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DA10--Intent to Sole Source Nuance Powerscribe ONE 2019 Upgrade
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36C24126Q0143
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This is a Specification/Statement of Work (SOW) for an upgrade to the Nuance Powerscribe 360 Radiology Voice Recognition System for VISN 1 (Veterans Integrated Service Network 1). The contract is a sole-source procurement to provide a comprehensive voice recognition dictation system (VRDS) with integration to the Picture Archive and Communications System (PACS) for multiple VA healthcare facilities across New England, including locations in Massachusetts, Connecticut, Rhode Island, Maine, and other states.

Key requirements include a hybrid cloud-based system with FedRAMP approval, 99.99% uptime, and the ability to handle multi-specialty exams (currently 320,000 per year with a 5% expected growth rate). The system must support customizable report templates, accommodate various diagnostic codes, provide migration services for existing reports, and include hardware, software, ongoing upgrades, training, and technical support. The contract is structured as a one-year base with options to extend for four additional years, with the contractor responsible for comprehensive security, privacy, and compliance measures throughout the contract period.

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SPECIFICATION/STATEMENT OF WORK

Upgrade to VISN 1 Nuance Powerscribe 360 Radiology Voice Recognition System to Powerscribe

One 2019

I. Background

The purpose of this sole source contract is to provide VISN 1 with an upgrade to the current radiology voice recognition dictation system (VRDS) and its integration with radiology Picture Archive and

Communications System (PACS) to include software, hardware, training, and support. VISN 1 is comprised of the following locations: VA Boston Healthcare System (Jamaica Plain, West Roxbury, Brockton), Bedford VA Healthcare System, Central Western Massachusetts VA Healthcare System

(Leeds and Worcester), Connecticut VA Healthcare System (West Haven, Newington), Providence VA

Healthcare System, Manchester VA Healthcare System, White River Junction VA Healthcare System and

Maine VA Healthcare System (Togus/Augusta/Portland).

VISN 1 is currently providing Radiology services utilizing a hub and spoke PACS model spread across numerous states and Veterans Hospitals and Health Centers.

VISN 1 completes an average of 320,000 multi-specialty exams per year. The expected growth rate assumed to be 5% on a yearly basis.

II. Objectives

A. An overview of this SOW will include the following goals and objectives; VISN 1 has a critical need to utilize a VRDS that integrates with PACS where all exams performed at any single site are available for dictation at all sites within the VA New England Network. The system will have high reliability and multiple redundancies (back up and disaster recovery and/or FedRamp approved cloud storage). The system will have built in and customizable report templates that can be shared across the system. The system will accommodate all current and future “diagnostic codes” to include but not limited to BiRads, PiRads, LungRads, and VA customized codes.

III. Scope, Tasks, or Requirements

A. The general scope of the work the contractor will be performing is to supply a comprehensive

VRDS solution to include all hardware, software, on-going upgrades, training, and technical support, including current and future integration services.

B. If required, the contractor will provide migration services for all existing reports and templates in the current legacy VRDS.

C. The preferred configuration will be through the use of a hybrid cloud environment (Must be

FedRamp approved such as AWS fedCloud). The system should also be configured in such a way that software, storage, servers or other upgrades can be performed with no or minimal impact to end users. The goal is to maintain a 99.99% up-time.

D. On-going upgrades and hardware refresh will be performed in an expeditious manner with minimal impact to the daily operations of the radiology service. All installed upgrades will first be FDA approved and vetted in the field (test environment) for compatibility with the VISN 1

Electronic Medical Record (EMR) and currently interfaced third party vendors. Installation of software upgrades will be staged and planned so that all sites are upgraded within no more than a three (3) month period.

E. On-going Integration Services will be provided to include integration with third party medical devices and software as they are acquired and implemented by the VA.

F. The VRDS software will provide administrative management tools for report correction, user management, system and user monitoring.

Installation:

Offeror must install core VRDS in a primary and redundant data center or Cloud environment.

These data centers shall include the following.

• Unlimited dictation licenses and voice profiles.

• Integration with DICOM Modality Worklist Solution (DMWL) such that VRDS can synchronize with and drive PACS and vice versa.

• Business Analytics to offer analysis to the VISN across all sites defined in the sites listing.

• Professional Services to accomplish the installation, training, workflow analysis of the vendors solution.

• Engineering to accomplish the integrations and configurations for LDAP with PIV smart card login, URL redirects, and the specialty viewers. Including Go-Live support.

• Quality Design Module- this module shall include workflows that manage and monitor quality, such as Peer Review, image quality reporting, etc.

