DRAFT

PERFORMANCE WORK STATEMENT

DEPARTMENT OF VETERANS AFFAIRS

Electronic Health Record Modernization Integration Office

Blood Bank Validation Services

Date: May 19, 2026

VA-25-00023242

PWS Version Number: 1.2

TAC Number: VA-26-00023242

Contents

1.0 BACKGROUND

2.0 APPLICABLE DOCUMENTS

3.0 SCOPE OF WORK

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE PERIOD

4.2 PLACE OF PERFORMANCE

4.3 TRAVEL

5.0 SPECIFIC TASKS AND DELIVERABLES

5.1 PROJECT MANAGEMENT

5.1.1 CONTRACTOR PROJECT MANAGEMENT PLAN

5.1.2 REPORTING REQUIREMENTS

5.2 BLOOD BANK VALIDATION

5.2.1 ENTERPRISE BLOOD BANK VALIDATION PLAN

5.3 BLOOD BANK VALIDATION EXECUTION

5.4 SITE BLOOD BANK VALIDATIONS (Optional Task 1)

5.4.1 IDAHO, OREGON, WASHINGTON BLOOD BANK VALIDATIONS

(OPTIONAL TASK 1.1)

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

6.1.2 FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT

(FICAM) 12

6.1.3 INTERNET PROTOCOL VERSION 6 (IPV6)

6.1.4 TRUSTED INTERNET CONNECTION (TIC)

6.1.5 STANDARD COMPUTER CONFIGURATION

6.1.6 VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT

LINE MANAGEMENT (PLM)

6.1.7 PROCESS ASSET LIBRARY (PAL)

6.1.8 AUTHORITATIVE DATA SOURCES

6.1.9 SOCIAL SECURITY NUMBER (SSN) REDUCTION

6.1.10 SOFTWARE AND LICENSING REQUIREMENTS

6.2 SECURITY AND PRIVACY REQUIREMENTS

6.2.1 POSITION/TASK RISK DESIGNATION LEVEL(S)

6.2.2 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

6.3 METHOD AND DISTRIBUTION OF DELIVERABLES

6.4 PERFORMANCE METRICS

6.5 FACILITY/RESOURCE PROVISIONS

6.6 GOVERNMENT FURNISHED PROPERTY

6.7 SHIPMENT OF HARDWARE OR EQUIPMENT

ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED

ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM

SECURITY/PRIVACY LANGUAGE

1.0 BACKGROUND

The mission of the Department of Veterans Affairs (VA) Electronic Health Record Modernization Integration Office (EHRM-IO) is to transform how the VA delivers health care by implementing an enterprise-wide electronic health record (EHR) to standardize care across facilities, strengthen interoperability and collaboration with federal and community partners, foster innovation, improve provider and Veteran experiences, and ensure the continued delivery of high-quality, safe, and efficient health care to our nation’s Veterans. EHRM-IO is in the process of migrating VA’s 170 Medical Centers (VAMCs) from the Veterans Information Systems and Technology Architecture (VistA) to the Oracle Health (OH) Millenium EHR.

Many of these VAMCs operate a blood bank and/or perform transfusion services and will be using the Oracle Health Pathnet Blood Bank system after go-live.

Validation Services are required by regulatory and accreditation organizations (VA, Food and Drug Administration (FDA), Association of Advancement of Blood and Biotherapies (AABB), Clinical Laboratory Improvement Amendments (CLIA) and The Joint Commission (TJC)) to ensure patient and blood products safety. Compliance with the Food and Drug Administration (FDA) Regulations requires that these environments are validated prior to go-live.

The VA schedule for go-lives has 24 go-live events between September 2027 and November 2031. Each go-live event has between two (2) and 14 sites which will require validation to be completed simultaneously. There are 109 blood bank sites which require validation prior to go-live.

EHRM-IO seeks a contractor to provide blood bank validation services at each site with Full Blood Bank/Transfusion Medicine Services and those with transfusion only services to validate the build and configuration of the system, both for the local site build and enterprise review of all orderables, interpretation patterns, blood products, instrumentation connectivity and patient product compatibility.

