A04_SOW.pdf

STATEMENT OF WORK FOR

ANIMAL PLANT HEALTH AND INSPECTION SERVICE (APHIS)

Marketing & Regulatory Programs Business Services (MRPBS)

Information Technology Division

Laboratory & Scientific Information Technology

A-Tune Animal Management System Implementation

March 12, 2026

Project A-Tune System Procurement and Implementation

General Information

1.0 Scope of Work

This is a brand name requirement for procurement of the a-tune Animal Management System (AMS). This system is required to be used by our Animal Resources Unit in the management of animals being utilized at NBAF. This will be a Base+4 Firm Fixed Price contract to be bid on for implementation and current/future system licensing.

2.0 Background

The Integrated Research Animal Management System is an electronic information management system which will manage research animals used at the USDA. Additionally, this management system will aid the Institutional Biosafety Committee (IBC) in oversight of recombinant DNA research for research using animals or plants, and the Institutional Biosafety Subcommittee in oversight of infectious and hazardous agents. The Animal Care Compliance Office, IBC must be able to track and manage the use of rDNA, hazardous and biological toxins using plants and research animals, their use of history, meeting agendas and minutes, and veterinary care records of each animal as required by law.

One specific goal of this Statement of Work is to maintain an efficient and secure electronic solution that meets the current needs of USDA, their customers/stakeholders and comply with security and confidentiality regulations and requirements.

USDA maintains a need for a comprehensive and integrated Animal Management System Commercial-Off-The- Shelf (COTS) software product. After thorough market research and testing, the a-tune AMS was the only system capable of providing the necessary technical capability to meet both regulatory and NBAF animal management requirements.

3.0 Period of Performance

The period of performance includes a base period of 12 months for initial licensing and system implementation (timeline of implementation to be determined within the base period), and two 12‐month option periods for system license/support renewal. The Contractor shall perform the effort required by this Performance Work Statement (PWS) on a Firm Fixed Price basis. Work shall be performed in accordance with all sections of this PWS.

4.0 Technical Requirements

• This system meets the following capability requirements:

o Data Management

• Ability to create and pull reports of data entered from IBC and IACUC submissions (e.g., agents, room numbers, PIs, form status, etc.) Any custom reports that A-tune is requested to build will be billed at our current Professional Services hourly rate card.

• Maintain a non-editable audit trail history of user interactions and activity.

• Based on User Role Permissions, the ability to easily view protocol statuses, history, and approvals.

• Front end user analytic capability to build and export data needed for compliance and audit reporting.

• Ability for manager and investigator role to view IBC protocols and statuses.

• Allows configuration of site, facility, building, floor, and room data for facility management. Must allow for 60+ locations to be defined.

• Define master data, such as facility, animal vendors, cages, and treatments.

• Maintain animal census information with RFID or BARCODE CAGE CARD tracking, breeding, husbandry data, animal utilization and protocol transfers.

• Search all animal studies and their associated protocols and protocol schedules, events, and activities

• Report upon intended DURC research, hazard and risk evaluations, IBC review, and DURC registration status.

• All personnel listed on protocol need to be able to view protocol on dashboard.

• Ability to interface import lab results from hematology/chem machines/ultrasound/radiology exams

• Ability to pull data for from IBC submissions to assist with generating IBC agendas, minutes, approval letters, etc.

• Ability to import/associate inspection data with rooms

• Ability to pull data for from IBC submissions to assist with generating IBC agendas, minutes, approval letters, etc.

• Import and support telemetry sensor data to capture and monitor animal health statistics and behavior

• Track and report DEA controlled substance inventory. Ideally will Interface with Omnicell for DEA inventory. This is not currently in tick@lab but we are in the process of building a pharmacy module.

• Searchable for diagnosis or clinical signs to study trends over time o Process Management

• Application comes OTB with a baseline set of IBC and IACUC workflows that are up-to-date with current standards

• Application comes OTB with a baseline set of IBC and IACUC Protocol Templates that are up-to-date with current standards

• Baseline IBC and IACUC workflows can be configured to meet business needs with minimal intervention from the vendor. This does not require any code changes or customization to the application.

• Ability for an admin to configure review cycles. Such as how long between reviews, who they go to, and notifications

• Easy to use protocol creation, reviews, and submission in accordance with IACUC and IBC workflows.

• Ability to perform and document internal and external IACUC and IBC compliance audits.

• Allow researchers, and veterinary resources to attach files at various workflow stages. Example formats include.pdf, .tiff, .jpg, Word, Excel, PP, .MP3 and .MP4, and other instrument file outputs.

• Allow manager to add or remove selections from any drop downs in protocol.

