Diameter Health Availity PD.pdf

PRODUCT DESCRIPTION (PD)

DEPARTMENT OF VETERANS AFFAIRS

Office of Information & Technology Office of Health Informatics (OHI)

Brand Name Diameter Health

Availity Clinical Care Document (CCD) Analyzer Software Licenses, Operational Support and Maintenance Support, Data Quality Tool (DQT)

Date: February 25, 2025

VA-25-00011523

PD Version Number: 1.0

Diameter Health/Availity CCD Analyzer Software Licenses and Maintenance Support, DQT

TAC Number: VA-25-00011523

Contents

1.0 PRODUCT REQUIREMENTS

2.0 NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL

INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS

(SECTION 508)

2.1 SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY (ICT)

STANDARDS

2.2 COMPATABILITY WITH ASSISTIVE TECHNOLOGY

2.3 ACCEPTANCE AND ACCEPTANCE TESTING

3.0 INFORMATION TECHNOLOGY USING ENERGY-EFFICIENT PRODUCTS

3.1 EPEAT

3.2 ENERGY STAR

3.3 FEMP

4.0 SYSTEM ACCEPTANCE (PRE-PRODUCTION) TESTING

N/A 10

5.0 SHIPMENT OF HARDWARE OR EQUIPMENT

N/A 10

5.1 SPECIAL SHIPPING INSTRUCTIONS

N/A 10

5.2 NATIONAL ACQUISITIONS

N/A 10

6.0 GENERAL REQUIREMENTS

6.1 VA TECHNICAL REFERENCE MODEL

6.2 SOCIAL SECURITY NUMBER (SSN) REDUCTION

6.3 INTERNET PROTOCOL VERSION 6 (IPV6)

6.4 SOFTWARE AND LICENSING REQUIREMENTS

6.5 POSITION/TASK RISK DESIGNATION LEVEL(S)

6.6 GOVERNMENT FURNISHED PROPERTY

7.0 POINTS OF CONTACT

8.0 INFORMATION SECURITY CONSIDERATIONS:

ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM SECURITY/

PRIVACY LANGUAGE

1.0 PRODUCT REQUIREMENTS

The Department of Veterans Affairs (VA) has a requirement for renewal of brand name Diameter Health/Availity licenses, and a requirement brand name Diameter Health/Availity professional support service. These licenses and services are currently captured as the commercially available Diameter Health/Availity Clinical Care Document (CCD) Analyzer Enterprise Bundle and the Diameter Health/Availity Enterprise Operational Support Bundle. These services include, but are not limited to, set up of the environment, configuration services, software maintenance, and maintenance of ATO for the hosting environment. The Data Quality Tool (DQT) is based on Commercial-off-the-Shelf (COTS) software, specifically using the brand name Diameter Health/Availity Clinical Care Document (CCD) Analyzer and the Diameter Health/Availity Fusion software. The software license shall include these Diameter Health/Availity software products which are running in the current DQT system and will cover the operational system and testing instances regardless of the environment. The DQT shall be available 99.9% of the time.

The following Diameter Health/Availity brand name products are required:

Brand Name Product Part number Quantity

Diameter Health /Availity Clinical Care Document (CCD) Analyzer Enterprise Bundle Services include implementation support, training, technical support and maintenance

DHCCDBN20161Y 1

Diameter Health/Availity Enterprise Operational Support Bundle

DHCCDA20223Y 1

The DQT is utilized to measure the quality of health documents exchanged with VA partners. To provide care for Veterans, VA must send documents to and receive documents from various third-party providers. The quality of the documents exchanged has a direct impact on the quality of Veterans’ care. Additionally, the ability to measure and track changes to quality across different segments is critical to continuously improving care. The documents being measured for quality are based on industry standards developed by Health Level Seven’s (HL7s) and the Healthcare Information Technology Standards Panel.

NOTE OF CLARIFICATION: The information being sent using the API is from the Oracle Health jHIE to Availity based on the jHIE Agg CCD (disclosed) and external data (received).

The DQT system is currently integrated with other VA systems via the application programing interface (API) that is part of the Diameter Health/Availity product to receive information from the Joint VA and Department of Defense (DoD) Health Information Exchange (JHIE) in use at VA.

Management of this system and its interfaces requires several instances of the system to support different kinds of analysis and testing. These needs include testing for system interfaces and testing of business rules. The software license must cover any needed testing instances and non-production instances of the system.

