S02 36C26125Q0914.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C261-26-AP-0402

640-26-2-230-0003

36C26125Q0914 08-29-2025

Edward Hunter 702 791-9000 x15197 09-12-2025

12:00PM PDT

36C261 Department of Veterans Affairs Network Contracting Office 21

X

513210

$47 Million

N/A

See Delivery Schedule

36C261

Financial Services Center P.O. Box 149971

Austin TX 78714-9971

See CONTINUATION Page

This solicitation is being procured in accordance with FAR Part 13.

Please carefully read provisions 52.212-1 instructions to Offerors and 52.212-2 Evaluation-Commercial Products and Commercial Services and submit your offer in accordance with these provisions.

Email your offer to Edward Hunter, edward.hunter@va.gov, by no later than the RFQ due date and time shown in box 8.

See CONTINUATION Page

Edward Hunter Contracting Officer

36C26125Q0914

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...40

C.4 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.5 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.8 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.9 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.10 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (MAY 2020)

C.11 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)

C.12 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.13 VAAR 852.239-70 SECURITY REQUIREMENTS FOR INFORMATION

TECHNOLOGY RESOURCES (FEB 2023)

C.14 VAAR 852.239-72 INFORMATION SYSTEM DESIGN AND DEVELOPMENT

(FEB 2023)

C.15 VAAR 852.239-73 INFORMATION SYSTEM HOSTING, OPERATION,

MAINTENANCE, OR USE (FEB 2023)

C.16 VAAR 852.239-74 SECURITY CONTROLS COMPLIANCE TESTING (FEB 2023)

C.17 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.18 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.6 VAAR 852.239-71 INFORMATION SYSTEM SECURITY PLAN AND

ACCREDITATION (FEB 2023)

E.7 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.8 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 2025)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon Government Inspection and Acceptance

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Procurement: Mammography Tracking System (MTS)

2. Background: The Statement of Work outlines the VA National Teleradiology Program (NTP) requirements for a mammography reporting and tracking system and ongoing service/support. NTP is the responsible program for VHA compliance with Public Law 117-135 – Making Advances in Mammography and Medical Options for Veterans Act Section 102, which established a tele-screening mammography program, and the MTS was an integral component to meeting the requirements of the Public Law.

In response to this solicitation, the vendor acknowledges understanding that NTP has substantial interface requirements between the proposed MTS, the Veterans Health Information and Systems Technology Architecture (VistA), Oracle Health’s (Cerner) Millennium electronic health record (EHR), artificial intelligence modules and Picture Archive and Communication Systems (PACS) and commits to ongoing updates/upgrades to maintain required integrations. Both MTS-driven and PACS VR-driven workflows shall be supported, with support for Structured Reporting (SR) and voice recognition (VR) templates. The Contractor shall provide all other software components.

During the contract, there will be ongoing workflow optimization to meet VHA clinical, operational and regulatory requirements and functionality of the MTS shall be updated/upgraded to meet those needs.

More specific requirements are defined below:

Item # Description

1 Mammography Tracking System to include results reporting

2 Concurrent user licenses and users: shall not be capped

3 HL7 integration with NTP VR (PS1)

4 HL7 interface and customization (ORM & ORU)

5 PACS Application Program Interface (API) to NTP PACS

Integration of breast density, risk, and quality data from NTP AI modules (Densitas AI application)

7 Tyrer-Cuzick Risk Assessment module

8 Screening mammogram cost/study to include remote service & support

3. Scope of Work: The contractor shall provide all the resources necessary to accomplish the deliverables described in this statement of work (SOW), except as otherwise specified. The contractor shall provide all necessary labor, management, supervision, technical skills, quality control, materials, parts, tools, transportation, and equipment necessary for the VA National Teleradiology Program (NTP) Mammography Tracking System identified below.

Table 1:

Base Requirements

Contract Year Description Estimate

Base Year

Deployment, testing, activation and end user training of MTS.

Base Year Integration with Densitas intelliMammo

Base Year Integration with PS1

Base Year

PACS workstation API 4

Base Year

Ongoing service/support to include system and client software updates and upgrades. Billed on a fee/study model for each parent mammography exam interpreted by NTP.

