathogens and in other product types preferred

b) Hold a third-party validation prior to this evaluation

c) Limit of detection of at least 10 colony-forming units.

d) Analytical run time cannot exceed two hours; preference given to technologies that do not require dilution steps.

e) Single analytical batch should approximate 90 samples

f) Current laboratory footprint shall be less than 2 square feet per instrument (due to limited space of FSIS laboratories).

g) Windows 10 Operating System or higher

h) Vendor shall submit power, infrastructure, environmental, etc. requirements for proposed equipment to be evaluated against the physical capacities at each laboratory location.

i) Compatible media and sample preparation with existing FSIS Salmonella enrichment procedures (FSIS MLG 4.11), preference given to methods that require no additional enrichment and still achieve the desired capability to enumerate Salmonella spp.

D. Contractor Tasks/ Deliverables:

1. The contractor (s) shall provide documentation to the COR that all parts and materials used for repairs/maintenance shall meet specific analytical platform requirements. The contractor shall maintain an adequate inventory of spare parts to accommodate the repair of equipment or instrument replacement within 48 hours.

2. The contractor(s) shall pay charges to ship replacement or repaired equipment to the customer and pay shipping charges for the return of equipment to the contractor.

3. The contractor(s) shall include all charges for shipping and handling for all kits and reagents to the purchase price of the kits and reagents.

4. The equipment shall be fully operational according to laboratory methodology and serviceable after installation and completion of maintenance and repairs. The COR or designated representative shall certify the equipment is performing satisfactorily.

5. Help desk support shall be required during normal local business hours for equipment service support. If issues are not fixed within that day of normal business hours, a technician must be dispatched to the lab for servicing.

6. The contractor(s) shall provide the COR with information on the names of all employees who shall require access to the facility, in order to perform work on equipment, including approximate date and time of arrival. All employees provided by contractor shall have valid picture identification and must comply with federal and local facility CoVID-19 measures before being allowed onto the premises.

7. Maintenance/repair services hours shall be provided during normal working hours, 7:30AM to 5:00PM (local time), Monday through Friday, excluding Federal Holidays (see https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=Overview for a listing of the Federal Holidays). If work is required outside of this timeframe, then the Contractor and Government shall work out agreeable terms for these instances. Response time should not exceed 24 hours and return to functionality not to exceed 48 hours unless alternative arrangement with the particular lab is agreed upon.

8. The contractor(s) shall provide training: Lab set-up, equipment validation, and operational training.

https://www.fsis.usda.gov/sites/default/files/media_file/2021-08/MLG-4.11.pdf https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=Overview

9. Shipping: The Contractor shall deliver the equipment within 30 to 45 calendar days after receipt of order.

10. The price for the kits and reagents shall be determined based on a minimum number of kits and/or reagents purchased with discounts for additional quantities in 1,000 test increments.

For example, Agency shall initially agree to procure a minimum of 10,000 tests in one calendar year (comprised of combination of Salmonella enumeration kits and reagents, etc.).

Depending on operational needs, the Agency shall then expect progressively reduced price per unit by increasing the requirement in 1,000 increments.

11. Equipment placed in each location for testing purposes shall remain at each site and for program implementation, upon successful evaluation and vendor award. Additionally, vendor will supply an additional instrument to each location within 30-45 days after successful award.

E. Evaluation The contractor shall furnish equipment, supplies, kits, media, and reagents needed, including any enrichment systems or media, to test each category of pathogens in paragraph B above to the USDA, FSIS, OPHS Laboratories listed at the locations below. The testing phase will last 3-6 weeks. Vendors and technologies will be compared to an aerobic plate count where the correlation should be greater than or equal to 0.75 (R2 ≥ 0.75) and evaluated on criteria in Appendix A and best cost to the government.

Eastern Laboratory: Frankie Beacorn, 950 College Station Rd, Athens, GA 30605 Midwestern Laboratory: Terry Dutko, 4300 Goodfellow Blvd. St. Louis, Missouri 63120 Western Laboratory: Curtis Wallis, 800 Buchanan Street, Albany, California 94710

F. Equipment Lease or Purchase The determination of purchase or lease shall depend on the price, terms and availability of funding. The instruments shall enable all USDA FSIS Food Safety Laboratories to use Salmonella enumeration detection instruments and kits over the course of five years in accordance with FAR 7.4, Equipment Lease or Purchase.

