Attachment 001 - PWS.pdf

US Department of Agriculture (USDA)

Performance Work Statement

Contents Project Title General Information

1.0 Background and Purpose

Contractor Requirements

2.0 Technical Requirements / Tasks

2.1 Technical Criteria

2.2 Operational Criteria

2.3 Repair and Maintenance Criteria

2.4 Information Technology Criteria

3.0 Performance Requirement Measures

4.0 Deliverable / Schedule

5.0 Government Furnished Property/Equipment/Information

6.0 Travel

7.0 Physical Security Requirements

8.0 Section 508 - Electronic and Information Technology Standards

Project Title Shiga Toxin-Producing Escherichia coli (STEC) Screening New Tech

General Information

1.0 Background and Purpose

The 3 (three) Field Service Labs (FSLs) at the Food Safety and Inspection Service (FSIS), a public health regulatory agency of the U.S. Department of Agriculture (USDA), require an updated contract for screening and confirmation of Shiga Toxin-producing Escherichia coli (STEC). Current methods can be found online in Microbiology Laboratory Guidebook (MLG) 5C.01.

The objective is to adequately equip all three FSIS Laboratories with the capability to test approximately 20,000 beef samples for STEC.

1.1 Type of Contract Contemplated

FSIS plans to issues a Firm Fixed-Price Indefinite Delivery Indefinite Quantity (IDIQ) contract.

1.6 Period of Performance

The period of performance for this contract consists of a base year and four option years, estimated to begin in January 2024.

Contractor Requirements

2.0 Technical Requirements / Tasks

Written proposals will be evaluated by subject matter expert(s). The Government will evaluate the Contractor’s-proposal in accordance with the Technical Evaluation Criteria identified in the Solicitation. Those contractors who “pass” are to provide to all three (3) FSIS Laboratories methods, associated instrumentation, kits, supplies, and technical support as outlined in the Section 4.0 Deliverable/Schedule “Testing Phase.” These proposals will be evaluated in the lab to determine best fit for purpose.

Minimum - $20,000 Maximum - $4,000,000

This procurement will include a service agreement and replacement of equipment, if leased, and assets as required for the duration of the resultant contract.

The FSIS Laboratories plans to screen approximately 20,000 regulatory samples for Shiga Toxin-Producing Escherichia coli (STEC) per fiscal year, with additional testing planned for potential, presumptive and confirmatory analyses.

2.1 Technical Criteria

The contractor’s equipment, test kits and reagents are to meet the following performance specifications. Proposals that do not meet the minimum requirements numbered 1-18 will not be eligible for acceptance into the testing phase or contract award.

1. Uses an enriched sample and isolated colony, as prescribed in MLG 5C – including all equipment/steps required from enriched sample to colony confirmation

2. Target pathogens will include Shiga Toxin-Producing Escherichia coli (STEC) O157, O26, O45, O103, O111, O121, and O145.

a. Preference given to genes/virulence that cause human illness

3. Target genes will include eae and stx 1/2

a. Results should be reported separately – one result for eae and separate result for stx 1/2

4. Achieve 90% accuracy of detection of target organisms

5. Achieve 90% accuracy of detection of non-target organisms

6. Accuracy, compared to cultural method, 90% or higher

7. Positive predictive value, 90% or higher

8. Negative predictive value, 90% or higher

9. Accurate results for complete panel of strains for inclusivity and exclusivity

10. Minimum limit of detection (LOD) of 104 colonies

11. Method will have a published validation by an internationally recognized, third-party standards organization

12. Capable of creating .csv or compatible files for importing and exporting data and templates https://www.fsis.usda.gov/sites/default/files/media_file/2021-04/MLG-5C.01.pdf https://www.fsis.usda.gov/sites/default/files/media_file/2021-04/MLG-5C.01.pdf

13. Provides a run report with positive and negative results

a. Preference given to .pdf versions of results from instrument without analyst manipulation

14. Analyze at least 96 tests on a single instrument (minimum)

15. Information Technology components will meet current Government requirement and be compatible with Windows

16. Require laboratory benchtop footprint of less than 10 linear square feet for instrument, hardware, PC and additional components

a. Instrumentation is to include all mandatory components from initial screen of enriched sample up to final confirmation on the MALDI.

b. Optional components should be identified and use will be at the discretion of the government.

17. Operate within manufacturer's operational specifications within the existing environments of the three FSIS laboratories, including maximum power requirements of 120 Volts, 10 Amps AC

Additionally, proposals will be evaluated on the following technical criteria. An award will be made to the offeror that performs best.

