S02 - Attachment A - IDIQ_PWS KBS Standards and Interoperability.docx

Performance Work Statement (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Office of Health Informatics (OHI) Clinical Informatics and Data Management Office (CIDMO) Knowledge Based Systems (KBS)

INTEGRATED HEALTH STANDARDS & INTEROPERABILITY SUPPORT

INDEFINITE DELIVERY/INDEFINITE QUANTITY (IDIQ)

April 20, 2021 Version: 1.0

1.0 BACKGROUND

The Veterans Health Administration (VHA) Office of Health Informatics (OHI), Clinical Informatics and Data Management Office (CIDMO), Knowledge Based Systems (KBS), Standards & Interoperability (S&I) Division provides strategic guidance, subject matter and policy expertise concerning standards implementation in VA information technology (IT) systems. Standards & Interoperability covers a continuum of activities including the identification of VA requirements for health interoperability standards/profiles, to the development of standards/profiles with federal and private sector standards development organizations (SDO) and standards related organizations (SRO), development and sustenance of internal VA and external provider collaborative engagements required for supporting requisite Health Information Technology (HIT) architecture, systems operability and interoperability, the development of implementation models, prototypes, and implementation guidance and for providing a range of standards-related expertise to VA development teams as needed

KBS Summarization of Core Competencies

KBS works to ensure that health systems “talk” with one another by ensuring Veterans and staff have accurate, timely, and correct healthcare information at the point of care. KBS partners with other Federal agencies to enhance clinical terminology by supporting interoperability efforts for safe and efficient health care. KBS provides a standards-based foundation for patient-specific information and clinical knowledge to be computable, shareable, and accurate where and when needed to improve Veteran care. KBS is comprised of 4 pillars:

Terminology: Provides expert clinical terminology consultation, development, mapping, modeling and tooling to support semantic interoperability and reasoning capabilities in health records.

Clinical Decision Support (CDS): Provides subject matter expertise on CDS to internal and external collaborators and supports design and implementation of VHA’s current and future CDS strategy by identifying and exploring CDS capabilities needed to optimally support patient care.

Informatics Architecture (IA): Defines VA strategy and architecture as it relates to representation of patient-specific clinical data and knowledge within VA health information systems and with technical methodologies used to process data for patient care, quality assurance, and secondary uses.

Standards and Interoperability (S&I): Provides expert health standards development engagement and consultation, contributing to a common framework for functional and semantic interoperability by sharing VA requirements and supporting solutions to achieve intelligent health information exchange that extends to enhanced patient care.

Standards & Interoperability (S&I)

S&I covers the full spectrum of health standards adoption, from the identification of health standards requirements, to the development of standards, standards profiles, and implementation guidance by Standards Development Organizations (SDO) and Standards Related Organizations (SRO), to the implementation and utilization of open-source standards by VA development project teams to help foster semantic interoperability within the VA enterprise and externally with federal, civilian and community stakeholders.

VA engages with SDOs and SROs to identify existing standards/profiles/industry guidance available for use within the VA, assesses health standards gaps, improves existing standards/profiles/industry guidance, and develops new standards/profiles/industry guidance to meet the evolving needs a rapidly changing healthcare environment. The S&I team primarily assumes leadership or active participation roles within the standards community to ensure that VA’s requirements are represented to support seamless Veteran care.

The S&I team gathers information about industry-wide healthcare information technology trends and initiatives and identifies related health standards requirements. The S&I team actively participates in and establishes leadership roles within various SDOs/SROs to engage, influence, and become early-adopters of emerging health standards/profiles. The S&I team reviews and makes recommendations on artifacts produced by various health standards organizations and other federal health service entities to ensure that VA requirements are represented and that it is compatible with the existing or future, planned state architecture.

The S&I team collaborates with VA partners such as the Office of Information and Technology (OI&T) and the Office of Community Care (OCC), as well as external partners such as the Department of Health and Human Services (HHS) and the Department of Defense (DoD). The S&I team also supports open-source tooling, health information modeling and health standards architecture in the health information technology (HIT) community with organizations like Health Level 7 (HL7), the Object Management Group (OMG), Logica, and others.