Development of the contractor management plan shall begin at award. Site validation services are expected to start no later than four months prior to site go-live, last up to 12 weeks per site and be completed no later than one month prior to the Go-Live deployment date.

The North American Industry Classification System (NAICS) Code is 541519 “Other Computer Related Services”; the Product Service Code (PSC) IS Q301 “Reference – Laboratory Testing Services”.

2.0 APPLICABLE DOCUMENTS

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

1. 44 U.S.C. § 3541-3549, “Federal Information Security Management Act (FISMA) of 2002”

2. “Federal Information Security Modernization Act of 2014”

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

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

5. FIPS Pub 200, Minimum Security Requirements for Federal Information and

Information Systems, March 2016

6. FIPS Pub 201-2, “Personal Identity Verification of Federal Employees and

Contractors,” August 2013

7. 10 U.S.C. § 2224, "Defense Information Assurance Program"

8. Carnegie Mellon Software Engineering Institute, Capability Maturity Model®

Integration for Development (CMMI-DEV), Version 1.3 November 2010; and Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Acquisition (CMMI-ACQ), Version 1.3 November 2010

9. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

10. Public Law 109-461, Veterans Benefits, Health Care, and Information

Technology Act of 2006, Title IX, Information Security Matters

11. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

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

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

14. VA Directive and Handbook 6102, “Internet/Intranet Services,” August 5,

15. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” January 18, 2017

16. Office of Management and Budget (OMB) Circular A-130, “Managing Federal

Information as a Strategic Resource,” July 28, 2016

17. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed

Services (CHAMPUS)”

18. NIST SP 800-66 Rev. 1, An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008

19. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended, January 18, 2017

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

21. VA Directive 6500, “VA Cybersecurity Program,” January 24, 2019

22. VA Handbook 6500, “Risk Management Framework for VA Information

Systems – Tier 3: VA Information Security Program,” March 10, 2015 https://www.va.gov/vapubs/index.cfm https://www.va.gov/vapubs/index.cfm http://www.va.gov/vapubs http://www.va.gov/vapubs

23. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI)”, July 28, 2016

24. VA Handbook 6500.3, “Assessment, Authorization, And Continuous Monitoring of VA Information Systems,” February 3, 2014

25. VA Handbook 6500.5, “Incorporating Security and Privacy into the System Development Lifecycle”, March 22, 2010

26. VA Handbook 6500.6, “Contract Security,” March 12, 2010

27. VA Handbook 6500.8, “Information System Contingency Planning”, April 6,

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

29. OI&T Process Asset Library (PAL), https://www.va.gov/process/ . Reference

Process Maps at https://www.va.gov/process/maps.asp and Artifact templates at https://www.va.gov/process/artifacts.asp

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

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

32. VA Handbook 6508.1, “Procedures for Privacy Threshold Analysis and Privacy Impact Assessment,” July 30, 2015

33. VA Handbook 6510, “VA Identity and Access Management”, January 15,

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

35. VA Directive 6300, Records and Information Management, September 21,

36. VA Handbook, 6300.1, Records Management Procedures, March 24, 2010

37. NIST SP 800-37 Rev 1, Risk Management Framework for Information

Systems and Organizations: A System Life Cycle Approach for Security and Privacy, December 2018

38. NIST SP 800-53 Rev. 4, Security and Privacy Controls for Federal Information Systems and Organizations, January 22, 2015

39. OMB Memorandum, “Transition to IPv6”, September 28, 2010

40. VA Directive 0735, Homeland Security Presidential Directive 12 (HSPD-12)

Program, October 26, 2015

41. VA Handbook 0735, Homeland Security Presidential Directive 12 (HSPD-12)

Program, March 24, 2014

42. OMB Memorandum M-06-18, Acquisition of Products and Services for

Implementation of HSPD-12, June 30, 2006

43. OMB Memorandum 04-04, E-Authentication Guidance for Federal Agencies, December 16, 2003

44. 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

45. OMB memorandum M-11-11, “Continued Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common https://www.va.gov/process/ https://www.va.gov/process/maps.asp https://www.va.gov/process/artifacts.asp https://www.va.gov/trm/TRMHomePage.aspx