19. Expiration date of unopened materials/reagents must be at least 6 months or longer

20. Provide an expedited sample prep time, not to exceed a total of one hour

21. Provide an expedited analytical run time, not to exceed 2 hours

22. Lysate can be reanalyzed after initial run (at least 24 hours)

23. Kit controls are optional and not mandatory

2.2 Operational Criteria

24. The Contractor’s Help Desk support will be available during normal local laboratory business hours for equipment service and support

25. Ancillary consumables (tips, blocks, media, etc.) must have alternate supply chain avenues available when proprietary consumables are required

2.3 Repair and Maintenance Criteria

26. The Contractor(s) will provide documentation to the COR that all parts and materials used for repairs/maintenance of instrumentation meet manufacturer’s operational specifications

27. The Contractor will maintain an adequate inventory of spare parts to accommodate the repair of equipment within 48 hours of service requested by the Government

a) Conditional performance required during evaluation period. If a reported issue cannot be resolved during normal business hours (see Section 6) the same day the issue is reported, a technician must be dispatched to the lab within 24 hours of initial outage report.

28. The Contractor(s) will pay shipping charges for replacement or repaired equipment to the customer and pay shipping charges for the return of equipment to the Contractor

2.4 Information Technology Criteria

Contractors are encouraged to meet IT security compliance below and should indicate in the proposal if and how they can meet Agency OCIO IT security measures

29. 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)

30. Compliance with applicable Privacy Act Laws of 1974 regulation to safeguard all sensitive and confidential information, including personally identifiable information (PII).

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

32. 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.

33. Comply USDA policy for security awareness training for all employees and contractors who have access to sensitive data.

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

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

3.0 Performance Requirement Measures

The Government will evaluate vendor proposals and make a determination of technical acceptability based off written proposals. If selected for in-laboratory evaluation, the vendor-provided methods and associated instrumentation, kits, supplies, support, and associated performance work criteria will be evaluated based on requirements listed in the Section

2. If a procurement award is granted, equipment will be distributed to all three Field Service laboratories located in Athens, Ga, St. Louis MO, and Albany CA as outlined in the award deliverables section of this document. The government is under no obligation to grant an award to those considered.

The determination of purchase or lease will depend on the price, terms and availability of funding. The instruments are to enable all USDA FSIS Food Safety Laboratories to use Pathogen Identification Instruments and Kits over the course of five years in accordance with FAR 7.4, Equipment Lease or Purchase.

4.0 Deliverable / Schedule

The Contractor shall adhere to the following schedule and deliverable requirements for the “Testing Phase.”

Item Deliverable Name Due Date No. of Copies

Format Addressee

1 The contractor is to deliver equipment, software, essential documents, and licenses required to permit the Government laboratory to perform the proposed method according to manufacturer specifications. If electrical power equipment (e.g., uninterrupted power supplies, line conditioners, etc.) or other environmental control items are needed for proper operation of the equipment, the contractor is to provide those items as well.

Receipt at the three Field Service laboratories no earlier than 30 days following the acceptance into the testing phase and no later than 60 days after the acceptance date.

1 at each lab

NA 3 Field Service Laboratories:

USDA FSIS OPHS Midwestern Laboratory Attn: Brittny Gaines 4300 Goodfellow Road St. Louis, MO 63120

USDA FSIS OPHS Eastern Laboratory Attn: Cesar Morales 950 College Station Road Athens, GA 30605

USDA FSIS OPHS Western Laboratory Attn: William J. Zaragoza 800 Buchanan Street Albany, CA 94710

2 Installation performed by a factory trained field service engineer.

Within two weeks of delivery of the instrument.

1 at each lab

NA NA

3 Initial configuration of the system.

At time of installation.

1 at each lab

NA NA

4 Demonstration of system specifications upon installation.

At time of installation.

1 at each lab

NA

5 Physical copies of (1) software installation media and (2) the qualified system controller image.

At time of installation.

1 of each per lab

DVD or Solid-state USB drive

6 Copies of system management and user manual(s).

At time of installation.

2 at each lab

Electronic PDF file and paper formats

7 User Training At time of installation.

1 at each lab

Demonstration

8 Supplies to test samples will need to be provided for the testing phase*.

*Actual quantity of supplies will be determined with evaluation team at the start of the testing phase. Supplies to be split between the 3 laboratories.

Receipt at the three Field Service laboratories no earlier than 30 days following the acceptance into the testing phase and no later than 60 days after the acceptance date.

NA NA 3 Field Service Laboratories:

USDA FSIS OPHS Midwestern Laboratory Attn: Brittny Gaines 4300 Goodfellow Road St. Louis, MO 63120

USDA FSIS OPHS Eastern Laboratory Attn: Cesar Morales 950 College Station Road Athens, GA 30605

USDA FSIS OPHS Western Laboratory Attn: William J. Zaragoza 800 Buchanan Street Albany, CA 94710

The Contractor is to adhere to the following schedule and deliverable requirements for the “Award Phase."

