Draft Performance Work Statement - Image Guided Procedure Tool.docx

Image Guided Procedure Tool

VA-25-00075965

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

National Center for Collaborative Healthcare Innovation (NCCHI)

Image Guided Procedure Tool

Date: 8/25/2025

VA-25-00075965

PWS Version Number: 2.0

Contents

BACKGROUND

The Department of Veterans Affairs (VA), National Center for Collaborative Healthcare Innovation (NCCHI) strives to provide high quality, effective, and efficient Information Technology (IT) services to those responsible for providing care to the Veterans at the point-of-care as well as throughout all the points of the Veterans’ health care in an effective, timely and compassionate manner. In accordance with Executive Order 13960, which mandates the adoption of trustworthy artificial intelligence (AI) to enhance Government efficiency and effectiveness, this effort’s Performance Work Statement outlines our commitment to leveraging AI innovation. The order underscores the importance of acquiring AI capabilities that are both cost-effective and timely while remaining secure and reliable.

APPLICABLE DOCUMENTS

In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

1. “Federal Information Security Modernization Act of 2014”

2. Federal Information Processing Standards (FIPS) Publication 140-3, “Security Requirements for Cryptographic Modules”, March 22, 2019

3. FIPS Pub 199. “Standards for Security Categorization of Federal Information and Information Systems,” February 2004

4. FIPS Pub 200, “Minimum Security Requirements for Federal Information and Information Systems,” March 2006

5. FIPS Pub 201-3, “Personal Identity Verification of Federal Employees and Contractors,” January 2022

6. 10 U.S.C. § 2224, "Defense Information Assurance Program", as amended

7. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

8. Public Law 109-461 (P.L. 109-461), Veterans Benefits, Health Care, and Information Technology Act of 2006, as amended, Title IX, Information Security Matters

9. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”, as amended

10. VA Directive 0710, “Personnel Security and Suitability Program,” June 4, 2010, https://www.va.gov/vapubs/index.cfm

11. VA Handbook 0710, “Personnel Security and Suitability Program,” May 2, 2016, https://www.va.gov/vapubs/index.cfm

12. VA Directive 6102, “Internet/Intranet Services,” August 5, 2019

13. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” as amended

14. Office of Management and Budget (OMB) Circular A-130, “Managing Federal Information as a Strategic Resource,” July 28, 2016

15. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”, as amended

16. NIST SP 800-66 Rev. 2, “Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide,” February 2024

17. 45 C.F.R Parts 160 and 164, Subparts A and E, the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”); and 45 C.F.R. Parts 160 and 164, Subparts A and C, the Security Standard (“Security Rule”); as amended

18. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended

19. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004

20. VA Directive 6500, “VA Cybersecurity Program,” February 24, 2021 (see VA NOTICE 24-18, dated September 27, 2024, “Update to VA Directive 6500 Cybersecurity Program”, and VA Notice 25-07, dated 3/18/25, “Amending VA Directive 6500 to incorporate M-24-15”)

21. VA Handbook 6500, “Risk Management Framework for VA Information Systems VA Information Security Program,” February 24, 2021 (see VA Notice 25-01, dated October 15, 2024, “Update to VA Handbook 6500 Risk Management Framework for VA Information Systems VA Information Security Program”, and VA Notice 25-06, dated 3/18/25, “Amending VA Directive 6500 to incorporate M-24-15”)

22. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI),” June 30, 2023

23. VA Handbook 6500.6, “Contract Security,” March 12, 2010 (see VA Notice 24-12, dated April 22, 2024, “Update to VA Handbook 6500.6, Contract Security, Appendix C VA Information and Information System Security/Privacy Language For Inclusion Into Contracts, As Appropriate”)