Identification Standard for Federal Employees and Contractors, February 3,

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

47. Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance, December 2, 2011

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

49. OMB Memorandum M-07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information, May 22, 2007

50. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, Digital Identity Guidelines, December 2017

51. NIST SP 800-157, Guidelines for Derived PIV Credentials, December 2014

52. NIST SP 800-164, Guidelines on Hardware-Rooted Security in Mobile

Devices (Draft), October 2012

53. Draft National Institute of Standards and Technology Interagency Report

(NISTIR) 7981 Mobile, PIV, and Authentication, March 2014

54. 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)

55. 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)

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

57. Trusted Internet Connections (TIC) Reference Architecture Document, Version 2.2, Federal Interagency Technical Reference Architectures, Department of Homeland Security, June 19, 2017, https://www.dhs.gov/sites/default/files/publications/TIC_Ref_Arch_v2.2_2017 .pdf

58. OMB Memorandum M-08-05, “Implementation of Trusted Internet Connections (TIC), November 20, 2007

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

60. VA Memorandum, VAIQ #7497987, Compliance – Electronic Product Environmental Assessment Tool (EPEAT) – IT Electronic Equipment, August 11, 2014 (reference Document Libraries, EPEAT/Green Purchasing Section, https://www.voa.va.gov/documentlistpublic.aspx?NodeID=552)

61. Sections 524 and 525 of the Energy Independence and Security Act of 2007, (Public Law 110–140), December 19, 2007

62. Section 104 of the Energy Policy Act of 2005, (Public Law 109–58), August 8, 2005

63. Executive Order 13834, “Efficient Federal Operations”, dated May 17, 2018

64. Executive Order 13221, “Energy-Efficient Standby Power Devices,” August

2, 2001 https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514 https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896 https://www.dhs.gov/sites/default/files/publications/TIC_Ref_Arch_v2.2_2017.pdf https://www.dhs.gov/sites/default/files/publications/TIC_Ref_Arch_v2.2_2017.pdf https://www.voa.va.gov/documentlistpublic.aspx?NodeID=552

65. VA Directive 0058, “VA Green Purchasing Program”, July 19, 2013

66. VA Handbook 0058, “VA Green Purchasing Program”, July 19, 2013

67. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote

Access”, January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

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

69. “Veteran Focused Integration Process (VIP) Guide 3.2”, December 2018, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

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

3.0 SCOPE OF WORK

The Contractor shall provide Project Management, System Review, Documentation Review, Validation Planning and Validation Services.

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE PERIOD

The PoP shall be one (1) 12-month base period with four (4) 12-month option periods.

Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). There are eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, five (5) are set by date:

New Year's Day January 1 Juneteenth June 19 Independence Day July 4 Veterans Day November 11 Christmas Day December 25

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 (6) are set by a day of the week and month:

Martin Luther King's Birthday Third Monday in January Washington's Birthday Third Monday in February Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

4.2 PLACE OF PERFORMANCE

Efforts under this TO shall be performed at Contractor facilities or telework with prior approval. The Contractor shall identify the Contractor’s place of performance in the Task Execution Plan submission.

4.3 TRAVEL

The Government does not anticipate travel under this effort.

5.0 SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

5.1 PROJECT MANAGEMENT

5.1.1 CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall deliver a Contractor Project Management Plan (CPMP) that lays out the Contractor’s approach, timeline, and tools to be used in execution of the contract. The CPMP should take the form of both a narrative and graphic format that displays the schedule, milestones, risks, and resource support.

The initial baseline CPMP shall be concurred upon and updated in accordance with Section B of the contract. The Contractor shall update and maintain the VA PM approved CPMP throughout the PoP.

Deliverable:

A. Contractor Project Management Plan

5.1.2 REPORTING REQUIREMENTS

The Contractor shall provide the Contract Officer’s Representative (COR) with Weekly and Monthly Progress Reports 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. These reports shall reflect data as of the last day of the preceding Week or Month as appropriate.