7,500 estimate

a. Multi-site mammography tracking system in support of the VA National Teleradiology Program’s Telescreening mammography program.

b. The MTS will initially support 4 different VA facilities with distinct organizational separation/access controls for each site. Client workstation licenses shall not be restricted.

James J. Peters VAMC Bronx, NY Louis A. Johnson VAMC Clarksburg, WV Ernest Childers Outpatient Clinic Tulsa, OK Oklahoma City VAMC Oklahoma City, OK

c. The MTS shall support application authentication using Single Sign-On (SSO) via PIV/CAC cards.

d. System-wide access across all sites to designated NTP interpreting physicians, the NTP Telescreening Mammography Director, the Assistant Director, and NTP PACS administrators.

e. The MTS will be hosted on VA-provided virtual servers on an isolated medical device virtual local area network (MD VLAN) according to VHA Medical Device Protection Plan (MDPP) guidelines). VA will provide the virtual guest instances and an associated operating system, and the vendor will provide all other software required for the MTS.

f. The MTS client used by the Mammography Technologists or NTP administrators should be a web-based application that does not require the installation of any end user applications or OS components and shall be compatible with the latest version of Microsoft Edge utilized by VA. If client software is required on the Tech workstations, it will be installed by VA personnel, but updates and upgrades must be accomplished without requiring elevated privileges on the client workstation. If a client application is required, it must be reviewed and approved by VA Technical Reference Model (TRM).

g. The system shall provide patient exam tracking, mammography technologist input/interface with site-specific reporting, and patient notification (recall/reminder letters) that are compliant with the Food and Drug Administration (FDA) Mammography Quality Standards Act (MQSA).

h. The system is compliant with FDA MQSA quality assurance reporting; that is, patient tracking, patient documentation, breast density notification, and medical outcomes audit as written in the FDA's amended MQSA regulations (effective September 10, 2024).

i. The system shall incorporate automated risk scoring to include Tyrer-Cuzick, American College of Radiology (ACR) compliant BI-RADS structured reporting (support for both MTS and PS/VR driven reporting).

j. The system can be configured to accept and track Veteran-based specific population risk factors. For example, the Supporting Expanded Review for

Veterans in Combat Environment (SERVICE) Act allows Veterans who served in certain combat locations and periods.

k. Bi-directional HL7 integration with NTP PACS and VR components.

l. HL7 integration for inbound ORM and ORU from each of the sites via NTP PACS, i.e., the NTP PACS will serve as the HL7 interface/broker for HL7 messages to VistA/CPRS and Oracle Health EHRs.

m. API to the NTP PACS and PACS workstations that provides for patient context exchange and synchronization between the NTP PACS components and the MTS.

n. NTP PACS incorporates an artificial Intelligence module for breast density, risk, and quality (Densitas AI bundle including intelliMammo). The MTS will provide an interface to incorporate this data.

o. The MTS automatically sends the patient lay summary in VistA/CPRS or Oracle Health electronic health records.

p. The proposed solution includes data migration of studies from the current mammography tracking system for all prior studies, if needed.

q. Development of an implementation plan that outlines objectives, tasks, and milestones required for the implementation.

(1) The vendor-hosted calls will highlight recently completed activities, next steps, risks requiring management attention, and milestones.

(2) The implementation team will conduct a workflow review and consult on a customer-specific workflow plan.

(3) The implementation team will also:

• Review the completed implementation survey.

• Perform the table build based on information delivered by the customer.

• Configure and customize the system based on customer preferences.

• Plan and conduct application unit testing.

• Plan and conduct integrated testing of the system.

• Conduct remote pre-training activities with designated super-users and key staff.

• Develop on-site training and go-live plan.

• Locate and review application logs.

• Install and configure required components.

r. Service/maintenance of VA NTP MTS: the system shall provide:

(1) 24/7 Customer Service Support.

(2) Software obsolescence, major upgrades, revisions, patches, and fixes for 12 months.

(3) A guaranteed minimum 99% uptime of the MTS.