24. VA Handbook 6500.8, “Information System Contingency Planning,” March 25, 2025

25. VA Handbook 6500.10, “Mobile Device Security Policy,” February 15, 2018

26. VA Handbook 6500.11, “VA Firewall Configuration,” August 22, 2017

27. OIT Process Asset Library (PAL), OIT Process Asset Library.

28. One-VA Technical Reference Model (TRM) (reference at https://www.va.gov/trm/TRMHomePage.aspx)

29. VA Directive 6508, “Implementation of Privacy Threshold Analysis and Privacy Impact Assessment,” October 15, 2014

30. VA Directive 6510, “VA Identity, Credential and Access Management,” September 3, 2024

31. VA Handbook 6510, “VA Identity, Credential and Access Management,” September 27, 2024

32. VA Directive and Handbook 6513, “Secure External Connections,” October 12, 2017

33. VA Directive 6300, “Records and Information Management,” September 21, 2018

34. VA Handbook, 6300.1, “Records Management Procedures,“ March 24, 2010

35. NIST SP 800-37 Rev 2, “Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy,” December 2018

36. NIST SP 800-53 Rev. 5, “Security and Privacy Controls for Federal Information Systems and Organizations,” September 23, 2020 (includes updates as of 12/10/2020)

37. VA Directive 0735, “Homeland Security Presidential Directive 12 (HSPD-12) Program,” October 26, 2015

38. VA Handbook 0735, “Homeland Security Presidential Directive 12 (HSPD-12) Program,” March 24, 2014

39. OMB Memorandum 05-24, “Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors,” August 5, 2005

40. OMB Memorandum M-19-17, “Enabling Mission Delivery Through Improved Identity, Credential, and Access Management,” May 21, 2019

41. OMB Memorandum, “Guidance for Homeland Security Presidential Directive (HSPD) 12 Implementation,” May 23, 2008

42. Federal Identity, Credential, and Access Management (FICAM) Architecture, June 30, 2023 (FICAM Architecture (idmanagement.gov))

43. NIST SP 800-116 Rev 1, “Guidelines for the Use of Personal Identity Verification (PIV) Credentials in Facility Access,“ June 2018

44. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, “Digital Identity Guidelines,” updated March 02, 2020

45. NIST SP 800-157, “Guidelines for Derived PIV Credentials,” December 2014

46. VA Memorandum, VAIQ #7100147, “Continued Implementation of Homeland Security Presidential Directive 12 (HSPD-12),” April 29, 2011 (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

47. IAM Identity Management Business Requirements Guidance document, May 2013, (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

48. VA Memorandum “Personal Identity Verification (PIV) Logical Access Policy Clarification,” July 17, 2019, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896

49. Trusted Internet Connections (TIC) 3.0 Core Guidance Documents, https://www.cisa.gov/publication/tic-30-core-guidance-documents

50. OMB Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative,” September 12, 2019

51. OMB Memorandum M-08-23, “Securing the Federal Government’s Domain Name System Infrastructure,” August 22, 2008

52. Executive Order 13221, “Energy-Efficient Standby Power Devices,” August 2, 2001

53. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote Access,” January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

54. Clinger-Cohen Act of 1996, 40 U.S.C. §11101 and §11103

55. “Veteran Focused Integration Process (VIP) Guide 4.0,” March 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

56. VA Memorandum “Proper Use of Email and Other Messaging Services,” January 2, 2018, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

57. “Product Line Management Transformation Playbook” version 3.1, August 2023, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946

58. NIST SP 500-267B Revision 1, “USGv6 Profile,” November 2020

59. OMB Memorandum M-21-07, “Completing the Transition to Internet Protocol Version 6 (IPv6),” November 19, 2020

60. Social Security Number (SSN) Fraud Prevention Act of 2017

61. Section 240 of the Consolidated Appropriations Act (CAA) 2018, March 23, 2018

62. C.F.R Title 15 Part 7, “Securing the Information and Communications Technology and Services (ICTS) Supply Chain”, as amended

63. Executive Order 14028, “Executive Order on Improving the Nation's Cybersecurity,” May 12, 2021, https://bidenwhitehouse.archives.gov/briefing-room/presidential-actions/2025/01/16/executive-order-on-strengthening-and-promoting-innovation-in-the-nations-cybersecurity/

64. OMB Memorandum M-22-09, “Moving the U.S. Government Toward Zero Trust Cybersecurity Principles”, January 26, 2022, https://www.whitehouse.gov/wp-content/uploads/2022/01/M-22-09.pdf.