The Weekly Progress Reports 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. The Contractor shall monitor performance against the CPMP and report any deviations. 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:

• Weekly Progress Report

• Monthly Progress Report

5.2 BLOOD BANK VALIDATION

The Contractor shall perform blood bank validation for a VA Blood Bank location. The validation shall include:

• Installation Qualification (IQ)

• Operational Qualification (OQ)

• Performance Qualification (PQ)

• Computer System Validation

• Risk Assessment

Functions & Workflows to be validated shall include:

1. Critical System Messages

2. Pooled product handling

3. Correct Inventory

4. Computer Crossmatch at Result Entry and Dispense

5. Department Order Entry

6. Discern Expert Rules

A. The Contractor shall test up to 10 blood bank-specific rules for each go-live event only (applicable to all facilities in the event)

7. Assign, Dispense, Emergency Dispense

8. Return Products

9. Final Disposition

10. Modify Crossmatch

11. Modify Products

12. Product Patient Compatibility

13. Receive Products

14. Result Entry

15. Release Products

16. Quarantine Products

17. Flexible Specimen Expiration

18. Interpretation Pattern Verification

19. Printer Verification

20. Product Results

21. Patient Typing and Comments (PTC) Export

22. System Functionality – General blood bank workflow testing for each additional facility

5.2.1 ENTERPRISE BLOOD BANK VALIDATION PLAN

The Contractor shall provide an Enterprise Blood Bank Validation Plan. The Enterprise Blood Bank Validation Plan shall:

• Provide a t-minus schedule for performing and completing site validations prior to go-live.

• Document a template site validation plan to be completed for each site and include:

o the scope of the validation o the approach to validation including all test scenarios/cases o List of software and systems to be validated o Any limitations to the validation o A review of local Standard Operating Procedures

This Enterprise Validation Plan will be approved by the VA PM.

Deliverables:

A: VA PM Approved Enterprise Validation Plan.

5.3 BLOOD BANK VALIDATION EXECUTION

The Contractor shall use the approved Enterprise Validation Plan to create a site validation plan for each site being validated.

The Contractor shall obtain the VA site laboratory blood bank medical director or designee approval of the Validation Plan.

Following VA approval of the Site Validation Plan, the contractor shall execute the validation plan.

During execution the Contractor shall have weekly coordination calls with the PM and site stakeholders.

During the execution, the Contractor shall complete the following documentation which will be included in the Final Validation Report.

• Review of SOPs

• System Review

• Test Script Content Review

• Documentation of the execution of the validation tests scripts

• Evaluation of all test anomalies and/or failures

• Risk Assessment of regulatory requirements to provide traceability from functional testing outcomes to regulatory requirements

• Validation summary and Testing Report

The Final Site Validation report shall be delivered no less than 6 weeks prior to scheduled site go-live to allow for the site Clinical Laboratory Approval Amendments (CLIA) Medical Director review and acceptance.

Deliverables:

A: Approved Site Validation Plan with signatures B: Final Site Validation Report

5.3 SITE BLOOD BANK VALIDATIONS (OPTIONAL TASK 1)

Upon the exercise of this optional task, the Contractor shall perform Blood Bank Validation PWS Section 5.3 for each site identified in the option exercise. All sites in each option exercise shall have the same go-live date.

This optional task may be exercised up to 24 times for up to a total of 109 sites. Specific sites for each go-live will be identified in additional sub-sections of this optional task.

Validation will be completed no later than one month prior to the identified go-live date.

5.3.1 IDAHO, OREGON, WASHINGTON BLOOD BANK VALIDATIONS (OPTIONAL

TASK 1.1)

The Contractor shall perform Blood Bank Validations for the following sites to be completed no later than August 1, 2027, or as agreed to by the VA PM.