• Allow manager to collect reviewer comments and submit to investigator

• Ability to create, manage, and update DURC research, hazard and risk evaluations, IBC review, and DURC registration status. Setting this up is considered extended configuration and will be billed at the current Professional Services rate card.

• Support IBC and/or IACUC committee meeting management to create agendas, record minutes, and outcomes.

• Support animal and cage tracking with the use of barcode technology.

• Support veterinary care, health record creation, and animal treatments.

• Manage, track, and maintain all animal studies and attached protocols and protocol schedules events and activities.

• Provide animal incident reporting and tracking.

• Support IBC compliance with form creation, reviews, and submission.

• Ability to configure clinical medical records to meet business needs. i.e. to include SOAP, Anesthesia, treatment plans, research procedures, necropsy or path reports

• Animal ID tracking with easy-to-follow history and notes from arrival to euthanasia.

• Herd Health Record Capability. Example: apply the same procedure to 200 cattle without having to enter the data 200 times.

• Animal study creation and animal study management

• Ability to configure or trigger automated reminder notifications via email for IBC/IACUC renewals

• Highlighted track changes for edits made to protocols after submission

• Ability to generate PDFs of protocols

• Ability to track reviewer appointment dates and send reminder to manager of appointment expiration

• Allow manager to make modifications directly to protocol forms

• Allow manager to create review panels and assign protocols to different panels

• Allow investigator to clone protocols

• Able to have multiple protocol forms to accommodate different submission types o User Management

• Unique user identification, electronic signatures, and passwords.

• User account creation and setup through front end UI or integration from HRMS.

• Manage resource training and competency records through integration.

o Technical System Requirements

• Support integration through application programming interface (API) access to external systems, if desired.

• Meet the requirements of the Code of Federal Regulations (CFR), specifically, 21 CFR part 11 except for electronic signatures.

• Authenticate users via Active Directory or Lightweight Directory Access Protocol.

• Provide users with the ability to query and report upon historical data.

• The application is supported for use on mobile or tablet devices.

• The system shall support industry-standard SSO protocols (e.g., SAML 2.0, OAuth 2.0, OpenID Connect) for secure user authentication.

• Demonstrate enterprise capability through the software and vendor to support scalable deployment.

• Support web-based deployment.

• Support enhancements / configurations / extensions /customizations using standard technology as opposed to using proprietary language.

• Deployable within the Azure Gov cloud environment.

• Flexibility of the licensing model to include concurrent and named users.

• Provide users ability to submit data via electronic forms Link to data natively, or selectively extract data to support a data aggregation layer Configure and make available for data export information in common formats (e.g. Excel, PDF).

• All third-party software, libraries, frameworks, and components upon which the system depends shall be kept up to date with the latest stable, patched, and officially supported versions.

5.0 Place of Performance

Implementation will occur remotely via collaboration between the vendor’s team and the NBAF IT Team.

6.0 Contractor Personnel

QUALIFIED PERSONNEL

The Contractor shall furnish all personnel necessary to accomplish work required by this contract and shall ensure personnel meet training and experience requirements of this PWS. Contractor staff must be able to interpret and comply with safety and regulatory guidelines.

The Contractor and all contractor personnel shall possess all licenses, permits, training and certifications required to perform the contract requirements. Contractor personnel shall work in a professional and courteous manner, present a neat appearance, and abide by applicable USDA/NBAF rules, regulations, and procedures while working at NBAF facilities. The Contractor shall provide curriculum vitae of all key personnel listed under clause entitled “Key Personnel” proposed under this contract. The individuals’ training and qualifications shall meet all contract requirements for the position in which they are working.

KEY PERSONNEL

The contractor shall provide Key Personnel in accordance with the minimum requirements listed.

Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance. Substitution or replacement personnel shall be replaced with 30 days.

Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract are listed as Key Personnel in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the people that are listed in the proposal.

The following shall be considered Key Personnel roles:

• Senior Project Manager

• Senior System (A-Tune) Consultant

7.0 Deliverables/Schedule

Key Deliverables

Deliverable Objective Period of

Performance

Project Schedule

Overall plan to provide necessary configuration as described in this SOW

Two weeks from award

A-Tune Implementation, Configurations, and User

Acceptance Testing (UAT)

Management

Deliver continued implementation as outlined in this SOW

Throughout PoP

A-Tune Implementation, Configurations, and User

Acceptance Testing (UAT)

Execution

Deliver continued implementation as outlined in this SOW

Throughout PoP

A-Tune Training and creation of training materials for all NBAF personnel utilizing the system

