36C10B18R2927-001.docx

ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES (EPCS) CERTIFICATION FOR DEA COMPLIANCE

TAC-18-50924

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Office of Pharmacy Benefit Services

Electronic Prescribing of Controlled Substances (EPCS) Certification

Date: May 31, 2018

TAC-18-50924

PWS Version Number: 1.0

Contents

BACKGROUND

The Office of Pharmacy Benefits Management Services (PBM) is seeking a contract for independent third-party certification of the system used for electronic prescribing of controlled substances (i.e., CPRS and its associated VistA Pharmacy and Kernel patches) and the system used for pharmacy fulfillment of electronically transmitted controlled substance prescriptions (i.e., the VistA Pharmacy package).

The Drug Enforcement Administration’s (DEA) Interim Final Rule (IFR) for Electronic Prescriptions of Controlled Substances requires third-party audit or certification of any system used to electronically prescribe controlled substances or to dispense medications pursuant to electronically transmitted controlled substance prescriptions. The Rule requires recertification “whenever [functionality] related to controlled substance prescription requirements is altered or every two years, whichever occurs first.”

The goal of this contract is to purchase certification services to address the ongoing routine maintenance of VistA software used in in the prescription and dispensing of controlled substance medications, obtain certification for variants in the software when compared to the original national certification, and perform user environment assessments in accordance with DEA’s expectations for the certifying organization to ensure processing integrity at all states of the electronic prescription process. PBM seeks to obtain certification for additional user environment configurations not tested during the initial certification process, detailed examples listed in Task Two (section 5.2) below.

The Interim Final Rule may be reviewed on the DEA website at: http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.pdf or http://www.deadiversion.usdoj.gov/21cfr/cfr/1311/subpart_c100.htm

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, http://www.va.gov/vapubs/

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

14. VA Directive and Handbook 6102, “Internet/Intranet Services,” July 15, 2008

15. 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility Standards,” July 1, 2003

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. 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 by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998

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

21. VA Directive 6500, “Managing Information Security Risk: VA Information Security Program,” September 20, 2012

22. VA Handbook 6500, “Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program,” March 10, 2015

23. VA Handbook 6500.1, “Electronic Media Sanitization,” November 03, 2008

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

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

26. VA Handbook 6500.5, “Incorporating Security and Privacy in System Development Lifecycle”, March 22, 2010

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

28. VA Handbook 6500.8, “Information System Contingency Planning”, April 6, 2011

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, 2016

34. VA Directive 6300, Records and Information Management, February 26, 2009

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

36. NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: a Security Life Cycle Approach, June 10, 2014

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

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

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

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

41. OMB Memorandum M-06-18, Acquisition of Products and Services for Implementation of HSPD-12, June 30, 2006

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

43. 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

44. OMB memorandum M-11-11, “Continued Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors, February 3, 2011

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

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

47. NIST SP 800-116, A Recommendation for the Use of Personal Identity Verification (PIV) Credentials in Physical Access Control Systems, November 20, 2008

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

49. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, Digital Identity Guidelines, June 2017

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

51. NIST SP 800-164, Guidelines on Hardware-Rooted Security in Mobile Devices (Draft), October 2012

52. Draft National Institute of Standards and Technology Interagency Report (NISTIR) 7981 Mobile, PIV, and Authentication, March 2014

53. 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)

54. 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)

55. VA Memorandum “Mandate to meet PIV Requirements for New and Existing Systems” (VAIQ# 7712300), June 30, 2015, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4846

56. Trusted Internet Connections (TIC) Reference Architecture Document, Version 2.0, Federal Interagency Technical Reference Architectures, Department of Homeland Security, October 1, 2013, https://s3.amazonaws.com/sitesusa/wp-content/uploads/sites/482/2015/04/TIC_Ref_Arch_v2-0_2013.pdf

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

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

59. 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)

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

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

62. Executive Order 13693, “Planning for Federal Sustainability in the Next Decade”, dated March 19, 2015

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

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

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

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

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

68. VA Memorandum, “Implementation of Federal Personal Identity Verification (PIV) Credentials for Federal and Contractor Access to VA IT Systems”, (VAIQ# 7614373) July 9, 2015, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

69. VA Memorandum “Mandatory Use of PIV Multifactor Authentication to VA Information System” (VAIQ# 7613595), June 30, 2015, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

70. VA Memorandum “Mandatory Use of PIV Multifactor Authentication for Users with Elevated Privileges” (VAIQ# 7613597), June 30, 2015; https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

