DRAFT Product Description_Redivus Health Code Blue Software.pdf

PRODUCT DESCRIPTION

DEPARTMENT OF VETERANS AFFAIRS

Veterans’ Health Administration (VHA) Quality Management

Redivus Health Code Blue Software

Date: August 28th, 2025

VA-26-00009822

PD Version Number: 1.0

Contents

1.0 PRODUCT REQUIREMENTS

1.1 SALIENT CHARACTERISTICS

1.1.1 PROTOCOL GUIDANCE

1.1.2 COUNTDOWN TIMERS

1.1.3 ASSIST THE CLINICIAN IN DOSE AND OTHER CALCULATIONS

1.1.4 ENABLE THE CLINICIAN TO DOCUMENT ACTIVITIES REAL-TIME

DURING THE EVENT

1.1.5 ENABLE THE CLINICIAN TO DOCUMENT ASSESSMENTS AND

INTERVENTIONS

1.1.6 METRONOME AND AUDIO-OUT FEATURES

1.1.7 TEAM MEMBER MANAGEMENT

1.1.8 TIMELY, ACCURATE, AND EVIDENCE-BASED TREATMENT

1.1.9 ASSESSMENT, AUTHORIZATION, AND CONTINUOUS MONITORING 5

2.0 OPTIONAL TASK - ELECTRONIC HEALTH RECORD (EHR) INTEGRATION ... 8

3.0 NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL

INFORMATION AND COMMUNICATION TECHNOLOGY (ICT)

PROCUREMENTS (SECTION 508)

3.1 SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY

(ICT) STANDARDS

3.2 COMPATABILITY WITH ASSISTIVE TECHNOLOGY

3.3 ACCEPTANCE AND ACCEPTANCE TESTING

4.0 INFORMATION TECHNOLOGY USING SUSTAINABLE PRODUCTS AND

SERVICES

5.0 SHIPMENT OF HARDWARE OR EQUIPMENT

6.0 GENERAL REQUIREMENTS

6.1 VA TECHNICAL REFERENCE MODEL

6.2 ZERO TRUST – VA CRITICAL SECURITY CONTROLS

6.3 SOCIAL SECURITY NUMBER (SSN) REDUCTION

6.4 INTERNET PROTOCOL VERSION 6 (IPV6)

6.5 SOFTWARE AND LICENSING REQUIREMENTS

6.6 TRUSTED INTERNET CONNECTION (TIC)

6.7 POSITION/TASK RISK DESIGNATION LEVEL(S)

7.0 POINTS OF CONTACT

ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM SECURITY/

PRIVACY LANGUAGE

1.0 PRODUCT REQUIREMENTS

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Quality Management has a requirement to procure brand name Redivus Health Code Blue Software for a 12 month base and four (4) 12 month option periods. Contractor must provide device-independent solutions for the management of cardiac arrest, respiratory arrest, and deteriorating patients that incorporates many capabilities which no other supplier provides.

Capturing critical information during code blue events is arduous at best and can many times cause delays or confusion and provide incomplete data for post-incident assessment and process improvement. A "clinical GPS" of sorts is needed to able to provide step-by-step guidance that provides hospital clinical and code blue teams with manage events like cardiac arrest (aka code blue), sepsis, and stroke. A real-time augmented intelligence for nurses, doctors, and first responders is needed to ensure correct, complete data is captured and usable in post-code review.

This requirement is for Veterans Integrated Service Network (VISN) 21 to include the following facilities:

PLACE OF PERFORMANCE:

VA Pacific Islands Health Care System VA Sierra Nevada Health Care System 459 Patterson Road 975 Kirman Avenue Honolulu, HI 96819 Reno, NV 89502

VA Palo Alto Health Care System VA San Francisco Health Care System 3801 Miranda Avenue 4150 Clement Street Palo Alto, CA 94304 San Francisco, CA 94121

The following table contains the Code Blue Software product that the VA knows would meet the below salient characteristics (see Section 1.1), for the base period and the four

(4) option periods, if exercised.