The Contractor shall provide Standard Maintenance & Technical Support which includes the following:

a) Telephone and online technical support during standard (peak) business hours (Monday – Friday, 9 am – 5 pm ET) and non-peak hours of inoperation. The Contracted Project Manager is provided a list of resources, titles, competency areas and telephone numbers of individuals within its technical support organization for problem response escalation.

b) High priority online support, connected to the VA network, will support the response to VA system outages and incidents. If the DQT system becomes non-operational, then the Contractor will provide the individual(s) necessary to restore the system consistent with VA Change Control and Incident Management policies. For major incidents, the VA may have an incident commander leading the response activities across multiple product teams.

c) Maintenance releases, including all upgrades, updates and fixes, which Diameter Health/Availity makes generally available (at no additional charge) to its Maintenance & Support customers. Software problem diagnosis and resolution.

d) Telephone, remote support and/or e-mail assistance to support the implementation of the Software for installation of significant maintenance releases of software versions, updates or upgrades

e) Prompt feedback and guidelines necessary for tracking reported Software maintenance and technical support issues.

The Contractor shall maintain an audit log of system activity, user access and configuration changes. This data shall be entered into Jira, Change Control template, Service Now or other VA systems as appropriate. The Diameter Health/Availity CCD Analyzer Enterprise Bundle shall include professional support services to enable VA to successfully analyze and score documents and make recommendations to constituents. The Contractor shall have one or more employees who are active and expert in HL7 standards workgroups related to C-CDA standards. The DQT supports VA’s effort to improve the quality of information provided by scoring and validating the documents’ syntactic structure and semantic meaning to determine both completeness and correctness. The DQT shall provide a meaningful score and list of issues for each document and present both document level and aggregated results in a dashboard.

NOTE – Historically references to management of the new rule development, Natural Language Processing (NLP) management were included. The solution shall provide the following: functional, technical, and non-functional characteristics:

• Enable data transformation, processing and normalization of both structured and unstructured data contained in the documents. This includes the ability to add normalized data to original documents that represent the original data in a more usable form (e.g., decompose a free-text sig into form, route, frequency, etc.). Any changes to the original document must be clearly identified as to the source, type and time of change.

• Produce graded reports for individual and batches of documents with ratings for document syntactical accuracy, semantic accuracy and completeness.

• Produce graded reports for batches of documents with ratings for document syntactical accuracy, semantic accuracy and completeness in aggregated manner. If some documents cannot be graded for an attribute, reports shall indicate the quantity not scored.

• Identify duplicate data entries.

• Provide links to HL7 Standards or other specifications that are violated.

• Provide links to source documents’ locations where the HL7 violations were found.

• Include rules for validating syntax, semantic best practices. Rules shall:

o Perform logical testing of clinical data (e.g., chronic conditions should not be labeled as resolved).

o Perform time testing (e.g., examination of time stamps for clinical data reasonableness – event happening before date of birth).

o Assess the appropriate usage of standard terminologies.

o Validate free-text references, concepts and reference labels between narrative blocks and structured entries.

o Scan for common terminology and other miscoded entries.

o Distinguish between critical and minor issues.

o Group issues affecting readability vs. computability so that the user can focus first on either human readable or computable issues.

• Provide multiple ways to assess completeness, including o Number of sections populated in a document.

o Number of entries per section.

o Number of data fields per entry.

o Completeness of required vs. optional sections

• Evaluation and scoring should apply to all sections of Consolidated-Clinical Document Architecture (C-CDA) templates, including by way of example problems, results, social history, procedures, immunizations, payers, plan of care, care team, allergies, medications, and encounters.

• Enable automation of data quality surveillance and improvement of documents by providing Application Programming Interfaces (APIs) and Software Development Kits (SDKs) for integration with VA systems.

• Securely transport, process and store VA data compliant with federal statutes and regulations (i.e., Health Insurance Portability and Accountability Act (HIPAA)) regarding electronic protected health information (ePHI)

• Provide a web-based, graphical user interface:

o To weight and configure rules, including to turn off and disable rules o To upload single documents o To upload multiple documents in a single action.

o Display data quality scores in dashboards for both single and multiple document submissions.

• Present scores in dashboards segmented by major document sections (e.g., allergies, immunizations, medications, problems, procedures, results, social history, vital signs).

• Display human-readable information parsed from unstructured data in the documents.

• Provide case-specific actionable tips and user resources for best practices in interoperability.

• Facilitate communication of scores to different stakeholders (e.g., developers, clinician users, Standards Developing Organizations (SDOs)) with downloadable format reports (e.g. pdf), dashboard access.

The Data Quality Tool shall meet the following technical requirements.