Item Deliverable Name Due Date No. of Copies

Format Addressee

1 The contractor is to deliver equipment, software, essential documents, and licenses required to permit the Government laboratory to perform the proposed method according to manufacturer specifications. If electrical power equipment (e.g., uninterrupted power supplies, line conditioners, etc.) or other environmental control items are needed for proper operation of the equipment, the contractor is to provide those items as well.

Receipt at the 3 Field Service Laboratories no earlier than 30 days following the contract award date and no later than 60 days after the contract award date.

Negotiated during award based on current inventory

NA 3 Field Service Laboratories:

USDA FSIS OPHS Midwestern Laboratory Attn: Brittny Gaines 4300 Goodfellow Road St. Louis, MO 63120

USDA FSIS OPHS Eastern Laboratory Attn: Cesar Morales 950 College Station Road Athens, GA 30605

USDA FSIS OPHS Western Laboratory Attn: William J. Zaragoza 800 Buchanan Street Albany, CA 94710

2 Installation performed by a factory trained field service engineer.

Within two weeks of delivery of the instrument.

Negotiated during award based on current inventory

NA NA

3 Initial configuration of the system.

At time of installation.

Negotiated during award based on current inventory

NA NA

4 Demonstration of system specifications upon installation.

At time of installation.

Negotiated during award based on current inventory

NA 3 Field Service Laboratories

5 Physical copies of (1) software installation media and (2) the qualified system controller image.

At time of installation.

1 of each per lab

DVD or Solid-state USB drive

3 Field Service Laboratories

6 Copies of system management and user manual(s).

At time of installation.

2 at each lab

Electronic PDF file and paper formats

3 Field Service Laboratories

7 User Training At time of installation.

Negotiated during award based on current training

Demonstration 3 Field Service Laboratories

8 Software Line Item Pricing (if applicable) (see Software License Line Item Data (May 2018) clause

Within 10 days of Award, or Within 10 Days of Software Activation for Licenses provided after award date

1 Electronic PDF file

Contracting Officer’s Representative for forwarding to the Evaluation Team

9 Certificates of Analysis At time of installation.

1 of each per lab

Electronic PDF file

Contracting Officer’s Representative for forwarding to the Evaluation Team

5.0 Government Furnished Property/Equipment/Information

• No Government Furnished Property (GFP) or Government Furnished Equipment (GFE) will be provided in support of this contract. In accordance with FAR 45.102, contractors are ordinarily required to furnish all property necessary to perform contracts, and government property is provided only under limited circumstances.

• Access to Government Facility: Preventative maintenance visits shall be provided during normal business hours, 8:00am to 4:00pm (local time), Monday through Friday, excluding Federal Holidays (see https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/ for a listing of the Federal Holidays). If work is required outside of this timeframe, then the Contractor and Government will work out agreeable terms for these instances.

• Inspection and Acceptance: The COR will act, on-site, as the technical point of contact for the Government, initiate service calls, and perform acceptance of equipment after maintenance and repairs. The COR’s authority is limited to technical issues, and he/she is not authorized to make contractual decisions. The authority to resolve monetary issues and contractual interpretation is the sole responsibility of the Contracting Officer.

6.0 Travel

Annual preventive maintenance service visits shall not incur additional charges for travel. This is a firm fixed-price contract and travel reimbursement is not be authorized On-site visits to USDA, FSIS, OPHS, Eastern Laboratory, Midwestern Laboratory, and Western Laboratory (locations below) are required annually to perform maintenance on the instruments.

• Eastern Laboratory – 950 College Station Rd, Athens, GA 30605, US

• Midwestern Laboratory – 4300 Goodfellow Blvd, Bldg 105-D, St. Louis, MO 63120-0005, US

• Western Laboratory – 800 Buchanan St, Albany, CA 94710, US https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

7.0 Physical Security Requirements

The contractor shall provide the COR with information on the names of all employees who will require access to the facility to perform work on equipment, including approximate date and time of arrival. This should be provided at least 24 hours in advance of work being performed. All employees provided by contractor must have valid picture identification before being allowed onto the premises. If the supported item meets the criteria that establish it as an information system, the item must provide for completion of the Assessment and Accreditation (A&A) process in accordance with the USDA Risk Management Framework Process Guide to ensure the appropriate security controls and configuration baselines are implemented. If the supported item meets the criteria that establish it as an information system, the item shall include documentation with information describing the functional properties of the security controls to be employed within the information system, information system components, or information system services in sufficient detail to permit analysis and testing of the controls.

8.0 Section 508 - Electronic and Information Technology Standards E201.1 Scope ICT that is procured, developed, maintained, or used by agencies shall conform to the Revised 508 Standards.

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".

E206.1 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.

E207.1 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.

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

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.