Site Name Service Location Boise VA Medical Center Full Bosie, Idaho Portland VA Medical Center Full Portland, Oregon

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

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

6.1.2 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 Technical Architecture (ETA), https://www.ea.oit.va.gov/EAOIT/VA_EA/Enterprise_Technical_Architecture.asp, and VA Identity and Access Management (IAM) approved enterprise design and integration patterns, https://www.oit.va.gov/library/recurring/edp/index.cfm. 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 VA Handbook 6510 VA Identity and Access Management, VA Handbook 0735 Homeland Security Presidential Directive 12 (HSPD-12) Program, 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 Appendix F, “VA System Security Controls”, and VA IAM enterprise requirements 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 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, and NIST Federal Information Processing Standard (FIPS) 201-2. OMB Memoranda M-05-24 and M-19- 17 can be found at:

https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2005/m05- 24.pdf, and https://www.whitehouse.gov/wp-content/uploads/2019/05/M-19-17.pdf respectively. Contractor delivered applications and systems shall be on the FIPS 201-2 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 design pattern as outlined in VA Enterprise Design Patterns.

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.

6.1.3 INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support Internet Protocol Version 6 (IPv6) based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). IPv6 technology, in accordance with the USGv6 Program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices shall support native IPv6 and dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g.

web, email, DNS, ISP services, etc.) shall support native IPv6 and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and dual stack (IPv6 / IPv4) operations.

6.1.4 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). Any deviations must be approved by the VA TIC 3.0 Working Group at vaoisesatic30team@va.gov.

6.1.5 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, currently Windows 10 (64bit), Edge (Chromium based), and 365 Apps for enterprise. Applications delivered to VA and intended to be deployed to Windows 10 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-administrative, standard user rights that have been configured using the United States Government Configuration Baseline (USGCB) and Defense Information Systems Agency (DISA) Secure Technical Implementation Guide (STIG) specific to the particular client operating system being used.

6.1.6 VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT LINE

MANAGEMENT (PLM)

The Contractor shall support VA efforts in accordance with (IAW) the updated Veteran Focused Integration Process (VIP) and Product Line Management (PLM). The major focus of the new VIP is on Governance and Reporting and is less prescriptive, with a focus on outcomes and continuous delivery of value. Product Line Management (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 Playbook and can be found at:

https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 and the PLM Playbook can be found at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946. The PLM Playbook pivots from project-centric to product-centric delivery and contains descriptive practices that focuses on outcomes. The PLM Playbook contains a set of “plays” that implement Development, Security, and Operations (DevSecOps) principles and processes such as automated development, continuous integration/continuous delivery, and release on demand. The PLM Playbook details how product lines implement Lean-Agile principles, methods, practices, and techniques through levels of maturity. VIP and PLM are the authoritative processes that IT projects must follow to ensure development and delivery of IT products.

6.1.7 PROCESS ASSET LIBRARY (PAL)

The Contractor shall perform their duties consistent with the processes defined in the OIT Process Asset Library (PAL). The PAL scope includes the full spectrum of OIT functions and activities, such as VIP 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. The Contractor shall follow the 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 https://www.va.gov/PROCESS/artifacts/maps/process_CONB_ext.pdf. The main PAL can be accessed at www.va.gov/process.

6.1.8 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 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 Vet360 to access personal contact information, if the solution relies on VA Veteran personal contact information data. Vet360 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.

6.1.9 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 Master Person Index (MPI) for identity traits to include the use of the ICN as the Primary Identifier. The Contractor solution may only use a Social Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA.

6.1.10 SOFTWARE AND LICENSING REQUIREMENTS

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

6.2 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.

6.2.1 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 Task Number Tier1 / Low Risk Tier 2 / Moderate

Risk Tier 4 / High Risk

5.1 5.2 5.3 5.4

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.

6.2.2 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor Responsibilities:

a. The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain the appropriate Background Investigation, and are able to read, write, speak, and understand the English language.