1. Uptime is calculated based off the following

Uptime

CoverageofHours DownHoursCoverageofHours

− 100 o Hours of Coverage in the above equation exclude hours for preventive and scheduled maintenance of the system.

(4) Planned Maintenance shall be planned outside of normal business hours. Normal business hours are Monday–Friday 7:00am (ET) – 9:00pm (ET).

(5) Service/support shall include a one-hour response time for critical issues and the next business day for non-critical issues.

(6) Shall provide all application updates and upgrades for the term of the contract.

(7) Shall provide remote support via VA site-to-site VPN with accompanying VA-mandated annual information security and privacy training, along with background investigations. The Contractor shall agree to comply with all applicable VA security requirements and obtain/maintain VA credentials, or contractor support staff shall obtain VA PIC/CAC cards with elevated privileges and utilize VA’s Azure Virtual Desktop for remote access.

(8) Shall limit system access to only those individuals requiring access to perform functions related to NTP. The Contractor shall permit only authorized users at their site to have access to VA supporting systems and resources.

(9) Shall provide vulnerability remediation. Monthly vulnerability reports shall be provided by the VA to the Contractor. Remediations shall be completed according to the timelines outlined in the Department of Homeland Security, Cybersecurity, and Infrastructure Security Agency's Binding Operational Directive (BOD) 22-01 and its successors. For vulnerabilities not covered by BOD 22-01, the following deadlines will apply: Critical = 60 days, High = 90 days, Medium = 120 days, and Low = 150 days

(10) Shall provide all security maintenance and updates/upgrades required for ongoing compliance with NIST, FISMA, and VA security standards.

(11) Shall be responsible for all OS patching, Anti-Virus and security updates, and application updates/upgrades to meet VA security requirements/vulnerability remediation for all components of the system and shall comply with Department of Homeland Security, Cybersecurity, and Infrastructure Security Agency’s Binding Operational Directive (BOD) 22-01 and its successors. The VA will designate the criticality of the updates/upgrades, and the Contractor shall address in the timeline identified per VA policy.

(12) Windows OS patches are available via an internal Windows Server Update Services (WSUS) repository. Routine patching and application updates shall be completed within 15 days of release.

(13) Shall support ongoing workflow and integration changes as VA incrementally adds additional sites as requested.

4. Hours of Operation:

Normal business hours are Monday through Friday from 7:00 am (ET) – 9:00 pm (ET).

5. Competency of personnel: All work shall be performed by OEM-certified personnel.

All work performed shall be in accordance with commercial practices and the system manufacturer’s specifications.

6. Documentation: For all support incidents, the Contractor shall furnish a service report describing the malfunction and all work and materials required to correct the problem.

7. Acceptance of work: Completion of all work is subject to the approval of VA NTP. In addition, the documentation of the work is subject to approval by VA NTP.

8. Condition of equipment: The Contractor accepts responsibility for the system in "as is" condition. Failure to inspect the system prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

9. Payment: - Invoices will be paid in arrears on a monthly basis. Invoices MUST INCLUDE, at a minimum, the following information: Contract No., Purchase Order No., Item(s) covered, and covered period of service.

10. Optional Tasks:

a. These shall be included as optional tasks for the period of performance of the contract. When exercised the Contractor shall:

1. Deploy API to the NTP PACS and PACS workstations that provide for patient context exchange and synchronization between the NTP PACS components and the MTS.

2. Deploy any additional sites selected by VA NTP. These shall be added to the existing MTS and include all features available for what currently exists in the system (HL7 integration, API interface, etc).

3. When these are exercised, they should include project management and implementation services, including the following:

o Project plan for the customer's approval. The plan outlines objectives, tasks, and milestones required for implementation.

o The Project Manager will host weekly conference calls that will highlight recently completed activities, next steps, risks to the project requiring management attention, and milestones.

o The Project Manager will coordinate all of the implementation resources throughout the project.

o The Implementation team will conduct a workflow review and consult on a customer-specific workflow plan.

o The implementation team will also:

Review the completed implementation survey.

Perform the table build based on information delivered by the customer.

Configure and customize the system based on customer preferences.