Description Quantity Resuscitation (VA-Resus: 1001) 1182

1.1 SALIENT CHARACTERISTICS

The following are the salient characteristics required to meet the VA’s requirement:

1.1.1 PROTOCOL GUIDANCE

Protocol guidance through standard practice guidelines including chest compressions, defibrillator shocks, medication administration, and assessment of patient heart rhythms and vital signs

1.1.2 COUNTDOWN TIMERS

Countdown timers to inform and help guide clinicians in adherence of protocol defined time-based activities, including:

Total elapsed time of the event Elapsed time of the current compression cycle Elapsed time since the last administration of epinephrine Elapsed time since the last administration of amiodarone

1.1.3 ASSIST THE CLINICIAN IN DOSE AND OTHER CALCULATIONS

Assist the clinician in dose and other calculations including:

Joules dosing based on pediatric patient weight Medication dosing based on pediatric patient weight Airway sizes for cuffed/uncuffed Endotracheal tubes (ETT), Laryngeal

Mask Airway or i-gel based on pediatric patient weight

1.1.4 ENABLE THE CLINICIAN TO DOCUMENT ACTIVITIES REAL-TIME DURING

THE EVENT

Enable the clinician to document activities real-time during the event, including:

Medication administration including epinephrine dose and administration type, amiodarone dose, and other resuscitation medications Presence and administration of IV/IO central lines Airway presence, type, size, depth, placement Defibrillator shock activities Patient vital signs captured during the event IV fluids and blood products H’s and T’s of Advanced Cardiovascular Life Support (ACLS)/Pediatric

Advanced Life Support (PALS) checklist Free text and quick-comment auto-text to capture non-codified activities

Team members involved the event

1.1.5 ENABLE THE CLINICIAN TO DOCUMENT ASSESSMENTS AND

INTERVENTIONS

Enable the clinician to document assessments and interventions completed prior to the documentation initiation with editable timestamps

1.1.6 METRONOME AND AUDIO-OUT FEATURES

1.1.7 TEAM MEMBER MANAGEMENT

Team member management including:

Single user ownership of documentation activities Ability for multiple team members to view the documentation and event activities in a read only mode Ability to transition ownership of intervention timing and documentation responsibility from one team member to another during the code Print the final documentation after completion of the event Data analytics dashboard with ability to review a single event of compare multiple events

1.1.8 TIMELY, ACCURATE, AND EVIDENCE-BASED TREATMENT

The Redivus Code Blue application equips health systems to provide timely, accurate, and evidence-based treatment of cardiac arrests and respiratory arrests in alignment with the American Heart Association ACLS and PALS guidelines, acting as:

a digital version of a standardized checklist that is based on nationally-recognized practice guidelines or standard treatment protocols for either diagnosis or treatment of Adult and Pediatric cardiac arrests;

a countdown timer, with time intervals preset;

a record keeper for actions taken during an event; and an analytics dashboard that surfaces details about a specific event or group of events

1.1.9 ASSESSMENT, AUTHORIZATION, AND CONTINUOUS MONITORING

The Contractor’s solution will need to become Federal Risk and Authorization Management Program (FedRAMP) certified at the HIGH Data Security Categorization (FIPS 199) impact level.

(a) The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA).

(b) The Contractor shall comply with FedRAMP requirements - Data Security Categorization (FIPS 199) impact level is HIGH as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

(c) The Contractor shall provide a Software as a Service (SaaS) product as defined by the following criteria:

SaaS is an application delivery model in which the application is hosted on a cloud infrastructure outside the security boundary of VA and is provided to the Cloud Service Customer (CSC) over the internet. The CSC uses the SaaS offering via a thin-client interface, such as a web-browser or a program interface. The CSC subscribes to the SaaS offering and is only responsible for minor in-app customizations. The Cloud Service Provider (CSP) offering the application is responsible for management of the application, safeguarding of data stored or processed by the application, and all elements of the underlying infrastructure. Additionally, the CSP is responsible for all on-going compliance. In order to qualify as SaaS for use at VA, and to align with FedRAMP requirements, the hosting for the offering must conform to the NIST 800-145 definition of Cloud Computing and thus contain following key characteristics:

• On-Demand Self-Service: The CSP fully automates the provisioning of both the customer interface and the underlying cloud components of the SaaS offering. In some cases, to the CSP may provision internal resources manually, while providing the CSC an automated interface to request and track the service.