65. NIST SP 800-52 Revision 2, “Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) Implementations

66. OMB M-22-18, “Enhancing the Security of the Software Supply Chain through Secure Software Development Practices,” September 14, 2022

67. OMB M-23-16, “Update to Memorandum M-22-18,” June 9, 2023

68. OMB M-21-31, “Improving the Federal Government’s Investigative and Remediation Capabilities Related to Cybersecurity Incidents,” August 27, 2021

69. NIST SP 800-88 Revision 1 “Guidelines for Media Sanitization,” December 2014

70. CISA Binding Operational Directive (BOD) 19-02: “Vulnerability Remediation Requirements of Internet-Accessible Systems,” April 29, 2019, BOD 19-02: Vulnerability Remediation Requirements for Internet-Accessible Systems | CISA

71. CISA BOD 22-01: “Reducing the Significant Risk of Known Exploited Vulnerabilities,” November 3, 2021, BOD 22-01: Reducing the Significant Risk of Known Exploited Vulnerabilities | CISA

72. CISA BOD 23-01: Improving Asset Visibility and Vulnerability Detection on Federal Networks.” Cybersecurity & Infrastructure Security Agency (CISA), BOD 23-01: Improving Asset Visibility and Vulnerability Detection on Federal Networks | CISA

73. VA Directive 6550, Pre-Procurement Assessment and Implementation of Medical Devices/Systems, June 03, 2019

74. VA Memorandum, “VA Security Controls,” January 17, 2025, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010

SCOPE OF WORK

The Contractor shall implement a cutting-edge clinical collaboration and education tool for image-guided proceduralists. The solution shall have the capability to provide real-time, low-latency surgical navigation, case collaboration with shared visualization and annotation experiences amongst different users, and shall be capable of incorporating a variety of hardware including augmented reality headsets, tablets, desktop/laptop computers, and/or smartphones in a Health Insurance Portability and Accountability Act (HIPAA) compliant manner.

For surgical navigation, the objective is to facilitate complex anatomic orientation of image-guided proceduralists. The solution shall be capable of low-latency and accurate segmentation/reformatting of two dimensional images such as Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) into three dimensional (3D) reconstructions as well as the ability for instrument tracking on live or archived images for educational, and, eventually, clinical purposes. Additionally, the solution shall allow for visualization of live images to improve the ergonomics of image-guided proceduralists.

For clinical collaboration, the objective is to provide a HIPAA compliant solution that allows multiple users to view archived or live-intraprocedural images and provide audio/video input and annotation capabilities in a shared viewing experience in real time with low latency. Additionally, the collaboration environment shall be available to users in AR headsets (e.g. VisionPro), smartphone/tablet, or laptop/desktop computers to allow access from a variety of potential users.

To evaluate the success of implementation, subjective user feedback will be obtained for both tasks, starting in the educational environment for Gastrointestinal (GI) endoscopy and interventional radiology. Spatial accuracy, ergonomics, and radiation exposure (where relevant) will also be collected. The solution shall be successfully deployed on an internal cloud environment provisioned for this pilot, and HIPAA compliance confirmed prior to use in the clinical environment. AR headsets will be provided by the vendor including any technical support both on site and remotely. Technical requirements for implementing the solution will be provided by VHA, as well as archived imaging and device data from image-guided procedures relevant to the initial use cases will be provided to the Contractor to ensure compatibility and customization to the use cases of interest.

The deployment must ensure that the solution is seamlessly integrated into the existing infrastructure, offering reliable performance and user-friendly interfaces to facilitate its adoption by educators and trainees and to create an interactive and effective learning environment that supports the development of critical decision-making skills and deeper understanding through advanced simulation and visualization. In addition to the subjective improvements in educational and clinical workload for practitioners, it is expected that accomplishing both of these objectives will help to raise the standard of procedural care across VHA through the ability to collaborate and educate amongst practitioners of varying skillsets and capabilities in performing image-guided procedures.

PERFORMANCE DETAILS

PERFORMANCE PERIOD

The PoP shall be 12-months from date of award.

Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

There are 11 Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, five are set by date:

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

PLACE OF PERFORMANCE

Tasks under this PWS shall be performed primarily at the Contractor facility and occasionally at a Government facility as necessary. Performance will be monitored by the Contracting Officer’s Representative (COR) at a government location. Any work at the Government site shall not take place on Federal holidays or weekends unless authorized and/or directed by the Contracting Officer (CO). Federal holidays are set by law (USC Title 5 Section 6103). The Contractor shall observe the Federal holidays observed during the period of performance. Observation of Federal holidays can be found at www.opm.gov, and the contract shall observe the Federal holidays as indicated for each year the contract is in place.

TRAVEL

There is no anticipated travel associated with this requirement.

SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform and provide an audio/visual agent client application that supports cinematic volumetric rendering of 3D imaging, textured geometric 3D models, audiovisual remote collaboration, and message-based synchronization. Confirm compatibility with smartphone, tablet, and desktop applications in HIPAA compliant manner.

Contractor shall meet VA IT requirements including deployment of the solution on the provisioned internal cloud environment (e.g. Azure), and integration with Picture Archiving and Communication System PACS at pilot site. Port numbers will be assigned by VHA as needed for integration in the clinical environment for live streaming. The solution shall provide Image processing including rapid segmentation, registration, and 2D to 3D rendering of a retrospective (archived) set of 20 cases of advanced GI endoscopy (e.g. ERCP) and 20 retrospective (archived) angiography cases from Interventional Radiology. Images will include historical Digital Imaging and Communications in Medicine DICOM MRI, CT, and fluoroscopic images archived from previously performed procedures, and will be provided by VHA to the Contractor for the purposes of confirming compatibility with VA imaging systems as well as functionality. User feedback shall be obtained.

The solution shall provide Low-latency real-time image processing as detailed in task 5.2 with real time surgical navigation (e.g. instrument tracking) of a prospective set of 10 live cases for GI endoscopy (ERCP, advanced endoscopy) and 10 live cases for angiography in Interventional Radiology using the following devices: AR headset, and at least one of the following: smartphone, tablet, laptop/desktop for each case for real-time education in the procedural environment. Software will be HIPAA compliant with low-latency performance of the tasks listed. User feedback for operators using headsets and trainees on other device will be obtained.

PROJECT REPORTING REQUIREMENTS

The Contractor shall provide the COR with Monthly Progress Report in electronic form in Microsoft Word and Project formats. The report shall include detailed instructions/explanations for each required data element, to ensure that data is accurate and consistent. The report shall reflect data as of the last day of the preceding Month.

The Monthly Progress Report shall cover all work completed during the reporting period and work planned for the subsequent reporting period. The report shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation including their plan and timeframe for resolving the issue. The report shall also include an itemized list of all Information and Communication Technology (ICT) deliverables and their current Section 508 conformance status. It is expected that the Contractor will keep in communication with VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.

Deliverable:

A. Monthly Progress Report Deployment, and Surgical Navigation and Image Processing The Contractor shall provide AR headsets and client application, along with required hardware for real-time image processing. The Contractor shall provide a HIPAA compliant software solution to perform low-latency segmentation, registration, and 3D rendering of MRI, CT, and/or fluoroscopic images of archived DICOM images or point of care DICOM images. Additionally, the HIPAA compliant software solution shall have the capability for shared audiovisual communication, shared viewing, case collaboration, and annotation from simultaneous viewers, compatible with AR headset, tablet, smartphone, and laptop/desktop application.

A. Solution capable of loading DICOM and Graphics Image Processing Library GIPL files into a shared viewing session from a web-based or on-device DICOM server with distribution, synchronized viewing, and synchronized annotation available to participants in a session.

B. Demonstrate additional functionality as described: ability to convert 2D to 3D images, provide annotation and archiving capabilities, instrument tracking, registration and segmentation of images using both pre-procedural and intraprocedural data (real-time), and procedural navigation capabilities. Streaming data should be able to inform and update models created by the device, including registration with 3D imaging and instrument tracking.