• Compatible with Healthcare Information Technology Standards Panel (HITSP) C32, C64 and Health Level 7 (HL7) C-CDA version 1.1, 1.2 and 2.1 standards and future versions that are used within the Health Information Exchanges connected to VA.

• Support terminology from major vocabularies. (i.e. Systematized Nomenclature of Medicine (SNOMED) Clinical Terms (CT), International Classification of Diseases (ICD)-9, ICD-10, RxNorm, Logical Observation Identifiers, Names and Codes (LOINC)).

Product platform must support vendor integration & automated loading; the API output data must be in a computable format such as JavaScript Object Notation (JSON) format. Include a SDK to facilitate integration. These services include implementation support, training, technical support and maintenance.

Additionally, the contractor shall provide a refresher/ad hoc training program designed to provide users with the skills required to use the Diameter Health/Availity Analyzer and Fusion products. The vendor shall use a combination of in-person and web-based training techniques.

The DQT is currently operational with an Authority to Operate (ATO) granted by the VA as a FISMA moderate-risk system. Specifically, the contractor shall:

• Provide all Assessment and Authorization (A&A) support required to achieve and/or maintain full A&A certification in compliance with the most current versions of VA Handbook 6500, VA Handbook 6500.6 (Section 3), and VA Handbook 6500.3. The A&A process is the end-to-end process for ensuring new VA information systems adhere to and are in compliance with Federal Information Security Management Act (FISMA). The purpose of an Authority to Operate (ATO) is to ensure the risks to VA (operations, assets, or individuals) are acceptable. The result is the issuance of an ATO. If the risk to Agency operations, assets or individuals is low, an ATO authorizes the system to be moved into production or use production data.

• Provide updates to all Security and ATO documentation as needed.

• Support the Authority To Connect (ATC) documents, process, and activities with DoD. The ATC uses ATO documents and other security information to assess the security of an interface with a DoD system.

The VA Enterprise Cloud AWS GovCloud High (VAEC AWS) is a General Support System that provides a secure application and hosting environment for VA applications, content and utilities that are used to deliver content and applications to an audience made up of employees, veterans, contractors and partners across all VA medical centers and component facilities and the Federal government, veterans and the general public. The VAEC AWS GovCloud host DQT.

DQT will integrate with VDIF, JHIE and the new HIE Analytics system.

Deliverables:

A. DH Data Quality Tool Enterprise Bundle B. DH Enterprise Annual Pilot Hosting Bundle C. ATO Documentation

2.0 NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL

INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS

(SECTION 508)

On January 18, 2017, the Architectural and Transportation Barriers Compliance Board (Access Board) revised and updated, in a single rulemaking, standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by Section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. 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.

2.1 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: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines. A printed copy of the standards will be supplied upon request.

Federal agencies must comply with the updated Section 508 Standards beginning on January 18, 2018. The Final Rule as published in the Federal Register is available from the Access Board: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule.

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

2.2 COMPATABILITY 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 https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.

2.3 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.

3.0 INFORMATION TECHNOLOGY USING ENERGY-EFFICIENT PRODUCTS

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 13834, “Efficient Federal Operations”, dated May 17, 2018; 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, low standby power, and Electronic Product Environmental Assessment Tool (EPEAT) registered products in providing information technology products and/or services.

3.1 EPEAT

EPEAT product compliance is not required in this acquisition.

3.2 ENERGY STAR

Energy Star Compliance Is Not Required in This Acquisition.

3.3 FEMP

FEMP or FEMP low standby power product compliance is not required in this acquisition.

4.0 SYSTEM ACCEPTANCE (PRE-PRODUCTION) TESTING

N/A

5.0 SHIPMENT OF HARDWARE OR EQUIPMENT

N/A

5.1 SPECIAL SHIPPING INSTRUCTIONS

N/A

5.2 NATIONAL ACQUISITIONS

N/A

6.0 GENERAL REQUIREMENTS

6.1 VA TECHNICAL REFERENCE MODEL

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OIT Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OIT. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.

6.2 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 in accordance with 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.

6.3 INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support Internet Protocol Version 6 (IPv6) 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). IPv6 technology, in accordance with 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 shall support native IPv6 and 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 and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and dual stack (IPv6 / IPv4) operations.

6.4 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.