Deliver adequate training and training materials

(documents and video) that can be leveraged as post-training reference

Throughout PoP

Prepare and deliver software documentation requested to support NBAF’s compliance with ISO17025 validation requirements. This may include, but is not limited to, Installation Qualification, Design and testing documentation, and Release

Notes

Provide documentation to ensure federal regulatory guidance

Throughout PoP

Go-Live Production Support

Deliver adequate technical and functionality support for four weeks after the Go-

Live date

Upon completion of all other

Deliverables

8.0 Government Furnished Equipment

The government will provide a GFE laptop to each individual sponsored by USDA that are required to obtain a LincPass PIV card and USDA access accounts for work performed under this contract, that requires secure access to the NBAF instance of the software. Sponsorship for a LincPass will require the individuals to undergo an appropriate background investigation.

9.0 Security Requirements

a. Background Investigations/Suitability Requirements

The Contractor shall provide only fully qualified personnel for the work performed under this contract.

Contractor personnel shall have the appropriate background investigation known as a National Agency Check with written Inquiry and Credit (NACIC). U.S. citizenship is required for all contractor personnel working on this order that require access to USDA systems. Contractor personnel shall be able to obtain and maintain a favorable adjudication of a background investigation as required to obtain a government Personal Identity Verification (PIV) card.

b. Protection of Information

The component parts of this effort and reports are expected to contain highly sensitive information that could act as a guide for hostile entities to cause harm to the Federal Government’s critical infrastructure. Any information made available to the Contractor in any format shall be used only for the purpose of carrying out the provisions of this contract. Such information shall not be divulged or made known in any manner to any person. The Contractor shall immediately notify the COR, CO, and PM upon discovery of any inadvertent disclosures of information. The Contractor shall not retain any information regarding vulnerabilities, to include summaries, actual vulnerability reports, etc., at the end of the contract or performance period. All information arising from this agreement, both hard copy and electronic, shall be returned to the U.S. Government at the end of the contract.

10.0 Section 508 – Electronic and Information Technology Standards

On August 7, 1998, President Clinton signed into law the Rehabilitation Act Amendments of 1998, which covers access to federally funded programs and services. The law strengthens section 508 of the Rehabilitation Act and requires access to electronic and information technology provided by the Federal government. The law applies to all Federal agencies when they develop, procure, maintain, or use electronic and information technology. Federal agencies must ensure that this technology is accessible to employees and members of the public with disabilities to the extent it does not pose an “undue burden.” Section 508 speaks to various means for disseminating information, including computers, software, and electronic office equipment. It applies to, but is not solely focused on, Federal pages on the Internet or the World Wide Web. It does not apply to web pages of private industry.

The Board is responsible for developing accessibility standards for such technology for incorporation into regulations that govern Federal procurement practices. The net result will be that Federal agencies will have to purchase electronic and information technology that is accessible except where it would cause an “undue burden.” The law also provides a complaint process under which complaints concerning access to technology will be investigated by the responsible Federal agency.

Text of Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C. §794d)

§794d. Electronic and information technology

(a) Requirements for Federal departments and agencies

(1) Accessibility

(A) Development, procurement, maintenance, or use of electronic and information technology

When developing, procuring, maintaining, or using electronic and information technology, each Federal department or agency, including the United States Postal Service, shall ensure, unless an undue burden would be imposed on the department or agency, that the electronic and information technology allows, regardless of the type of medium of the technology –

(i) individuals with disabilities who are Federal employees to have access to and use of information and data that is comparable to the access to and use of the information and data by Federal employees who are not individuals with disabilities; and

(ii) individuals with disabilities who are members of the public seeking information or services from a federal department or agency to have access to and use of information and data that is comparable to the access to and use of the information and data by such members of the public who are not individuals with disabilities.

(B) Alternative means efforts

When development, procurement, maintenance, or use of electronic and information technology that meets the standards published by the Access Board under paragraph (2) would impose an undue burden, the Federal department or agency shall provide individuals with disabilities covered by paragraph (1) with the information and data involved by an alternative means of access that allows the individual to use the information and data.

(2) Electronic and information technology standards

(A) In general

Not later than 18 months after August 7, 1998, the Architectural and Transportation Barriers Compliance Board (referred to in this section as the ‘Access Board’), after consultation with the Secretary of Education, the Administrator of General Services, the Secretary of Commerce, the Chairman of the Federal Communications Commission, the Secretary of Defense, and the head of any other Federal department or agency that the Access Board determines to be appropriate, including consultation on relevant research findings, and after consultation with the electronic and information technology industry and appropriate public or nonprofit agencies or organizations, including organizations representing individuals with disabilities, shall issue and publish standards setting forth–

(i) for purposes of this section, a definition of electronic and information technology that is consistent with the definition of information technology specified in section 5002(3) of the Clinger‐Cohen Act of 1996 (40 U.S.C.