C. The system is compatible with multiple device types—including mixed-reality headsets, web browsers, and tablets—and can operate in a HIPAA-compliant manner across all supported platforms. Demonstrate the following functions in the simulation and procedural environment: segmentation (extracting regions of interest from source imaging such as CT or MRI as part of a procedure preparation process), image-registration (co-registering images acquired from different modalities such as CT/MRI and fluoroscopy), and low-latency instrument tracking (guidewire tracking or endoscopic device tracking that can be mapped on to real-time or pre-procedural data).

D. Demonstrate generation of an intraoperative 3D imaging model that is able to perform live-instrument tracking and real-time consultation, ideally in either the gastrointestinal endoscopy and/or angiography clinical arenas for educational or simulation purposes.

E. Image-preparation pipeline F. Fluoroscopic mono-planar image capture in real-time G. Fluoroscopic image registration using fiducial markers H. Demonstrate functionality in retrospective procedural environment I. Demonstrate functionality in prospective (or live-streamed) procedural environment Clinical collaboration and shared viewing Deployment of on-premises education decision support tool for simulation and visualization shall include the following:

A. Audio/Visual communication between multiple users for HIPAA compliant case review using real time/live streaming of DICOM images in simulation or intraprocedural environments.

B. Annotation tools to include region of interest, measurement tools that are synchronized amongst participants in real time in a device agnostic manner (tablet, smartphone, desktop, etc).

C. HIPAA compliant Browser-based direct connection for enhanced visualization of images and collaboration/education for operator and team.

D. Demonstrate use case in GI endoscopy (ERCP) and Interventional Radiology angiography procedural environments. Demonstrate successful use for education/simulation (retrospective) as well as real-time proctoring or shared case viewing (prospective) in a HIPAA compliant manner.

GENERAL REQUIREMENTS

ENTERPRISE AND IT FRAMEWORK

VA TECHNICAL REFERENCE MODEL

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

ZERO TRUST – VA CRITICAL SECURITY CONTROLS

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

FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)

The Contractor shall ensure Commercial Off-The-Shelf (COTS) product(s), software configuration and customization, and/or new software are Personal Identity Verification (PIV) card-enabled by accepting HSPD-12 PIV credentials using VA Enterprise Architecture (EA), and VA Identity and Access Management (IAM) approved Enterprise Technology Guidelines (ETG). The Contractor shall ensure all Contractor delivered applications and systems comply with the VA Identity, Credential, and Access Management policies and guidelines set forth in Executive Order 14028, VA Handbook 6510 VA Identity and Access Management, VA Handbook 0735 Homeland Security Presidential Directive 12 (HSPD-12) Program, CISA Binding Operational Directive 23-01, and align with the Federal Identity, Credential, and Access Management Roadmap and Implementation Guidance v2.0.

The Contractor shall ensure all Contractor delivered applications and systems provide user authentication services compliant with the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-63-3, VA Handbook 6500, and VA IAM enterprise requirements for direct, assertion based authentication, and/or trust based authentication, as determined by the ETGs. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV card and/or Common Access Card (CAC), as determined by the business need.

The Contractor shall ensure all Contractor delivered applications and systems conform to the specific Identity and Access Management PIV requirements set forth in the Office of Management and Budget (OMB) Memoranda M-05-24, M-19-17, M-22-09, and NIST Federal Information Processing Standard (FIPS) 201-3. Contractor delivered applications and systems shall be on the FIPS 201 Approved Product List (APL). If the Contractor delivered application and system is not on the APL, the Contractor shall be responsible for taking the application and system through the FIPS 201 Evaluation Program.

The Contractor shall ensure all Contractor delivered applications and systems support:

1. Automated provisioning and are able to use enterprise provisioning service.

2. Interfacing with VA’s Master Person Index (MPI) to provision identity attributes, if the solution relies on VA user identities. MPI is the authoritative source for VA user identity data.

3. The VA defined unique identity (Secure Identifier [SEC ID] / Integrated Control Number [ICN]).

4. Multiple authenticators for a given identity and authenticators at every Authenticator Assurance Level (AAL) appropriate for the solution.

5. Identity proofing for each Identity Assurance Level (IAL) appropriate for the solution.

6. Federation for each Federation Assurance Level (FAL) appropriate for the solution, if applicable.

7. Two-factor authentication (2FA) through an applicable Technology Guideline as outlined in VA ETG.

8. A Security Assertion Markup Language (SAML) implementation if the solution relies on assertion-based authentication. Additional assertion implementations, besides the required SAML assertion, may be provided as long as they are compliant with NIST SP 800-63-3 guidelines.