• Broad Network Access: The SaaS capabilities are available over the internet or over a network that is available from all access points the CSC requires. The SaaS offering is accessible through common platforms (e.g., mobile phones, tablets, laptops, and workstations).

• Resource Pooling: The computing infrastructure supporting the SaaS offering is shared among more than one CSC using a multi-tenant model, and resources are dynamically assigned depending on customer demand.

• Rapid Elasticity: Computing capabilities are automatically provisioned and released in a manner that scales with customer demand. In some cases, the scaling of resources may not be fully automated, but it should be fast enough to support the needs of the CSC, which the CSC would have to define.

Measured Service: Resource usage, such as storage, processing, bandwidth, and user activity are measured and reported on in a manner that is relevant to the SaaS offering.

The SaaS offering must be hosted within the United States and data stored/processed/transmitted within the offering must remain within the United States. CSPs should be aware of FedRAMP and ready to partner with VA through the SaaS FedRAMP Authorization process.

(d) Following guidance from the Federal CIO, VA will utilize existing Joint Authorization Board Authority to Operate (ATO) or agency ATO issued by another agency as a starting point for FedRAMP requirements. If neither of those exist, VA will sponsor The Cloud Service Provider for a FedRAMP Authorization. VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services.

(e) The Contractor shall, where applicable, assist with the VA ATO Process to help achieve agency authorization of the cloud service or migrated application at the impact level required by VA to utilize the product. For this solution the required impact level is: <<Insert Impact Level from the Data Security Categorization. This should be done by DTC.>>

(f) The Contractor shall complete a FedRAMP System Security Plan (SSP) and supporting documentation including required attachments within 75 calendar days after contract award. (If Data Security Categorization is High Impact, this will be due 94 calendar days after contract award.)

(g) The Contractor shall develop a VA specific system boundary diagram including any integration and connectivity components that will be known as a VA Implementation Diagram (VAID) demonstrating the proposed implementation of this system at VA. The Contractor shall provide the VAID within 10 calendar days of contract award.

(h) The Contractor shall complete a Third-Party Assessment Organization (3PAO) Security Assessment Plan (SAP) within 90 calendar days after contract award. (If Data Security Categorization is High Impact, this will be due after 113 calendar days after contract award.)

(i) The Contractor shall complete a 3PAO Security Assessment Report (SAR) within 90 calendar days after the SSP is accepted by VA. (If Data Security Categorization is High Impact, this will be due 113 calendar days after the SSP is accepted by VA.)

(j) Contractor shall work with assigned VA SME to develop a VA specific Incident Response Plan (IRP) and perform an IRP Table Top Exercise with VA Stakeholders. This should be completed within 30 calendar days of the SSP being delivered.

(k) The Contractor shall afford VA access to the Contractor’s and Cloud Service Provider’s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases.

(l) If new or unanticipated vulnerabilities are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with (IAW) Addendum B, VA Information and Information System Security/Privacy Language.

(m) The Contractor shall comply with data management requirements.

Successful issuance of a VA ATO will be required before live VA data can be used in the system.

Deliverables:

A. FedRAMP System Security Plan (SSP) and supporting documentation B. VA Implementation Diagram: This is a VA specific architecture diagram demonstrating the proposed implementation of this system at VA (VAID) C. 3PAO Security Assessment Plan (SAP) D. 3PAO Security Assessment Report (SAR) E. Incident Response Plan (IRP) Scenario

All deliverables will be Inspection and Acceptance: DESTINATION.