V. Delivery Schedule

A. Upon award the contractor will work with VISN 1 to establish a timeline for installation, migration, and cutover from the legacy PACS, B. Within 10 business days of award the government will conduct a post award conference with the awardee and the field representatives

VI. Government-Furnished Equipment and Government-Furnished Information

A. The VA-VISN 1 will furnish server space, electrical and environmentals as needed to meet the specifications of the vendor provided hardware.

B. The VA-VISN 1 will provide network infrastructure (speed and access will be governed by OI&T and may be subject to limitations), network security/isolation instructions and structure, IP and naming conventions, and other networking/security assistance and instruction as required for project implementation.

VII. Security

A. The VRDS will conform with all current VA required network and patient information security.

It will be the contractor’s responsibility to stay abreast of all current and future changes to this requirement.

B. The Contractor is required to assure all personnel working on or remotely servicing the VRDS meet VA security requirements and have been vetted through the appropriate channels. Please refer to VA Directive 6500, Cyber Security Program. The publication is located at https://www.va.gov/vapubs/search_action.cfm?dType=1

C. Remote connectivity and active system monitoring will conform to VA requirements and will be the responsibility of the contractor to monitor and maintain.

D. It has been determined that protected health information (PHI) may be used, disclosed, accessed, transmitted, created, stored/maintained, and/or destroyed (providing appropriate proof of destruction in compliance with VA Directive 6371) by the Contractor, and a signed Business Associate Agreement (BAA) will be required. The Contractor will adhere to the requirements set forth within the BAA, referenced in the solicitation, and will comply with all applicable VA/VHA Directives. Once awarded, Contractor and Contracting Officer will collaborate with the appropriate VISN Privacy Officer to implement the appropriate BAA.

E. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY

SECURITYREQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

F. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract

VIII. Place of Performance

A. This work will be performed at a government site, specifically at the VAMC facilities within the

VA New England Healthcare Network (VISN 1)

IX. Period of Performance

A. The period of performance for this requirement is a one (1) year base with the option to extend the term of the contract for an additional four (4) years. The exercise of the options is subject to the availability of funds and will be exercised utilizing FAR Clause 52.217-9, Option to Extend the Term of the Contract. .

B. Work will be performed 365/24/7 with the goal of providing 99.99% up-time with minimal impact to normal hours of operation (M-F 0700-2200 hrs.)

C. Service calls will be answered by a qualified remote (US based) support technician within 15 minutes of the initial call with an escalation process if resolution is not achieved within 1 hour.

X. Contractor’s Responsibility

A. Contractor will provide qualified support personnel with familiarity and knowledge of VA network and security requirements.

B. The Contractor will be responsible for all software and hardware updates and upgrades during the performance period of this contract.

C. The contractor is responsible for keeping equipment in good working order and shall provide all maintenance, repairs, and upgrades to the equipment as required keeping it in optimal condition.

D. The Contractor will provide services in accordance with ethical, professional and technical standards of the health care industry.

XI. Services Not Covered

A. Any work other than as specified in the contract shall be identified as a non-priced task, and if determined by the Contracting Officer to be within the overall scope of the contract, work shall be added by a modification to the contract.

B. Any work requested that is identified as outside the scope of the contract shall be addressed by the facility as a separate procurement.

XII. Federal Holidays Observed By The VA

New Year's Day 1 January Labor Day 1st Mon. in Sept

M L King's Birthday 3rd Mon. in Jan Columbus Day 2nd Mon. in Oct

President's Day 3rd Mon. in Feb Veterans Day 11 November

Memorial Day Last Mon. in May Thanksgiving Day 4th Thurs. in Nov

Juneteenth 19 June

Independence Day 4 July Christmas Day 25 December

1. Also included would be any other day specifically declared by the President of the United States to be a National Holiday.

2. When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by

U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday.

XIII. Identification, Parking, Smoking, and VA Regulations:

A. The Contractor's FSEs shall wear visible identification at all times while on the premises of the

VAMC. It is the responsibility of the contractor to obtain and pay for parking as may or may not be required. The VAMC does not guarantee on-site parking. The VAMC will not invalidate or make reimbursement for parking violations or charges for the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC and only in designated areas on campus. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

XIV. Orientation For Contractor Employees

A. Contractor will attend an orientation meeting as arranged by the Contracting Officer’s

Representative (COR) on-line or other written training may be substituted at the discretion of the

COR.. The VA will schedule this meeting and it will include discussion of the following topics:

(VA will provide information to the contractor regarding these topics and will document the meeting)

1. Fire and Safety

2. Infection control

3. Disaster procedures

4. Other

B. The Contractor will be responsible to ensure that Contractor employees coming to the work site will receive the information required above.