b. Within 3 business days after award, the Contractor shall provide a roster of Contractor and Subcontractor employees to the COR to begin their background investigations in accordance with the PAL template artifact. The Contractor Staff Roster shall contain the Contractor’s Full Name, Date of Birth, Place of Birth, individual background investigation level requirement (based upon Section 6.2 Tasks), etc. The Contractor shall submit full Social Security Numbers either within the Contractor Staff Roster or under separate cover to the COR. The Contractor Staff Roster shall be updated and provided to VA within 1 day of any changes in employee status, training certification completion status, Background Investigation level status, additions/removal of employees, etc. throughout the Period of Performance. The Contractor Staff Roster shall remain a historical document indicating all past information and the Contractor shall indicate in the Comment field, employees no longer supporting this contract. The preferred method to send the Contractor Staff Roster or Social Security Number is by encrypted e-mail. If unable to send encrypted e-mail, other methods which comply with FIPS 140-2 are to encrypt the file, use a secure fax, or use a traceable mail service.

c. The Contractor should coordinate with the location of the nearest VA fingerprinting office through the COR. Only electronic fingerprints are authorized. The Contractor shall bring their completed Security and Investigations Center (SIC) Fingerprint request form with them (see paragraph d.4. below) when getting fingerprints taken.

d. The Contractor shall ensure the following required forms are submitted to the COR within 5 days after contract award:

1) Optional Form 306

2) Self-Certification of Continuous Service

3) VA Form 0710

4) Completed SIC Fingerprint Request Form

e. The Contractor personnel shall submit all required information related to their background investigations (completion of the investigation documents (SF85, SF85P, or SF 86) utilizing the Office of Personnel Management’s (OPM) Electronic Questionnaire for Investigations Processing (e-QIP) after receiving an email notification from the Security and Investigation Center (SIC).

f. The Contractor employee shall certify and release the e-QIP document, print, and sign the signature pages, and send them encrypted to the COR for electronic submission to the SIC. These documents shall be submitted to the COR within 3 business days of receipt of the e-QIP notification email. (Note:

OPM is moving towards a “click to sign” process. If click to sign is used, the Contractor employee should notify the COR within 3 business days that documents were signed via e-QIP).

g. The Contractor shall be responsible for the actions of all personnel provided to work for VA under this contract. In the event that damages arise from work performed by Contractor provided personnel, under the auspices of this contract, the Contractor shall be responsible for all resources necessary to remedy the incident.

h. A Contractor may be granted unescorted access to VA facilities and/or access to VA Information Technology resources (network and/or protected data) with a favorably adjudicated Special Agreement Check (SAC), completed training delineated in VA Handbook 6500.6 (Appendix C, Section 9), signed “Contractor Rules of Behavior”, and with a valid, operational PIV credential for PIV-only logical access to VA’s network. A PIV card credential can be issued once your SAC has been favorably adjudicated and your background investigation has been scheduled by OPM. However, the Contractor will be responsible for the actions of the Contractor personnel they provide to perform work for VA. The investigative history for Contractor personnel working under this contract must be maintained in the database of

OPM.

i. The Contractor, when notified of an unfavorably adjudicated background investigation on a Contractor employee as determined by the Government, shall withdraw the employee from consideration in working under the contract.

j. Failure to comply with the Contractor personnel security investigative requirements may result in loss of physical and/or logical access to VA facilities and systems by Contractor and Subcontractor employees and/or termination of the contract for default.

k. Identity Credential Holders must follow all HSPD-12 policies and procedures as well as use and protect their assigned identity credentials in accordance with VA policies and procedures, always displaying their badges, and returning the identity credentials upon termination of their relationship with

VA.

Deliverable:

A. Contractor Staff Roster

6.3 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, MS Word 2000/2003/2007/2010/2019, MS Excel 2000/2003/2007/2010/2019, MS PowerPoint 2000/2003/2007/2010/2019, MS Project 2000/2003/2007/2010/2019, MS Access 2000/2003/2007/2010, MS Visio 2000/2002/2003/2007/2010/2019, AutoCAD 2002/2004/2007/2010, and Adobe Postscript Data Format (PDF).

6.4 PERFORMANCE METRICS

The table below defines the Performance Standards and Acceptable Levels of Performance associated with this effort.