Days used within the Product Description refer to calendar days unless otherwise stated.

Deliverables with due dates falling on a weekend or holiday shall be submitted the following Government workday after the weekend or holiday.

Electronic submission to: VA Project Manager, Contracting Officer, and Contracting Officer’s Representative

2.0 OPTIONAL TASK - ELECTRONIC HEALTH RECORD (EHR) INTEGRATION

An optional service to support Electronic Health Record (EHR) integration to be available at additional charge to support the exchange of patient information from the EHR to simplify patient identification within the Code Blue application and to send a completed care document to the EHR. This service would include:

Admission, Discharge, and Transfer (ADT) Health Level Seven (HL7) interface outbound from EHR to Redivus, Medical Document Management (MDM) HL7 interface inbound to EHR from Redivus, and

The Redox integration platform using Virtual Private Network (VPN) access to the EHR is implemented to support this functionality

3.0 NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL

INFORMATION AND COMMUNICATION TECHNOLOGY (ICT)

PROCUREMENTS (SECTION 508)

On January 18, 2017, the Access Board issued a final rule that updated accessibility requirements covered by Section 508 and refreshed guidelines for telecommunications equipment subject to Section 255 of the Communications Act. The final rule went into effect on January 18, 2018. The revisions and updates to the Section 508-based standards and Section 255-based guidelines are intended to ensure that information and communication technology (ICT) covered by the respective statutes is accessible to and usable by individuals with disabilities.

3.1 SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY

(ICT) STANDARDS

The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT.

These standards are found in their entirety at: Revised 508 Standards and 255 Guidelines (access-board.gov). A single PDF file version of the Revised Section 508 Standards and 255 Guidelines will be supplied upon request, or can be obtained from the Access Board website. Federal agencies must comply with the Rehabilitation Act of 1973, as amended.

The Contractor shall comply with “508 Chapter 2: Scoping Requirements” for all electronic ICT and content delivered under this contract. Specifically, as appropriate for the technology and its functionality, the Contractor shall comply with the technical standards marked here:

☒ E205 Electronic Content – (Accessibility Standard -WCAG 2.0 Level A and AA Guidelines)

☒ E204 Functional Performance Criteria ☒ E206 Hardware Requirements ☒ E207 Software Requirements ☒ E208 Support Documentation and Services Requirements https://www.access-board.gov/ict/ https://www.access-board.gov/ict/

3.2 COMPATIBILITY WITH ASSISTIVE TECHNOLOGY

The standards do not require installation of specific accessibility-related software or attachment of an assistive technology device. Section 508 requires that ICT be compatible with such software and devices so that ICT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.

3.3 ACCEPTANCE AND ACCEPTANCE TESTING

Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.

The Government reserves the right to test for Section 508 Compliance before delivery.

The Contractor shall be able to demonstrate Section 508 Compliance upon delivery.

4.0 INFORMATION TECHNOLOGY USING SUSTAINABLE PRODUCTS AND

SERVICES

The Contractor shall comply with Sections 524 and Sections 525 of the Energy Independence and Security Act of 2007; Section 104 of the Energy Policy Act of 2005;

Executive Order 13221, “Energy-Efficient Standby Power Devices,” dated August 2, 2001; and the Federal Acquisition Regulation (FAR) to provide ENERGY STAR®, Federal Energy Management Program (FEMP) designated, and products and services that meet EPA Recommendations of Specifications, Standards, and Ecolabels in effect as of October 2023 (e.g. Electronic Product Environmental Assessment Tool (EPEAT) registered products) in providing information technology products and/or services. The Green Procurement Compilation (GPC) website available at Green Procurement Compilation - GSA Sustainable Facilities Tool (sftool.gov) provides a comprehensive list of sustainable products and services and sustainable acquisition guidance.