9. Authentication/account binding based on trusted Hypertext Transfer Protocol (HTTP) headers if the solution relies on Trust based authentication.

10. Role Based Access Control.

11. Auditing and reporting capabilities.

12. Compliance with VIEWS 00155984, PIV Logical Access Policy Clarification https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896.

The required Assurance Levels for this specific effort are Identity Assurance Level 3, Authenticator Assurance Level 3, and Federation Assurance Level 3.

INTERNET PROTOCOL VERSION 6 (IPv6) The Contractor solution shall support IPv6-Only based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). Which defines IPv6-only as the state of an operational system or service when IPv4 protocol functions (addressing, packet forwarding) are not in use. The NIST USGv6 profile defines technical requirements for a product to be capable of operating in IPv6-Only environments. IPv6-Only technology, in accordance with the USGv6 Program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices, applications, and systems shall support all applicable functionality on native IPv6-Only as well as dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g., web, email, DNS, ISP services, etc.) shall support native IPv6-Only and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall support using native IPv6-Only and dual stack (IPv6 / IPv4) for all functionality and operations.

TRUSTED INTERNET CONNECTION (TIC)

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

STANDARD COMPUTER CONFIGURATION

The Contractor IT end user solution that is developed for use on standard VA computers shall be compatible with and be supported on the standard VA operating system, Windows 10 (64bit) and Windows 11, Edge (Chromium based), and 365 Apps for enterprise. Applications delivered to VA and intended to be deployed to Windows 10 and or Windows 11 workstations shall be delivered as a signed .msi package with switches for silent and unattended installation and updates shall be delivered in signed .msp file formats for easy deployment using Microsoft Endpoint Configuration Manager (CM) VA’s current desktop application deployment tool. Signing of the software code shall be through a vendor provided certificate that is trusted by VA using a code signing authority such as Verizon/Cybertrust or Symantec/VeriSign. The Contractor shall also ensure and certify that their solution functions as expected when used from a standard VA computer, with non-admin, standard user rights that have been configured using the Defense Information Systems Agency (DISA) Secure Technical Implementation Guide (STIG) specific to the particular client operating system being used.

VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT LINE MANAGEMENT (PLM)

The Contractor shall support VA efforts IAW the Veteran-Focused Integration Process (VIP) Guide and Product Line Management (PLM) Playbook. The major focus of VIP is on Enterprise Oversight, Governance, reporting, and establishing practices that focus on outcomes and continuously delivering sustainable IT capabilities to benefit the Veteran. PLM is a framework that focuses on delivering functional products that provide the highest priority work to customers while delivering simplified, reliable, and practical solutions to the business, medical staff, and our Veterans. The VIP Guide is a companion guide to the PLM Transformation Playbook and can be found at: https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 and the PLM Transformation Playbook can be found at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946. VIP and PLM are the authoritative processes that IT projects must follow to ensure development and delivery of IT products.

The VIP Guide provides guidance for transitioning from project-centric to product-centric delivery. The VIP guide applies to all OIT Office of Management and Budget (OMB) reportable products that are required to collect and report costs, schedules, risks, and other valuable information in VA PARS (whether products are procured or developed by VA) and any VA Information Technology project effort in Software Product Management (SPM) and Infrastructure Operations (IO), or their successors, that touch the VA network regardless of IT organizational alignment (whether it spends government funding from VA's Congressional IT Appropriation or any other appropriation).

The PLM Transformation Playbook details how OIT leadership expects Product Lines (PLs) to implement PLM, DevOps, and Lean-Agile principles, methods, practices, and techniques through levels of maturity. The PLM Transformation Playbook applies to all Information Technology (IT) products aligned to PLs in the Software Product Management, Infrastructure Operations and Product Engineering organizations within the OIT organization.

Others outside the referenced groups or organizations may use the VIP Guide and PLM Transformation Playbook for situational awareness as needed.