C. The Contractor will be responsible to ensure Contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

XV. Contractor Personnel Security Requirements:

All contractor employees who require access to the Department of Veterans Affairs' Contractors computer systems or have access to sensitive information shall be the subject of a background investigation. The contractor is encouraged to have its employee immediately download the background investigation packet from http://www.osp.va.gov/Security_and_Investigations_Center_FF.asp upon notification of contract award. A contractor’s employee shall not commence working at VA under contract until the Contracting

Officer receives notification from the VA Office of Security and Law Enforcement that the contract employee’s application was received complete. A favorable adjudication from the VA Office of Security and Law Enforcement must be received in order for a contractor employee to continue contract performance. This requirement is applicable to all subcontractor personnel.

a. Position Sensitivity - The position sensitivity has been designated as low risk.

b. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries (NACI).

c. Contractor Responsibilities

1. The contractor shall bear the expense of obtaining background investigations. If the Office of

Personnel Management (OPM) conducts the investigation, the contractor shall reimburse VA within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractors 1st month’s invoice(s) for services rendered.

2. It is imperative for the contractor to provide, at the request of VA, a listing of contractor personnel performing services under the contract in order for the background investigation process to commence. This list will include name (first, middle, last) social security number; date of birth; city, state, and country of birth.

3. The contractor or their employees shall submit a complete background investigation packet.

Additional guidance and information in completing the required forms, and examples of the forms, can be found at http://www1.va.gov/VABackground_Investigations/page.cfm?pg=2.

http://www.osp.va.gov/Security_and_Investigations_Center_FF.asp http://www1.va.gov/VABackground_Investigations/page.cfm?pg=2

7. All contractor employees and subcontractors are required to complete VA’s Privacy training annually. All Contractor employees and subcontractors requiring access to VA computer network are required to complete Cyber Security training courses annually either on-line or hard copy. Documented proof must be provided to the Contracting Officer.

8. The contractor will notify the COR immediately when their employee(s) no longer require access to VA computer systems.

d. Government Responsibilities

1. The contracting officer will request the contractor employee’s background investigation by the

Office of Security and Law Enforcement.

2. The Office of Security and Law Enforcement will notify the contractor with instructions for the contractor's employees, coordinate the background investigations, and notify the contracting officer and contractor of the results of the investigations.

3. The VA facility will pay for requested investigations in advance. A bill for collection will be sent to the contractor to reimburse the VA facility. The contractor will reimburse the VA facility within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractors 1st month’s invoice(s) for services rendered.

4. The current fees associated with background investigations are $210.00 each for low level investigation, $850.00 each for medium level investigation, and $2,900.00 each for high level investigation.

XVI. Security Training

Due to the increased emphasis on privacy and information security, the following special contract requirements are established and hereby made part of the contract entered into with the Department of

Veterans Affairs.

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].

a. 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.

b. 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.

XVII. Access to VA Information and VA Information Systems

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

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.

XVIII. 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 contactor.

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.

XIX. 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 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. 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 in accordance with the provisions of VA security system development life cycle outlined in NIST 800-37, Risk Management

Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and

Privacy, VA Directive and Handbook 6500, and VA Handbook 6517.

l. The Contractor shall comply with the Privacy Act of1974 (the Act), FAR 52.224-2 Privacy Act, and

VA rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish a VA function.

m. The contractor shall ensure the security of all procured or developed information systems, systems, major applications, minor applications, enclaves and platform information technologies, including their subcomponents (hereinafter referred to as “Information Systems”) throughout the life of this contract and any extension, warranty, or maintenance periods. This includes security configurations, workarounds, patches, hotfixes, upgrades, replacements and any physical components which may be necessary to remediate all security vulnerabilities published or known to the contractor anywhere in the information systems (including systems, operating systems, products, hardware, software, applications and firmware).

The contractor shall ensure security fixes do not negatively impact the Information Systems.

n. When the contractor is responsible for operations or maintenance of the systems, the contractor shall apply the security fixes within the timeframe specified by the associated controls on the VA Information

Security Knowledge Service. When security fixes involve installing third party patches (such as Microsoft

OS patches or Adobe Acrobat), the contractor shall provide written notice to the VA COR/CO that the patch has been validated as to not affecting the Systems within 10 business days.

XX. Security Incident Investigation

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.