The Contractor shall provide products that meet the definition of sustainable products and services if the products are delivered to the Government; furnished by the Contractor for use by the Government, incorporated into the construction of a public building or public work, or acquired by the Contractor for use in performing services under a Government contract where the cost of the products is a direct cost to a Government contract (versus costs which are normally applied to a contractor's general and administrative expenses or indirect costs).

Specifically, the Contractor shall provide sustainable products under this contract IAW FAR 52.223-23. The applicable products with their associated certification, designation, and/or ecolabel (e.g. Energy Star, FEMP, and/or EPEAT) are identified within the product specifications in this PD. The Contractor shall ensure proposed products meet the certification(s) / designation(s) / ecolabel(s) specified at the time of submission of proposals and at the time of award.

5.0 SHIPMENT OF HARDWARE OR EQUIPMENT

Not applicable https://sftool.gov/greenprocurement https://sftool.gov/greenprocurement

6.0 GENERAL REQUIREMENTS

6.1 VA TECHNICAL REFERENCE MODEL

The Contractor shall comply with the VA OIT Technical Reference Model (VA TRM).

Compliance with the VA TRM is achieved by using only technologies and standards that are listed as approved for use in the VA TRM. The Contractor shall provide all necessary information requested by VA to ensure TRM approval is obtained prior to use on VA’s network.

6.2 ZERO TRUST – VA CRITICAL SECURITY CONTROLS

VA has established minimum mandatory security requirements and requires that any network connected software system or service must meet the VA Critical Security Controls as outlined in the VA Memorandum, “VA Security Controls”, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010. VA Critical Security Controls identify the minimum mandatory requirements that must be implemented across all VA enterprise infrastructure, cloud computing environments, information systems, networks, and specialized devices (medical devices/systems, special-purpose systems, and research scientific computing devices) that process, store, and/or transmit VA data. Effective July 1, 2025, the Contractor shall implement these VA Critical Security Controls, within any network connected software system or service prior to being authorized for use in the VA. This functional requirement is not negotiable, and Plan of Action & Milestones will not be accepted in the event these controls cannot be implemented for new systems. Critical Security Controls are intended to increase VA’s security posture and provide security and privacy risk visibility into the VA network and is not a new requirement. The Contractor’s failure to maintain these VA Critical Controls after implementation will result in VA discontinuing the use of the system.

6.3 SOCIAL SECURITY NUMBER (SSN) REDUCTION

The Contractor solution shall support the Social Security Number (SSN) Fraud Prevention Act (FPA) of 2017 which prohibits the inclusion of SSNs on any document sent by mail. The Contractor support shall also be performed IAW Section 240 of the Consolidated Appropriations Act (CAA) 2018, enacted March 23, 2018, which mandates VA to discontinue using SSNs to identify individuals in all VA information systems as the Primary Identifier. The Contractor shall ensure that any new IT solution discontinues the use of SSN as the Primary Identifier to replace the SSN with the Integrated Control Number (ICN) in all VA information systems for all individuals. The Contractor shall ensure that all Contractor delivered applications and systems integrate with the VA Master Person Index (MPI) for identity traits to include the use of the ICN as the Primary Identifier. The Contractor solution may only use a Social Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA.

https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010

6.4 INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support IPv6-Only based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). Which defines IPv6-only as the state of an operational system or service when IPv4 protocol functions (addressing, packet forwarding) are not in use. The NIST USGv6 profile defines technical requirements for a product to be capable of operating in IPv6-Only environments. IPv6-Only technology, IAW the USGv6 Program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices, applications, and systems shall support all applicable functionality on native IPv6-Only as well as dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g., web, email, DNS, ISP services, etc.) shall support native IPv6-Only and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall support using native IPv6-Only and dual stack (IPv6 / IPv4) for all functionality and operations.

