A02 - SOW- IPA_Analysis_Match_Explorer_software (1).docx

STATEMENT OF WORK

Contents:

STATEMENT OF WORK (SOW)

Title: IPA Analysis Match Explorer software

Requiring Activity Name: Medical Readiness Systems Biology Branch (MRSB), Walter Reed Army Institute of Research (WRAIR)

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. Established in 1893, our research and development now reach around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

The Medical Readiness Systems Biology (MRSB) branch aims to apply robust and precise molecular-based solutions for military-relevant health performance, resilience, and readiness. MRSB is a disease-agnostic program that utilizes high-throughput, multi-omics platforms supported by a suite of cutting edge, targeted assay tools and AI-driven analytical capabilities to identify diagnostic and prognostic biomarkers to generate a knowledge base about biological mechanisms and personalized care. MRSB is committed to developing a seamless, integrative module enabling to interrogate genome-to-phenome landscape to inform medical interventions and develop products to improve Warfighter health, performance, resilience, and readiness.

3. SCOPE

MRSB requires Ingenuity pathway analysis (IPA), which is a powerful analysis software suite for genomics, transcriptomics, epigenomics and metabolomics. This software is used to quickly visualize and understand complex ‘omics data and perform insightful data analysis and interpretation by placing your experimental results within the context of biological systems. IPA is being used extensively for several projects funded by MOMRP, CDMRP, DHA, CCCRP and all of which are mission critical for the identification of Biomarkers.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

5. WORK SCHEDULE AND LOCATION

5.1. The vendor shall provide support during the same hours as the supported Government organization.

5.1.1. Government Facility Office Hours: The Government facility office hours are 0800 to 1700, Monday through Friday except U.S. Holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

5.2. The products shall be provided for Medical Readiness Systems Biology (MRSB) branch, Walter Reed Army Institute of Research (WRAIR) located at 503 Robert Grant Ave, Silver Spring, MD 20910.

6. PERFORMANCE REQUIREMENTS

6.1. Tasks

6.1.1. The vendor shall provide software and support within five (5) days of award

6.1.2. The vendor shall provide live technical phone support at no additional cost, support availability must match Government facility office hours listed in 5.1.1.

6.1.3. The vendor must meet all required specifications listed in 6.2.

6.2 . Minimum Essential Characteristics

Required Specifications:

· Documentation: Comprehensive documentation should be provided, including user manuals, FAQs, and troubleshooting guides, to assist users of the software.

· Training and Support: Adequate training and support should be available to users, enabling them to make the most of the software and address any questions or difficulties they may encounter.

· Trusted Platform Module (TPM) 2.0

· Compatibility: Regular checks should be conducted to ensure compatibility with different operating systems, browsers, and hardware configurations, providing a seamless experience for users.

· Timely Response: Maintenance and support should provide prompt responses to user queries and issues, ensuring a quick turnaround time.

· Bug Fixing: Regular bug fixing is necessary to address any software glitches or technical problems that may arise.

· Security Updates: Regular security updates should be implemented to protect the system from vulnerabilities and ensure the safety of user data.

· Software Updates: Periodic software updates are essential to enhance the functionality, stability, and performance, incorporating new features and improvements.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

7.1. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsibilities is responsible for inspection and acceptance of study design, implementation, data evaluation, and modifications.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the terms and conditions of this order, including all modifications.

7.2. COR Information

TBD

8. COMPLIANCE DOCUMENTS

8.1. General Compliance

8.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Material Command (USAMRMC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

8.1.2. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program. http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-1, Information Technology. http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

c) Army Regulation 25-2, Information Assurance.

d) Department of Defense (DOD) Instruction 8500.01 Cybersecurity

e) Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program: http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

9. OTHER TERMS, CONDITIONS, AND PROVISIONS

9.1. Invoices

The contractor shall submit invoices monthly and/or annually to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. Invoices submitted for payment, which do not contain Contract Line-Item Number (CLIN) and the Accounting Classification Reference Number (ACRN) information, will be rejected. Equipment purchases and ODCs are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

9.2. Anti-Terrorism and Operational Security

All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable.

DFARS 204.7202 Contractor personnel who, as a condition of contract performance, require routine physical access to a Federally controlled facility or military installation are required to complete Level I antiterrorism awareness training within 30 days of access and annually thereafter.

Include the clause at DFARS 252.204-7004 DoD Antiterrorism Awareness Training for Contractors, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, when contractor personnel require routine physical access to a Federally controlled facility or military installation.

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

9.3. Compliance with Relevant DoD, Service, and Institutional Policy Regulations

The Contractor shall comply with HIPAA and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and PHI. In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g., Public Affairs clearance and Operational Security clearance for dissemination).

9.4. Personally Identifiable Information (PII) and Protected Health Information (PHI)

The contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 17 May 2015. The contractor may access PII during task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

IT services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C., DoD 5400.11 and DoD 5400.11-R. DoDI 5400.16 established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C.