71. “Veteran Focused Integration Process (VIP) Guide 2.0”, May 2017, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

72. “VIP Release Process Guide”, Version 1.4, May 2016, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4411

73. “POLARIS User Guide”, Version 1.2, February 2016, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4412

74. VA Memorandum “Use of Personal Email (VAIQ #7581492)”, April 24, 2015, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

75. VA Memorandum “Updated VA Information Security Rules of Behavior (VAIQ #7823189)”, September, 15, 2017, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

SCOPE OF WORK

The Contractor shall provide services, materials, and the equipment required to conduct the certification test and to provide certification test support during the period of performance for this contract The Contractor shall determine if the system meets the current requirements of the DEA’s regulations for electronic prescribing, as set forth in § 1311.300 Application provider requirements—Third-party audits or certifications (available at : http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.pdf).

PERFORMANCE DETAILS

PERFORMANCE PERIOD

The PoP shall be 12 months from award date with 4 option periods of 12 months each.

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

There are ten (10) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, four 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 at Contractor facilities. The Contractor shall identify the Contractor’s place of performance in their Task Execution Plan submission.

TRAVEL

The Government anticipates travel under this effort to perform the tasks associated with the effort, as well as to attend program-related meetings or conferences throughout the PoP.

The total estimated number of trips in support of the program related meetings for this effort is one (1). Anticipated locations include the following, estimated at three (3) days in duration:

1. Nashville, TN

SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

Audit, verify, and certify the VA Electronic Prescriptions for Controlled Substances (EPCS) application for compliance with the requirements of 21 CFR part 1311.

PROJECT MANAGEMENT

REPORTING REQUIREMENTS

The Contractor shall provide the COR with audit results in electronic form using Microsoft Office compatible application within 21 calendar days of request, which shall cover all work completed during the audit. 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 Audit Results and Certification shall be in accordance with the EPCS compliance with 21 CFR part 1311. This will include details of portions of the EPCS that did not meet the requirements of 21 CFR part 1311 and why.

Deliverable:

1. Evaluation and Certification reports

TASK REQUIREMENTS

The Drug Enforcement Administration’s (DEA) Interim Final Rule (IFR) for Electronic Prescriptions of Controlled Substances requires third-party audit or certification of any system used to electronically prescribe controlled substances or to dispense medications pursuant to electronically transmitted controlled substance prescriptions. The Rule requires recertification “whenever [functionality] related to controlled substance prescription requirements is altered or every two years, whichever occurs first.”

The Contractor shall audit and certify CPRS and VISTA EPCS applications in accordance with DEA’s IFR.

The Contractor shall provide certification services to address the ongoing routine maintenance of VistA software used in in the prescription and dispensing of controlled substance medications, obtain certification for variants in the software when compared to the original national certification, and perform user environment assessments in accordance with DEA’s expectations for the certifying organization to ensure processing integrity at all states of the electronic prescription process. PBM seeks to obtain certification for additional user environment configurations not tested during the initial certification process, detailed examples listed in Task Two (section 5.2) below.

The IFR may be reviewed on the DEA website at: http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.pdf or http://www.deadiversion.usdoj.gov/21cfr/cfr/1311/subpart_c100.htm.

TASK ONE

The Contractor shall perform a full audit and certify the CPRS and VistA EPCS applications during the base year and upon government request during option years.

(h) For electronic prescription applications, the third-party auditor or certification organization must make the following determinations:

(1) If the information required in §1306.05(a) of the regulation, the indication that the prescription was signed as required by §1311.120(b)(17) or the digital signature created by the practitioner's private key, if transmitted, and the number of refills as required by §1306.22 of this chapter, cannot be consistently and accurately recorded, stored, and transmitted, the third-party auditor or certification organization must indicate that the application does not meet the requirements of this part.

(2) If other information required under the regulation cannot be consistently and accurately recorded, stored, and transmitted, the third-party auditor or certification organization must indicate that the application has failed to meet the requirements for the specific information and should not be used to create, sign, and transmit prescriptions that require the additional information.

(i) For pharmacy applications, the third-party auditor or certification organization must make the following determinations:

(1) If the information required in §1306.05(a) of this chapter, the indication that the prescription was signed as required by §1311.205(b)(6), and the number of refills as required by §1306.22 of this chapter, cannot be consistently and accurately imported, stored, and displayed, the third-party auditor or certification organization must indicate that the application does not meet the requirements of this part.

(2) If the pharmacy application accepts prescriptions with the practitioner's digital signature, the third-party auditor or certification organization must indicate that the application does not meet the requirements of this part if the application does not consistently and accurately import, store, and verify the digital signature.