PROCESS ASSET LIBRARY (PAL)

The Contractor shall perform their duties consistent with the processes defined in the OIT Process Asset Library (PAL). The PAL includes a spectrum of OIT functions and activities, such as project management, operations, service delivery, communications, acquisition, and resource management. PAL serves as an authoritative and informative repository of searchable processes, activities or tasks, roles, artifacts, tools and applicable standards and guides to assist the OIT workforce, Government and Contractor personnel. OIT utilizes PAL processes to ensure compliance with policies and regulations and to meet VA quality standards. The PAL includes the contractor onboarding process consistent with Section 6.2.2 and can be found at process_CONB_ext.docx (live.com). The main PAL can be accessed at www.va.gov/process.

AUTHORITATIVE DATA SOURCES

The VA Enterprise Architecture Repository (VEAR) is one component within the overall EA that establishes the common framework for data taxonomy for describing the data architecture used to develop, operate, and maintain enterprise applications. The Contractor shall comply with the department’s Authoritative Data Source (ADS) requirement that VA systems, services, and processes throughout the enterprise shall access VA data solely through official VA ADSs where applicable, see below. The Information Classes which compose each ADS are located in the VEAR, in the Data & Information domain. The Contractor shall ensure that all delivered applications and system solutions support:

1. Interfacing with VA’s Master Person Index (MPI) (formerly the Master Veteran Index (MVI)) to provision identity attributes, if the solution relies on VA user identities. MPI is the authoritative source for VA user identity data.

2. Interfacing with Capital Asset Inventory (CAI) to conduct real property record management actions, if the solution relies on real property records data. CAI is the authoritative source for VA real property record management data.

3. Interfacing with electronic Contract Management System (eCMS) for access to contract, contract line item, purchase requisition, offering vendor, and solicitation information above the micro-purchase threshold, if the solution relies on procurement data. ECMS is the authoritative source for VA procurement actions data.

4. Interfacing with HRSmart Human Resources Information System to conduct personnel action processing, on-boarding, benefits management, and compensation management, if the solution relies on personnel data. HRSmart is the authoritative source for VA personnel information data.

5. Interfacing with VA Profile to access personal contact information, if the solution relies on VA Veteran personal contact information data. VA Profile is the authoritative source for VA Veteran Personal Contact Data.

6. Interfacing with VA/Department of Defense (DoD) Identity Repository (VADIR) for determining eligibility for VA benefits under Title 38, if the solution relies on qualifying active duty military service data. VADIR is the authoritative source for qualifying active duty military service in VA.

7. Interfacing with VA Systems Inventory (VASI) to access VA systems information, if the solution relies on VA system information. VASI is the authoritative source for VA Information Technology systems.

8. Interfacing with Enterprise Mission Assurance Support Service (eMASS) to access the Authority to Operate (ATO) status of all VA Information Systems. eMASS contains the official Authority to Operate (ATO) status of all VA Information Systems.

SOCIAL SECURITY NUMBER (SSN) REDUCTION

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

SOFTWARE AND LICENSING REQUIREMENTS

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

SECURITY AND PRIVACY REQUIREMENTS

It has been determined that protected health information may be disclosed or accessed and a signed Business Associate Agreement (BAA) shall be required. The Contractor shall adhere to the requirements set forth within the BAA, referenced in Section D of the contract, and shall comply with VA Directive 6066.

POSITION/TASK RISK DESIGNATION LEVEL(S)

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

Position Sensitivity and Background Investigation Requirements by Task

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

METHOD AND DISTRIBUTION OF DELIVERABLES

The Contractor shall deliver documentation in electronic format, unless otherwise directed in Section B of the solicitation/contract. Acceptable electronic media include: Microsoft 365 suite, MS Word, MS Excel, MS PowerPoint, MS Project, MS Access, MS Visio, AutoCAD, and Adobe Postscript Data Format (PDF).