VA SDO/SRO leadership and/or participation includes but is not limited to the follow health standards organizations.

· Health Level Seven (HL7) – www.hl7.org

· Logica – www.logicahealth.org

· Object Management Group (OMG) – http://www.omg.org/

· Integrating the Healthcare Enterprise (IHE) – http://www.ihe.net/

· Healthcare Information and Management Systems Society (HIMSS) – www.himss.org

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, “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, 2019

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

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, 2011

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, 2016

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

35. VA Directive 6300, Records and Information Management, September 21, 2018

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 Identification Standard for Federal Employees and Contractors, February 3, 2011

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

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 services to support Standards & Interoperability (S&I) for the Office of Health Informatics (OHI). The contractor shall primarily support Knowledge Based Systems (KBS) within the Clinical Informatics & Data Management Office (CIDMO) division but may support other S&I initiatives within OHI as determined and requested by the Government.

The contractor shall collaborate between business owners, health standards architects, VA project teams, industry experts, and standards-related organizations to accomplish successful, open-source health standards-based solutions to meet VA’s needs. The contractor shall engage in VA, Government, and industry efforts to advance data and knowledge sharing in support of a seamless Veteran care experience. Whether working collaborative with VA project teams, such as the EHR Modernization (EHRM) Program, or engaging in workgroups to advance standards such as HL7 Fast Healthcare Interoperability Resources (FHIR), the contractor shall provide support to advance, consume, implement, and improve industry standards and their usage in support of Veteran care and wellness.

The contractor shall advance the clinical decision support agenda and improvements in availability and accuracy of patient data, and support improvement in interoperability, clinical knowledge and workflow. The contractor shall provide support services in the following four (4) Technical Functional Areas:

1. Program and Project Management, and Knowledge Management

2. SDO, Industry, and Government Project Engagement

3. Interoperability Strategy and Architecture

4. VA Standards Advancement and Adoption

This PWS provides general requirements (i.e. undefined) and specific requirements (i.e. predefined). The Technical Functional Areas (listed above) are described in Section 5.0 below. This section encompasses the work to be completed throughout the IDIQ, and provides both predefined and undefined deliverables associated within each functional area. Additional deliverables may be added within the functional areas, if they are determined to be within scope and shall be further defined within individual Task Orders. Although this IDIQ contains specific requirements and some defined general requirements, this does not limit the scope of this IDIQ. Requirements shall fall within the areas described in Sections 5.0 and 6.0; however, this IDIQ covers all activities related to the Standards and Interoperability (S&I) life cycle. Furthermore, as the general requirements become further defined as a result of future Task Order awards, they may be incorporated into this IDIQ on an as needed basis to facilitate future ordering.

4.0 GENERAL REQUIREMENTS

The Contractor shall provide and/or acquire the services, hardware, and software required by individual Task Orders pursuant to the general requirements specified below.

4.1 Contract Type

This is a single award Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Individual Task Orders shall be issued on a performance-based Firm-Fixed-Price (FFP) basis.

4.2 Period of Performance

The period of performance for the IDIQ contract shall be a three-year ordering period.

Each Task Order (TO) issued under this IDIQ will specify the Period of Performance (PoP) for that TO.

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

4.3 Place of Performance

The place of performance shall be identified in individual Task Orders. Locations will be Government or Contractor sites within the continental United States (CONUS).

4.4 Travel

Travel shall be in accordance with individual Task Order requirements. Travel details must be provided to, and approved by, the Contracting Officer’s Representative (COR) or the Government designee prior to the commencement of travel. All travel shall be in accordance with the Federal Travel Regulations (FTR). OCONUS travel may require additional authorization and approvals as specified in the individual Task Order.

4.5 Formal Acceptance or Rejection of Deliverables

The Government will review each deliverable within ten (10) business days and provide comments. The contractor shall have five (5) business days to incorporate the Government’s comments and make appropriate revisions.