6.5 POSITION/TASK RISK DESIGNATION LEVEL(S)

In accordance with 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:

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

All

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 https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf file://///R04.med.va.gov/V03/EAS/Users/vhaeasWymbsk/TEMPLATES--NEW%20TAC%20PROCESS/PWS%20TEMPLATE%20(DO%20NOT%20TOUCH)%20-%20In%20Process%20Revisions/DO%20NOT%20TOUCH%20(next%20version/IPv6/(https:/www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1 file://///R04.med.va.gov/V03/EAS/Users/vhaeasWymbsk/TEMPLATES--NEW%20TAC%20PROCESS/PWS%20TEMPLATE%20(DO%20NOT%20TOUCH)%20-%20In%20Process%20Revisions/DO%20NOT%20TOUCH%20(next%20version/IPv6/(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

Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal.

6.6 GOVERNMENT FURNISHED PROPERTY

The Government has multiple remote access solutions available to include Citrix Access Gateway (CAG), Site-to-Site Virtual Private Network (VPN), and RESCUE VPN.

The Government’s issuance of Government Furnished Equipment (GFE) is limited to Contractor personnel requiring direct access to the network to: development environments; install, configure and run Technical Reference Model (TRM) approved software and tools (e.g., Oracle, Fortify, Eclipse, SoapUI, WebLogic, LoadRunner);

upload/download/ manipulate code, run scripts, and apply patches; configure and change system settings; check logs, troubleshoot/debug, and test/QA.

When necessary, the Government will furnish desktops or laptops, for use by the Contractor to access VA networks, systems, or applications to meet the requirements of this PWS. The overarching goal is to determine the most cost-effective approach to providing needed access to the VA environment coupled with the need to ensure proper Change Management principles are followed. Contractor personnel shall adhere to all VA system access requirements for on-site and remote users in accordance with VA standards, local security regulations, policies and rules of behavior. GFE shall be approved by the COR and Program Manager on a case-by-case basis prior to issuance.

Based upon the Government assessment of remote access solutions and requirements of this effort, the Government estimates that the following GFE will be required by this effort:

• 12 developer-grade laptops

The Government will not provide IT accessories including but not limited to Mobile Wi-Fi hotspots/wireless access points, additional or specialized keyboards or mice, laptop bags, extra charging cables, extra Personal Identity Verification card readers, peripheral devices, or additional Random Access Memory (RAM). The Contractor is responsible for providing these types of IT accessories in support of this effort as necessary and any VA installation required for these IT accessories shall be coordinated with the COR.

Additionally, the Contractor shall provide a monthly GFE status of all reportable GFE.

For purposes of this report, reportable GFE includes equipment that is furnished by the Government as tangible “personal” property which the Contractor takes possession of, physically leaves a Government facility, and needs to be returned the end of Contractor performance. The following information shall be provided for each piece of GFE:

1. Name of Contractor employee assigned to the GFE

2. Type of Equipment (Make and Model)

3. Tracking Number/Serial Number

4. VA Bar Code

5. Location

6. Value

7. Total Value of Equipment

8. Anticipated Transfer Date to Government

9. Anticipated Transfer Location

Deliverable:

A. GFE Report

7.0 POINTS OF CONTACT

VA Program Manager:

Name: TBD Address:

Voice:

Email:

Contracting Officer:

Name: Steven Snodgrass Address: 23 Christopher Way Eatontown, NJ 07724 Voice: 848-377-5043 Email: Steven.Snodgrass@va.gov

Contract Specialist:

Name: Michelle Policari Address: 23 Christopher Way Eatontown, NJ 07724 Voice: 848-377-5130 Email: Michelle.Policari@va.gov

8.0 INFORMATION SECURITY CONSIDERATIONS:

The Assessment and Authorization (A&A) requirements do apply and a Security Accreditation Package is required.

All VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this Product Description.

mailto:Michelle.Policari@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, SOW, 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 (GAO) 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 in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (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 in accordance with 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 (TLS) 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 (TLS) 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 (HIV). 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 in accordance with 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 in accordance with National Archives and Records Administration (NARA) 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 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 (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB 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 in accordance with 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 (NISPOM).

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 in accordance with 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 Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with 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 Trusted Internet Connections (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 Authority to Operate (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 Office of

Management and Budget (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 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 https://www.va.gov/oal/library/vaar/vaar852.asp#85221176 https://www.va.gov/oal/library/vaar/vaar852.asp#85221176 provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (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 (HSPD) 12 and VA Identity and Access management (IAM) enterprise identity management requirements as set forth in OMB M-19-17, M-05-24, FIPS 201-3, Personal Identity Verification (PIV) of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The-Shelf (COTS) 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 (PKI) based authentication supportive of PIV and/or Common Access Card (CAC), 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 (DISA) has created a Security Technical Implementation Guide (STIG) for the technology, the Contractor may configure to comply with that STIG.