XXI INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE

a. The contractor shall comply with all Federal laws, regulations, and VA policies for Information systems (cloud and non-cloud) that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities. Security controls for collecting, processing, transmitting, and storing of VA sensitive information, must be in place. The controls will be tested by VA or a VA sanctioned 3PAO and approved by VA prior to hosting, operation, maintenance or use of the information system or systems by or on behalf of VA. This includes conducting compliance risk assessments, security architecture analysis, routine vulnerability scanning, system patching, change management procedures and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures shall be the same as procedures used to secure VA-operated information systems.

b. Outsourcing (contractor facility, equipment, or staff) of systems or network operations, telecommunications services or other managed services require Assessment and Authorization (A&A) of the contractor’s systems in accordance with VA Handbook 6500 as specified in VA Information Security

Knowledge

Service. Major changes to the A&A package may require reviewing and updating all the documentation associated with the change. The contractor’s cloud computing systems shall comply with FedRAMP and

VA Directive 6517 requirements.

c. The contractor shall return all electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) on non-VA leased or non-VA owned IT equipment used to store, process or access VA information to VA in accordance with A&A package requirements. This applies when the contract is terminated or completed and prior to disposal of media. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Information Security Knowledge Service requirements and NIST

800-88. The contractor shall send a self-certification that the data destruction requirements above have been met to the COR/CO within 30 business days of termination of the contract.

d. All external internet connections to VA network involving VA information must be in accordance with

VA Trusted Internet Connection (TIC) Reference Architecture and VA Directive and Handbook 6513, Secure External Connections and reviewed and approved by VA prior to implementation. Government-owned contractor-operated systems, third party or business partner networks require a Memorandum of

Understanding (MOU) and Interconnection Security Agreements (ISA).

e. Contractor procedures shall be subject to periodic, announced, or unannounced assessments by VA officials, the OIG or a 3PAO. The physical security aspects associated with contractor activities are also subject to such assessments. The contractor shall report, in writing, any deficiencies noted during the above assessment to the VA COR/CO. The contractor shall use VA’s defined processes to document planned remedial actions that address identified deficiencies in information security policies, procedures, and practices. The contractor shall correct security deficiencies within the timeframes specified in the VA

Information Security Knowledge Service.

f. All major information system changes which occur in the production environment shall be reviewed by the VA to determine the impact on privacy and security of the system. Based on the review results, updates to the Authority to Operate (ATO) documentation and parameters may be required to remain in compliance with VA Handbook 6500 and VA Information Security Knowledge Service requirements.

g. The contractor shall conduct an annual privacy and security self-assessment on all information systems and outsourced services as required. Copies of the assessment shall be provided to the COR/CO. The

VA/Government reserves the right to conduct assessment using government personnel or a third-party if deemed necessary. The contractor shall correct or mitigate any weaknesses discovered during the assessment.

h. VA prohibits the installation and use of personally owned or contractor-owned equipment or software on VA information systems. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW, PWS, PD or contract. All security controls required for government furnished equipment must be utilized in VA approved Other Equipment (OE).

Configuration changes to the contractor OE, must be funded by the owner of the equipment. All remote systems must use a VA-approved antivirus software and a personal (host-based or enclave based) firewall with a VA-approved configuration. The contractor shall ensure software on OE is kept current with all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-virus software and the firewall on the non-VA owned OE. Approved contractor OE will be subject to technical inspection at any time.

i. The contractor shall notify the COR/CO within one hour of disclosure or successful exploits of any vulnerability which can compromise the confidentiality, integrity, or availability of the information systems. The system or effected component(s) need(s) to be isolated from the network. A forensic analysis needs to be conducted jointly with VA. Such issues will be remediated as quickly as practicable, but in no event longer than the timeframe specified by VA Information Security Knowledge Service. If sensitive personal information is compromised reference VA Handbook 6500.2 and Section 5, Security

Incident Investigation.

j. For cases wherein the contractor discovers material defects or vulnerabilities impacting products and services they provide to VA, the contractor shall develop and implement policies and procedures for disclosure to VA, as well as remediation. The contractor shall, within 30 business days of discovery, document a summary of these vulnerabilities or defects. The documentation will include a description of the potential impact of each vulnerability and material defect, compensating security controls, mitigations, recommended corrective actions, root cause analysis and/or workarounds (i.e., monitoring).

Should there exist any backdoors in the products or services they provide to VA (referring to methods for bypassing computer authentication), the contractor shall provide the VA CO/CO written assurance they have permanently remediated these backdoors.

k. All other vulnerabilities, including those discovered through routine scans or other assessments, will be remediated based on risk, in accordance with the remediation timelines specified by the VA Information

Security Knowledge Service and/or the applicable timeframe mandated by Cybersecurity & Infrastructure

Security Agency (CISA) Binding Operational Directive (BOD) 22-01 and BOD 19-02 for Internet-accessible systems. Exceptions to this paragraph will only be granted with the approval of the COR/CO.

XXII. Liquidated Damages for Data Breach

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the

Security Incident Investigation section above. Upon such notification, VA must secure from a non-

Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the…

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