4.6 Confidentiality and Non-Disclosure

It is agreed that:

1. The preliminary and final deliverables, as well as all associated working papers and other material deemed relevant by VA that have been generated by the contractor in the performance of this contract, are the exclusive property of the U.S. Government and shall be submitted upon request to the CO at the time of final delivery.

1. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this contract. No information shall be released by the contractor. Any request for information relating to this contract presented to the contractor shall be submitted to the CO for response.

1. Press releases, marketing material, or any other printed or electronic documentation related to this contract shall not be publicized without the written approval of the CO.

4.7 Contracting Officer’s Representative (COR)

A COR will be designated for each Task Order. The COR will be appointed by the CO and duties delegated in an appointment letter. The COR designated for each Task Order will provide the Contractor access to all available Government furnished information, facilities, material, equipment, services, among others as required to accomplish each Task Order. Contract surveillance duties will be defined and accomplished in accordance with the Quality Assurance Surveillance Plan (QASP) and, if a unique QASP is required at the TO Level, that QASP shall take precedence.

4.8 Contractor Project Manager (PM)

The Contractor shall establish a single management focal point, the PM, to accomplish the administrative, managerial and financial aspects of this contract and all subsequent Task Orders.

5.0 Technical Functional Areas

Individual Task Orders may encompass more than one technical functional area listed below. Further technical functional area details are described to provide greater insight into the complexity and uniqueness of some potential Task Order requirements covered by this PWS. Functional area requirements are not mutually exclusive and may apply across multiple functional areas.

Predefined Deliverables

The deliverables associated with the tasks below, described as predefined, are specific in nature. Individual task orders may encompass more than one specific requirement listed below. Tasks identified as predefined in this section will be ordered by simply applying the quantity the government requires to the predetermined, firm-fixed-price outlined in the price schedule of the Basic IDIQ (not-to-exceed travel costs will be included as determined necessary).

Undefined Deliverables

The deliverables associated with the tasks below, described as undefined are general in nature (i.e. not defined). Individual task orders may encompass more than one general requirement listed below. The details provided for the general requirements are described to provide greater insight into the complexity and uniqueness of some potential task order requirements covered by this basic IDIQ PWS. General requirements are not mutually exclusive and may apply across multiple requirements. To facilitate the award of task orders under this section, the Government will issue a Request for Quotation (RFQ) that will include a detailed PWS with specific tasks and deliverables. The RFQ will require the contractor to provide the appropriate labor categories from the basic IDIQ and the corresponding level of effort. The result will be a firm-fixed-price task order award.

The Predefined and Undefined Deliverables described below do not encompass all potential deliverables that may be included at the task order level. Additional deliverables may be identified at the task order level that are determined to be within the IDIQ Scope of Work.

5.1 Program and Project Management, and Knowledge Management

The contractor shall provide for comprehensive knowledge management and knowledge transfer to VA personnel and partners for all requirements. The contractor shall employ methods such as stakeholder outreach, presentations, papers, meetings and virtual workspace content management.

The contactor shall apply Project Management Institute (PMI) - http://www.pmi.org/, best practices to all project tasks in a fashion such that activities are traceable against requirements and meet each objective.

The Contractor shall hold a comprehensive Program Management Review (PMR) with the KBS Standards and Interoperability (S&I) program office, unless cancelled by the client in advance. The Contractor shall develop the meeting content and populate the predefined template. The Contractor shall be responsible for meeting coordination and facilitation, working with Government leadership to determine an appropriate recurring schedule.

The Contractor shall use project management best practices to manage the tactical activities that are encompassed within each task order in this IDIQ, including but not limited to resource management, communication and meeting coordination/facilitation, deliverable schedule management, change management, risk management, and status reporting to Contractor and Government programmatic leadership. The Contractor shall ensure that programmatic leadership is proactively aware of progress, challenges, limitations and/or risks associated within the various task-specific areas of the program, including participation as needed or appropriate within tactical meetings or activities.