Plan and conduct application unit testing.

Plan and conduct integrated testing of the system.

Conduct remote pre-training activities with designated super-users and key staff.

Develop on-site training and go-live plan.

4. When exercised, the contractor shall provide extraction/import of the site’s MTS data and import of data into the VA NTP database with testing and validation per database or for multiple databases added at a single time.

5. When exercised, the contractor shall provide on-site training for mammography staff at the identified locations in the SOW section 3b.

6. When exercised, the contractor shall provide a combination of on-site and remote Radiologist training.

Table 2 Optional Tasks

Period of Performance: Site deployment shall occur no later than 60 days after exercise of an optional task, plus a 12-month warranty on deployed sites

(Not to Exceed (NTE))

Quantity Description of Supplies

NTE 2 API interface for NTP PACS workstations

NTE 5

Initial implementation for new site activation to include HL7 interface connection and testing, procedural code gathering, staffing information, letter customization, site configuration, and remote training.

NTE 5

Optional Data extraction/import of current vendor MTS data and import of data into VA NTP database with testing and validation per database or for multiple databases added at a single time.

NTE 5 On-site training (minimum two-day visit).

NTE 2 Radiologist training (minimum two-day visit).

B. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the VA Contracting Officer (CO). A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

Schedule of Deliverables

Deliverable No. Item Quantity Delivery Date

1 Deployment, testing, activation and end user training of MTS

Base Year

2 Integration with Densitas intelliMammo 1 Base Year

3 Integration with PS1 1 Base Year

4 PACS workstation API 1 Base Year

5 Ongoing service/support to include system and client software updates and upgrades. Billed on a fee/study model for each parent mammography exam interpreted by NTP.

7,500

Base Year

2 Ongoing service/support to include system and client software updates and upgrades. Billed on a fee/study model for each parent mammography exam interpreted by NTP.

10,000

Option Year 1

3 Ongoing service/support to include system and client software updates and upgrades. Billed on a fee/study model for each parent mammography exam interpreted by NTP.

12,500

Option Year 2

4 API interface for NTP PACS workstations NTE 2

Optional Task:

Base – Option Year 2

5 Initial implementation fee for new site activation to include HL7 interface connection and testing, procedural code gathering, staffing information, letter customization, site configuration, and remote training.

NTE 5

Optional Task:

Base – Option Year 2

6 Optional Data extraction/import of current MRS/Patient Hub data and import of data into VA NTP database with testing and validation per database or for multiple databases added at a single time (maximum 4 combined databases).

NTE 5

Optional Task:

Base – Option Year 2

7 On-site training (minimum two-day visit). NTE 5

Optional Task:

Base – Option Year 2

8 Radiologist training (minimum two-day visit). NTE 2

Optional Task:

Base – Option Year 2

6500.6 Security Clauses

Appendix B

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.

Appendix C

1. 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.

1. VA INFORMATION CUSTODIAL LANGUAGE.

This entire section applies to all acquisitions requiring any Information Security and Privacy 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

k. 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.

l. 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.

m. 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.

n. 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.

o. 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 POC/CO, the contractor shall return all Federal Records to VA for disposition.

p. 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 VA Point of Contact (POC) 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 POC/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the POC/CO within 30 business days of termination of the contract.

q. 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.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to 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.

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 POC/CO in writing prior to access being granted.

e. The contractor shall notify the POC/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 POC/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA access 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 POC/CO.

3. TRAINING. This entire section applies to all acquisitions which include section 3.

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)) 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 POC/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.

4. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

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 POC/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.

5. INFORMATION SYSTEM DESIGN AND DEVELOPMENT. This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (to include the subcomponents of each) designed or developed for or on behalf of VA by any non-VA entity.

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 POC/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 the 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 https://www.va.gov/oal/library/vaar/vaar852.asp#85221176 https://www.va.gov/oal/library/vaar/vaar852.asp#85221176

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 POC 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 POC/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 POC/CO that the patch has been validated as to not affecting the Systems within 10 business days.

6. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE.

This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (cloud and non- cloud) hosted, operated, maintained, or used on behalf of VA at non-VA facilities.

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.