PERFORMANCE METRICS

2. Efficient and effective in meeting requirements

3. Meets technical needs and mission requirements

4. Provides quality services/products

5. Incorporates “ease of use” Human Centered Design principles in any software developed.

Satisfactory or higher

2. Products completed, reviewed, delivered in accordance with the established schedule

3. Notifies customer in advance of potential problems Satisfactory or higher

2. Personnel possess necessary knowledge, skills, and abilities to perform tasks Satisfactory or higher

The COR will utilize a Quality Assurance Surveillance Plan (QASP) throughout the life of the contract to ensure that the Contractor is performing the services required by this PWS in an acceptable level of performance. The Government reserves the right to alter or change the surveillance methods in the QASP at its own discretion.

ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED

Cyber and Information Security Requirements for VA IT Services The Contractor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard PWS language, conditions, laws, and regulations. The Contractor’s firewall and web server shall meet or exceed VA minimum requirements for security. All VA data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Program Manager and VA Information Security Officer as soon as possible. The Contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to assessment and authorization and continuous monitoring.

Contractor supplied equipment, PCs of all types, equipment with hard drives, etc. for contract services must meet all security requirements that apply to Government Furnished Equipment (GFE) and Government Owned Equipment (GOE). Security Requirements include: a) VA Approved Encryption Software must be installed on all laptops or mobile devices before being placed into operation, b) Bluetooth equipped devices are prohibited within VA; Bluetooth must be permanently disabled or removed from the device, unless the connection uses FIPS 140-2 (or its successor) validated encryption, c) VA approved anti-virus and firewall software, d) Equipment must meet all VA sanitization requirements and procedures before disposal. 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.

Each documented initiative under this contract incorporates VA Handbook 6500.6, “Contract Security,” March 12, 2010 (Appendix C updated April 22, 2024) by reference as though fully set forth therein. The VA Handbook 6500.6, “Contract Security” shall also be included in every related agreement, contract, or order. The VA Handbook 6500.6, Appendix C, is included in this document as Addendum B.

Training requirements: The Contractor shall complete all mandatory training courses on the current VA training site, the VA Talent Management System (TMS) 2.0, and will be tracked therein. The TMS 2.0 may be accessed at https://www.tms.va.gov/SecureAuth35/. If you do not have a TMS 2.0 profile, go to https://www.tms.va.gov/SecureAuth35/ and click on the “Create New User” link on the TMS 2.0 to gain access.

Contractor employees shall complete a VA Systems Access Agreement if they are provided access privileges as an authorized user of the computer system of VA.

VA Enterprise Architecture Compliance The applications, supplies, and services furnished under this contract must comply with VA Enterprise Architecture (EA), available at http://www.ea.oit.va.gov/index.asp in force at the time of issuance of this contract, including the Program Management Plan and VA's rules, standards, and guidelines in the Technical Reference Model/Standards Profile (TRMSP). VA reserves the right to assess contract deliverables for EA compliance prior to acceptance.

VA Internet and Intranet Standards

The Contractor shall adhere to and comply with VA Directive 6102 and VA’s Web Governance if the Contractor’s work includes building and maintaining VA’s digital presence. This pertains, but is not limited to: websites, social media, creating announcements; collecting information; databases to be accessed, graphics and links to external sites.

Internet/Intranet Services Directive 6102 is posted at (copy and paste the following URL to browser): https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1056&FType=2

VA Web Governance website can be found at Home - VA Web Governance.

Notice of the Federal Accessibility Law Affecting All Information and Communication Technology (ICT) Procurements (Section 508)

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

Section 508 – Information and Communication Technology (ICT) Standards

The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT. These standards are found in their entirety at: Revised 508 Standards and 255 Guidelines (access-board.gov). A single PDF file version of the Revised Section 508 Standards and 255 Guidelines will be supplied upon request, or can be obtained from the Access Board website. Federal agencies must comply with the Rehabilitation Act of 1973, as amended.

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

Compatibility with Assistive Technology

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

Acceptance and Acceptance Testing

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

The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon delivery.

Physical Security & Safety Requirements:

The Contractor and their personnel shall follow all VA policies, standard operating procedures, applicable laws and regulations while on VA property. Violations of VA regulations and policies may result in citation and disciplinary measures for persons violating the law.

1. The Contractor and their personnel shall wear visible identification at all times while they are on the premises.

2. VA does not provide parking spaces at the work site; the Contractor must obtain parking at the work site if needed.