1401(3)); and

(ii) the technical and functional performance criteria necessary to implement the requirements set forth in paragraph (1).

(B) Review and amendment

The Access Board shall periodically review and, as appropriate, amend the standards required under subparagraph (A) to reflect technological advances or changes in electronic and information technology.

(3) Incorporation of standards

Not later than 6 months after the Access Board publishes the standards required under paragraph (2), the Federal Acquisition Regulatory Council shall revise the Federal Acquisition Regulation, and each Federal department or agency shall revise the Federal procurement policies and directives under the control of the department or agency to incorporate those standards. Not later than 6 months after the Access Board revises any standards required under paragraph (2), the Council shall revise the Federal Acquisition Regulation and each appropriate Federal department or agency shall revise the procurement policies and directives, as necessary, to incorporate the revisions.

(4) Acquisition planning

If a Federal department or agency determines that compliance with the standards issued by the Access Board under paragraph (2) relating to procurement imposes an undue burden, the documentation by the department or agency supporting the procurement shall explain why compliance creates an undue burden.

(5) Exemption for national security systems

This section shall not apply to national security systems, as that term is defined in section 5142 of the Clinger‐ Cohen Act of 1996 (40 U.S.C. 1452).

(6) Construction

(A) Equipment

In a case in which the Federal Government provides access to the public to information or data through electronic and information technology, nothing in this section shall be construed to require a Federal department or agency –

(i) to make equipment owned by the Federal Government available for access and use by individuals with disabilities covered by paragraph (1) at a location other than that where the electronic and information technology is provided to the public; or

(ii) to purchase equipment for access and use by individuals with disabilities covered by paragraph (1) at a location other than that where the electronic and information technology is provided to the public.

(B) Software and peripheral devices

Except as required to comply with standards issued by the Access Board under paragraph (2), nothing in paragraph (1) requires the installation of specific accessibility-related software or the attachment of a specific accessibility related peripheral device at a workstation of a Federal employee who is not an individual with a disability.

(b) Technical assistance

The Administrator of General Services and the Access Board shall provide technical assistance to individuals and Federal departments and agencies concerning the requirements of this section.

(c) Agency evaluations

Not later than 6 months after August 7, 1998, the head of each Federal department or agency shall evaluate the extent to which the electronic and information technology of the department or agency is accessible to and usable by individuals with disabilities described in subsection (a)(1), compared to the access to and use of the technology by individuals described in such subsection who are not individuals with disabilities, and submit a report containing the evaluation to the Attorney General.

(d) Reports

(1) Interim report

Not later than 18 months after August 7, 1998, the Attorney General shall prepare and submit to the President a report containing information on and recommendations regarding the extent to which the electronic and information technology of the Federal Government is accessible to and usable by individuals with disabilities described in subsection (a)(1).

(2) Biennial reports

Not later than 3 years after August 7, 1998, and every 2 years thereafter, the Attorney General shall prepare and submit to the President and Congress a report containing information on and recommendations regarding the state of Federal department and agency compliance with the requirements of this section, including actions regarding individual complaints under subsection (f).

(e) Cooperation

Each head of a Federal department or agency (including the Access Board, the Equal Employment Opportunity Commission, and the General Services Administration) shall provide to the Attorney General such information as the Attorney General determines is necessary to conduct the evaluations under subsection (c) and prepare the reports under subsection (d).

(f) Enforcement

(1) General

(A) Complaints

Effective 6 months after the date of publication by the Access Board of final standards described in subsection (a) (2), any individual with a disability may file a complaint alleging that a Federal department or agency fails to comply with subsection (a)(1) of this section in providing electronic and information technology.

(B) Application

This subsection shall apply only to electronic and information technology that is procured by a Federal department or agency not less than 6 months after the date of publication by the Access Board of final standards described in subsection (a) (2).

(2) Administrative complaints

Complaints filed under paragraph (1) shall be filed with the Federal department or agency alleged to be in noncompliance. The Federal department or agency receiving the complaint shall apply the complaint procedures established to implement section 794 of this title to resolve allegations of discrimination in a federally conducted program or activity.

(3) Civil actions

The remedies, procedures, and rights set forth in sections 794a(a)(2) and 794a(b) of this title shall be the remedies, procedures, and rights available to any individual with a disability filing a complaint under paragraph (1).

(g) Application to other Federal laws

This section shall not be construed to limit any right, remedy, or procedure otherwise available under any provision of Federal law (including sections 791 through 794(a) of this title) that provides greater or equal protection for the rights of individuals with disabilities than this section.