G. Period of Performance The period of performance shall be a Base Year plus four (4) Option Years from the date of award.

H. Commonly Accepted Security Configurations for Windows Operating Systems By delivering applications under this contract/order, the Contractor certifies that such applications are fully functional and operate as intended on systems using the Windows 10 Security TIG Version 2.

Additionally, they shall comply with eAuthentication and other Federal mandates such as Personal Identity Verification (PIV) card known as LincPass. This includes the latest approved versions of Microsoft supported web browsers, Operating System, RedHat Linux, and iOS for mobile device management.

The standard installation, operation maintenance, updates, and patching of all software shall not alter the configuration settings from the approved configuration. If a configuration change is necessary, the Contractor will supply the configuration change and the business reason for its deviation. The complete list of Windows 10 STIG settings can be provided by FSIS security upon request. Applications designed for normal end-users shall run in the standard user context without elevated system administration privileges.

I. 508 Compliance Accessibility of Electronic and Information Technology

(a) This SOW 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 shall 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 shall 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 shall 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.

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. https://www.access-board.gov/ict/

4. FAR 39.2 (Section 508)

5. USDA Standards, policies and procedures (Section 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 - shall 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 shall comply with https://www.access-board.gov/ict/ 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) https://www.access-board.gov/ict/ (508 Standards)

(4) FAR 39.2 (Section 508)

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

a. Information Technology – General Information https://www.ocio.usda.gov/sites/default/files/docs/2012/DR4030- 001_Section_508_Program.htm

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

36 CFR Part 1194.22 (a – p) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) https://www.access-board.gov/ict/ (508 Standards)

(4) FAR 39.2 (Section 508)

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

a. Information Technology – General Information https://www.ocio.usda.gov/sites/default/files/docs/2012/DR4030-https://www.access-board.gov/ict/ http://www.ocio.usda.gov/508/index.html#resources http://www.ocio.usda.gov/508/index.html#resources http://www.ocio.usda.gov/508/index.html#resources https://www.access-board.gov/ict/ http://www.ocio.usda.gov/508/index.html#resources http://www.ocio.usda.gov/508/index.html#resources

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

36 CFR Part 1194.23 (a – k) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) https://www.access-board.gov/ict/ (508 Standards)

(4) FAR 39.2 (Section 508)

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

a. Information Technology – General Information

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

36 CFR Part 1194.24 (a – e) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) https://www.access-board.gov/ict/ (508 Standards)

(4) FAR 39.2 (Section 508)

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

a. Information Technology – General Information

For self-contained, closed products, the Contractor shall comply with the standards, policies, and procedures below:

36 CFR Part 1194.25 (a – j) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) https://www.access-board.gov/ict/ (508 Standards)

(4) FAR 39.2 (Section 508)

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

a. Information Technology – General Information https://www.ocio.usda.gov/sites/default/files/docs/2012/DR4030- 001_Section_508_Program.htm For Desktop and portable computers, the Contractor 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.ocio.usda.gov/508/index.html#resources http://www.ocio.usda.gov/508/index.html#resources https://www.access-board.gov/ict/ http://www.ocio.usda.gov/508/index.html#resources http://www.ocio.usda.gov/508/index.html#resources http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm https://www.ocio.usda.gov/sites/default/files/docs/2012/DR4030-001_Section_508_Program.htm https://www.ocio.usda.gov/sites/default/files/docs/2012/DR4030-001_Section_508_Program.htm shall comply with the standards, policies, and procedures below:

36 CFR Part 1194.26(a – d) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) https://www.access-board.gov/ict/ (508 Standards)

(4) FAR 39.2 (Section 508)

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

a. Information Technology – General Information

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 shall have a Section 508 acceptance test and Section 508 shall be validated upon acceptance.

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

http://www.access-board.gov/sec508/508standards.htm https://www.ocio.usda.gov/sites/default/files/docs/2012/DR4030-001_Section_508_Program.htm https://www.ocio.usda.gov/sites/default/files/docs/2012/DR4030-001_Section_508_Program.htm