6.5 SOFTWARE AND LICENSING REQUIREMENTS

The Contractor shall be responsible for the provision of all software licenses and any associated licensing maintenance required for any development, delivery, integration, operation, and/or maintenance associated with its proposed application(s), software products, software solution, and/or system including, but not limited to, any and all application(s), software and/or software products that comprise, are a part of, or integrate with the Contractor’s proposed application(s), software products, software solution, and/or system for the life of any resulting contract.

6.6 TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative“ (https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf), VA Directive 6513 “Secure External Connections”, and shall comply with the TIC 3.0 Core Guidance Documents, including all Volumes and TIC Use Cases, found at the Cybersecurity & Infrastructure Security Agency (CISA) (https://www.cisa.gov/publication/tic-30-core-guidance-documents.)

6.7 POSITION/TASK RISK DESIGNATION LEVEL(S)

IAW VA Handbook 0710, Personnel Security and Suitability Program, the position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are:

https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1 https://doi.org/10.6028/NIST.SP.500-267Br1 https://doi.org/10.6028/NIST.SP.800-119 https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf https://www.cisa.gov/publication/tic-30-core-guidance-documents

Position Sensitivity and Background Investigation Requirements by Service Task/Item Number

Service Task / Item Number

Tier1 / Low Risk Tier 2 / Moderate Risk

Tier 4 / High Risk

1.1 (including all sub-paragraphs) ☒ ☐ ☒

2.0 ☐ ☐ ☒

The Tasks identified above and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, IAW their submitted proposal.

7.0 POINTS OF CONTACT

VA Program Manager:

Name: Provided at time of award Address:

Voice:

Email:

Contracting Officer’s Representative (COR):

Name: Provided at time of award Address:

Voice:

Email:

Contracting Officer:

Name: Provided at time of award Address:

Voice:

Email:

Contract Specialist:

Name: William Waterhouse Address: 23 Christopher Way, Eatontown, NJ 07724 Voice: 848.377.5097 Email: William.Waterhouse@va.gov

ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM SECURITY/

PRIVACY LANGUAGE

NOTE: In the event of a conflict, VAAR Security Clauses take precedence over the language in this Addendum B.

APPLICABLE SECTIONS FROM: VA NOTICE 24-12, APRIL 22, 2024, UPDATE TO

VA HANDBOOK 6500.6, CONTRACT SECURITY, APPENDIX C VA INFORMATION

AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE, FOR INCLUSION

INTO CONTRACTS, AS APPROPRIATE

B1. GENERAL

This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, Subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

B2. VA INFORMATION CUSTODIAL LANGUAGE

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this Contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the Contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, PWS, PD, and/or contract. The Contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the Contractor’s information systems or media storage systems. The Contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of Contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The Contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to Contractor and Subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government

Accountability Office staff during periodic control assessments, audits, or investigations.

e. The Contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The Contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed IAW VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a VHA contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken IAW VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contractor.

h. The Contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The Contractor shall transmit VA sensitive information using VA approved Transport Layer Security configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security Implementations.

i. The Contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the Contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO.

The Contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the Contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality-assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus . If the Contractor is in receipt of a court order or other requests for the above-mentioned information, the Contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the Contractor by VA for the performance or administration of this contract or information developed by the Contractor in performance or administration of the contract will be protected and secured IAW VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a Contractor shall be done IAW National Archives and Records Administration requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The Contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the Contracting Officer’s Representative (COR)/CO, the Contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The Contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the Contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the Contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.)

used to store, process or access VA information will not be returned to the Contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

B3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A Contractor/Subcontractor shall request logical (technical) or physical access to

VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of Contractor/Subcontractor and agent of Contractor/Subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior before access is provided to VA information and information systems (see Section 4, Training, below). The Rules of Behavior contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All Contractors and Subcontractors working with VA information are subject to the same security investigative and clearance requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors shall be IAW VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual.

d. All Contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All Contractors and Subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the Contractor must state where all non-U.S. services are provided. The Contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The Contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/Subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/Subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or Subcontractor personnel may pose a threat to their company’s working environment or to any company-owned property. This includes Contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to Contractor/Subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/Subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which Contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for Contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the Contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by Contractor/Subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens.

Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/Subcontractors who no longer require VA accesses will return VA-issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, Contractors shall notify the appropriate VA COR/CO.

B4. TRAINING

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role-based information security training].

b. The Contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

B5. SECURITY INCIDENT INVESTIGATION

a. The Contractor, Subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711).

The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the Contractor, Subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the Contractor/Subcontractor, the Contractor/Subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the Contractor is taking to ensure no future incidents of a similar nature.

c. After the Contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The Contractor, Subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT Contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. In instances of theft or break-in or other criminal activity, the Contractor / Subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG, and the VA Office of Security and Law Enforcement. The Contractor, its employees, and its Subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The Contractor / Subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

f. The Contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the Contractor is deemed to have discovered a data breach when the Contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made IAW the executed BAA.

h. If the Contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the Contractor/Subcontractor processes or maintains under the contract; the Contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages— Reimbursement for Data Breach Costs.

B6. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations IAW FIPS 199, Standards for Security Categorization of Federal Information and Information Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems. Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA TIC Architecture).

b. Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information Security Knowledge Service to obtain an ATO. VA Directive 6517, Risk Management Framework for Cloud Computing Services, provides the security and privacy requirements for cloud environments.

c. VA IT Contractors, Subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the Contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution.

Contractors shall comply with FAR 39.1, specifically the prohibitions referenced.

d. The Contractor (including producers and resellers) shall comply with OMB M-22- 18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M-22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application https://www.va.gov/oal/library/vaar/vaar852.asp#85221176 https://www.va.gov/oal/library/vaar/vaar852.asp#85221176 services (e.g., cloud-based software), as well as products containing software.

The Contractor shall provide a self-attestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified FedRAMP 3PAO or one approved by the agency will be acceptable in lieu of a software producer's self-attestation.

e. The Contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive 12 and VA Identity and Access management enterprise identity management requirements as set forth in OMB M-19-17, M-05-24, FIPS 201-3, PIV of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The-Shelf product(s) that the Contractor did not develop, all software configurations and all customizations.

f. The Contractor shall ensure all Contractor delivered applications and systems provide user authentication services compliant with VA Handbook 6500, VA Information Security Knowledge Service, IAM enterprise requirements and NIST 800-63, Digital Identity Guidelines, for direct, assertion-based authentication and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure based authentication supportive of PIV and/or Common Access Card, as determined by the business need and compliance with VA Information Security Knowledge Service specifications.

g. The Contractor shall use VA authorized technical security baseline configurations and certify to the COR that applications are fully functional and operate correctly as intended on systems in compliance with VA baselines prior to acceptance or connection into an authorized VA computing environment. If the Defense Information Systems Agency has created a Security Technical Implementation Guide (STIG) for the technology, the Contractor may configure to comply with that STIG. If VA determines a new or updated VA configuration baseline needs to be created, the Contractor shall provide required technical support to develop the configuration settings. FAR 39.1 requires the population of operating systems and applications includes all listed on the NIST National Checklist Program Checklist Repository,

h. The standard installation, operation, maintenance, updating and patching of software shall not alter the configuration settings from VA approved baseline configuration. Software developed for VA must be compatible with VA enterprise installer services and install to the default “program files” directory with silently install and uninstall. The Contractor shall perform testing of all updates and patching prior to implementation on VA systems.

i. Applications designed for normal end users will run in the standard user context without elevated system administration privileges.

j. The Contractor-delivered solutions shall reside on VA approved operating systems. Exceptions to this will only be granted with the written approval of the

COR/CO.

k. The Contractor shall design, develop, and implement security and privacy controls IAW the provisions of VA security system development…