(3) If other information required under this chapter cannot be consistently and accurately imported, stored, and displayed, the third-party auditor or certification organization must indicate that the application has failed to meet the requirements for the specific information and should not be used to process electronic prescriptions that require the additional information.

Evaluations requested during the Base period of performance:

· Initial evaluation and certification of latest full release of CPRS (v32) and VisTA ECPS applications.

Deliverables:

1. Evaluation and Certification reports for current major release of CPRS

1. Evaluation and Certification reports for current major release of VistA

TASK TWO (Time and Materials) The Contractor shall perform audits and certifications according the regulations stated in section 5.2.2 for all incremental and patched releases of CPRS and VisTA.

· Ongoing certification of CPRS incremental version releases.

· Ongoing certification for VistA Pharmacy incremental version releases.

· Evaluation and certification of VA functionality for ‘Inbound Electronic Prescribing’ if released during period of performance

Deliverables:

A. Evaluation and Certification reports for current incremental release of CPRS B. Evaluation and Certification reports for current incremental release of VistA C. Evaluation and Certification reports for Inbound Electronic Prescribing

GENERAL REQUIREMENTS

ENTERPRISE AND IT FRAMEWORK

ONE-VA TECHNICAL REFERENCE MODEL

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OI&T Technical Reference Model (One-VA TRM). One-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. One-VA TRM includes the Standards Profile and Product List that collectively serves as a VA technology roadmap. Architecture, Strategy, and Design (ASD) has overall responsibility for the One-VA TRM.

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), http://www.ea.oit.va.gov/VA_EA/VAEA_TechnicalArchitecture.asp, and VA Identity and Access Management (IAM) approved enterprise design and integration patterns, http://www.techstrategies.oit.va.gov/enterprise_dp.asp. 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 the VA Handbook 6510 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-04-04, M-05-24, M-11-11, and NIST Federal Information Processing Standard (FIPS) 201-2. OMB Memoranda M-04-04, M-05-24, and M-11-11 can be found at: https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy04/m04-04.pdf, https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-24.pdf, and https://obamawhitehouse.archives.gov/sites/default/files/omb/memoranda/2011/m11-11.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 Veteran Index (MVI) to provision identity attributes, if the solution relies on VA user identities. MVI 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 VAIQ# 7712300 Mandate to meet PIV requirements for new and existing systems. https://www.voa.va.gov/DocumentView.aspx?DocumentID=4846

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 the latest Internet Protocol Version 6 (IPv6) based upon the directives issued by the Office of Management and Budget (OMB) on August 2, 2005 (https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-22.pdf) and September 28, 2010 (https://cio.gov/wp-content/uploads/downloads/2012/09/Transition-to-IPv6.pdf). IPv6 technology, in accordance with the USGv6 Profile, NIST Special Publication (SP) 500-267 (https://www.nist.gov/programs-projects/usgv6-technical-basis-next-generation-internet), the Technical Infrastructure for USGv6 Adoption (http://www-x.antd.nist.gov/usgv6/index.html), and the NIST SP 800 series applicable compliance (http://csrc.nist.gov/publications/PubsSPs.html) 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/or 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/or dual stack (IPv6/ IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and/or dual stack (IPv6/ IPv4) operations. Guidance and support of improved methodologies which ensure interoperability with legacy protocol and services in dual stack solutions, in addition to OMB/VA memoranda, can be found at: https://www.voa.va.gov/documentlistpublic.aspx?NodeID=282.

TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M08-05 mandating Trusted Internet Connections (TIC) (https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2008/m08-05.pdf), M08-23 mandating Domain Name System Security (NSSEC) (https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2008/m08-23.pdf), and shall comply with the Trusted Internet Connections (TIC) Reference Architecture Document, Version 2.0 https://s3.amazonaws.com/sitesusa/wp-content/uploads/sites/482/2015/04/TIC_Ref_Arch_v2-0_2013.pdf.

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 7 (64bit), Internet Explorer 11 and Microsoft Office 2010. In preparation for the future VA standard configuration update, end user solutions shall also be compatible with Office 365 ProPlus and Windows 10. However, Office 365 ProPlus and Windows 10 are not the VA standard yet and are currently approved for limited use during their rollout, we are in-process of this rollout and making them the standard by OI&T. Upon the release approval of Office 365 ProPlus and Windows 10 individually as the VA standard, Office 365 ProPlus and Windows 10 will supersede Office 2010 and Windows 7 respectively. Applications delivered to the VA and intended to be deployed to Windows 7 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 System Center Configuration Manager (SCCM) VA’s current desktop application deployment tool. Signing of the software code shall be through a vendor provided certificate that is trusted by the 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 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.