Performance Objective

Performance Standard Acceptable Levels of Performance (Defined in the

QASP)

A. Technical / Quality of Product or Service

1. Demonstrates understanding of requirements.

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

B. Project Milestones and Schedule

1. Established milestones and project dates are met.

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

3. Notifies customer in advance of potential problems

Satisfactory or higher

C. Cost & Staffing 1. Currency of expertise and staffing levels appropriate to perform tasks required.

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

Satisfactory or higher

D. Management 1. Integration and coordination of all activities to execute effort.

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. A Performance Based Service Assessment will be used by the COR in accordance with the QASP to assess Contractor performance.

6.5 FACILITY/RESOURCE PROVISIONS

The Government will provide office space, telephone service and system access when authorized contract staff work at a government location as required in order to accomplish the tasks associated with this PWS. All procedural guides, reference materials, and program documentation for the project and other Government applications will also be provided on an as-needed basis.

The Contractor shall request other Government documentation deemed pertinent to the work accomplishment directly from the Government officials with whom the Contractor has contact. The Contractor shall consider the COR as the final source for needed Government documentation when the Contractor fails to secure the documents by other means. The Contractor is expected to use common knowledge and resourcefulness in securing all other reference materials, standard industry publications, and related materials that are pertinent to the work.

VA may provide remote access to VA specific systems/network in accordance with VA Handbook 6500, which requires the use of a VA approved method to connect external equipment/systems to VA’s network. Citrix Access Gateway (CAG) is the current and only VA approved method for remote access users when using or manipulating VA information for official VA Business. VA permits CAG remote access through approved Personally Owned Equipment (POE) and Other Equipment (OE) provided the equipment meets all applicable 6500 Handbook requirements for POE/OE. All the security controls required for Government furnished equipment (GFE) must be utilized in approved POE or OE. The Contractor shall provide proof to the COR for review and approval that their POE or OE meets the VA Handbook 6500 requirements and VA Handbook 6500.6 Appendix C, herein incorporated as Addendum B, before use. CAG authorized users shall not be permitted to copy, print, or save any VA information accessed via CAG at any time. VA prohibits remote access to VA’s network from non- North Atlantic Treaty Organization (NATO) countries. The exceptions to this are countries where VA has approved operations established (e.g. Philippines and South Korea). Exceptions are determined by the COR in coordination with the Information Security Officer (ISO) and Privacy Officer (PO).

This remote access may provide access to VA specific software such as Veterans Health Information System and Technology Architecture (VistA), ClearQuest, PAL, Primavera, and Remedy, including appropriate seat management and user licenses, depending upon the level of access granted. The Contractor shall utilize government-provided software development and test accounts, documents, and requirements repositories, etc. as required for the development, storage, maintenance, and delivery of products within the scope of this effort. The Contractor shall not transmit, store, or otherwise maintain sensitive data or products in Contractor systems (or media) within the VA firewall IAW VA Handbook 6500.6 dated March 12, 2010. All VA sensitive information shall be protected at all times in accordance with VA Handbook 6500, local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this PWS. The Contractor shall ensure all work is performed in countries deemed not to pose a significant security risk. For detailed Security and Privacy Requirements (additional requirements of the contract consolidated into an addendum for easy reference) refer to ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED and

ADDENDUM B - VA INFORMATION AND INFORMATION SYSTEM

SECURITY/PRIVACY LANGUAGE.

6.6 GOVERNMENT FURNISHED PROPERTY

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

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

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

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

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

1. Fifty-Five (55) laptops.

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

Additionally, if GFE is approved, the Contractor shall provide a status of all reportable GFE as part of the Monthly Status Report as required by PWS paragraph 5.1. For purposes of this report, reportable GFE includes equipment that is furnished by the Government as tangible “personal” property which the Contractor takes possession of, physically leaves a government facility, and needs to be returned the end of Contractor performance. The following information shall be provided for each piece of GFE:

1. Name of Contractor employee assigned to the GFE.

2. Type of Equipment (Make and Model)

3. Tracking Number/Serial Number

4. VA Bar Code

5. Location

6. Value

7. Total Value of Equipment

8. Anticipated Transfer Date to Government

9. Anticipated Transfer Location

6.7 SHIPMENT OF HARDWARE OR EQUIPMENT

Not Applicable

ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED

A1.0 Cyber and Information Security Requirements for VA IT Services The Contractor…