VETERAN FOCUSED INTEGRATION PROCESS (VIP)

The Contractor shall support VA efforts IAW the Veteran Focused Integration Process (VIP). VIP is a Lean-Agile framework that services the interest of Veterans through the efficient streamlining of activities that occur within the enterprise. The VIP Guide can be found at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371. The VIP framework creates an environment delivering more frequent releases through a deeper application of Agile practices. In parallel with a single integrated release process, VIP will increase cross-organizational and business stakeholder engagement, provide greater visibility into projects, increase Agile adoption and institute a predictive delivery cadence. VIP is now the single authoritative process that IT projects must follow to ensure development and delivery of IT products

PROCESS ASSETT LIBRARY (PAL)

The Contractor shall utilize PAL, the OI&T-wide process management tool that assists in the execution of an IT project (including adherence to VIP standards). PAL serves as an authoritative and informative repository of searchable processes, activities or tasks, roles, artifacts, tools and applicable standards or guides to assist project teams in facilitating their VIP compliant work.

SECURITY AND PRIVACY REQUIREMENTS

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.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor Responsibilities:

1. 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.

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.

1. 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.

b. 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 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).

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).

1. 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.

1. 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.

1. 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.

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.

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, displaying their badges at all times, and returning the identity credentials upon termination of their relationship with VA.

Deliverable:

A. Contractor Staff Roster

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

PERFORMANCE METRICS

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

2. Efficient and effective in meeting requirements

3. Meets technical needs and mission requirements

4. Provides quality services/products 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. A Performance Based Service Assessment will be used by the COR in accordance with the QASP to assess Contractor performance.

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 of 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 exception 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, document 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.

GOVERNMENT FURNISHED PROPERTY

Not Applicable

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 certification and accreditation.

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 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 COR, CO, the PM, and the Information Security Officer (ISO) must be notified and verify all security requirements have been adhered to.

Each documented initiative under this contract incorporates VA Handbook 6500.6, “Contract Security,” March 12, 2010 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), and will be tracked therein. The TMS may be accessed at https://www.tms.va.gov. If you do not have a TMS profile, go to https://www.tms.va.gov and click on the “Create New User” link on the TMS 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 One-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 Handbook 6102, Internet/Intranet Services, including applicable amendments and changes, if the Contractor’s work includes managing, maintaining, establishing and presenting information on VA’s Internet/Intranet Service Sites. This pertains, but is not limited to: 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): http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=409&FType=2

Internet/Intranet Services Handbook 6102 is posted at (copy and paste following URL to browser): http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=410&FType=2

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

On August 7, 1998, Section 508 of the Rehabilitation Act of 1973 was amended to require that when Federal departments or agencies develop, procure, maintain, or use Electronic and Information Technology, that they shall ensure it allows Federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. Section 508 required the Architectural and Transportation Barriers Compliance Board (Access Board) to publish standards setting forth a definition of electronic and information technology and the technical and functional criteria for such technology to comply with Section 508. These standards have been developed and published with an effective date of December 21, 2000. Federal departments and agencies shall develop all Electronic and Information Technology requirements to comply with the standards found in 36 CFR 1194.

Section 508 – Electronic and Information Technology (EIT) Standards

The Section 508 standards established by the Architectural and Transportation Barriers Compliance Board (Access Board) are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure Electronic and Information Technology (EIT). These standards are found in their entirety at: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards. A printed copy of the standards will be supplied upon request. The Contractor shall comply with the technical standards as marked:

Equivalent Facilitation Alternatively, offerors may propose products and services that provide equivalent facilitation, pursuant to Section 508, subpart A, §1194.5. Such offerors will be considered to have provided equivalent facilitation when the proposed deliverables result in substantially equivalent or greater access to and use of information for those with disabilities.

Compatibility with Assistive Technology The Section 508 standards do not require the installation of specific accessibility-related software or the attachment of an assistive technology device. Section 508 requires that the EIT be compatible with such software and devices so that EIT 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 identified Section 508 standards’ requirements for accessibility and must include final test results demonstrating Section 508 compliance.

Deliverables should meet applicable accessibility requirements and should not adversely affect accessibility features of existing EIT technologies. The Government reserves the right to independently test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon delivery.

Automated test tools and manual techniques are used in the VA Section 508 compliance assessment.

Deliverables:

A. Final…