The Contractor shall create and maintain a project management plan that lays out the Contractor’s approach, timeline (via an Integrated Master Schedule (IMS)), and tools to be used in execution of task orders within this IDIQ. The contractor project management plan should take the form of both a narrative and graphic format that displays the schedule, milestones, risks and resource support. The contractor project management plan shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc reporting requests as identified within the PWS. Once established and approved, the Contractor shall provide regular updates to the IMS as necessary or required to support the program.

Promulgating awareness of standards, their intended usage, and corresponding implementation considerations and issues is a principal objective of KBS. In support of this objective, the Contractor’s project team shall manage and administer a knowledge management program. This includes but is not limited to:

· Developing a Communications and Stakeholder Engagement Plan, to include both internal and industry stakeholders, to promulgate awareness of key KBS S&I activities. The plan is to include a social media strategy, VA-internal communications, and industry communities including SDO/SRO engagements.

· Executing the Communications and Stakeholder Engagement Plan as part of outreach and stakeholder engagement efforts. Activities include authoring or contributing to informative internal VA or external short articles, collaborating with SDO/SRO organizations in their media efforts, and maintenance of (or collaboration with) VA social media channels.

· Reviewing industry literature and key communications to assemble an artifact of key HIT activities, emerging standards, relevant articles influencing standards work and policy, and events of relevance to KBS and KBS stakeholders.

· Providing content and support for a “Standards Newsletter” or media/outreach campaign providing periodic and timely updates on standards-related issues.

· Organizing, facilitating, conducting, and hosting a series of educational sessions , conducted as webinar/phone teleconferences on a variety of topics germane to VA business needs around interoperability and standards. The Contractor shall work with Government personnel to identify candidate topics, secure commitments from internal and external speakers, and facilitate training sessions, “roundtable” discussion forums, and alternative presentation approaches to allow for VA community interaction and education.

· Improving on-demand educational resources, such as enhanced web/wiki presence, extended knowledgebase contributions to the KBS SharePoint and other knowledge repositories.

· Defining, developing, enhancing, extending, and participating in delivery of a health interoperability curriculum, developing and potentially delivering topic-specific educational activities to enhance skillsets within the VA community around key standards themes or approaches. This may manifest in multiple modalities: in-person training, webinar, recorded presentation, or teleconference/videoconference. Topics will draw from standards work supported within Industry engagement, Applied Standards, or Standards Strategy activities.

The Contractor shall maintain KBS’ Knowledge Management Repository, serving as the authoritative source and collection of standards, standards-references, implementation guidance, point-of-view white-papers, recommended best-practices, and other standards-relevant artifacts. The repository may either be a hosted offering that is provided elsewhere within VA/VHA, or a standalone offering, subject to policy and Government guidance. The asset will not only house VA- and contractor-produced artifacts, but will contain links to appropriate industry resources, including public/published standards, educational materials, and references.

The Contractor shall facilitate the population and metadata management of content within the repository, including the identification of candidate content, loading, classifying, metadata tagging, and management of standards-related information. The content of the repository shall be Contractor-administered, with self-entered content being assessed for accuracy and consistency in tagging and classifications applied. The Contractor shall provide instructions to allow for the self-entry of new content by individual contributors. The Contractor shall ensure that managed lists (such as Key Performance Indicators, SDO Project POCs, Stakeholders, etc.) are maintained and updated on a regular basis.

The Contractor shall recommend enhancements to improve the efficacy and usability of the Repository which will be documented and reviewed with the Government. Proposed and approved changes shall be prioritized and applied into the environment.

Predefined Deliverables:

A. Program Management Review (PMR) B. Project Management Plan (PMP) C. Integrated Master Schedule (IMS) D. Communications and Stakeholder Engagement Plan E. HIT Industry Scan Summary Report F. Standards Newsletter G. Standards Education Sessions

Undefined Deliverables: Deliverables will be described within each TO. The quantity and detail of the deliverables will depend on the scope of the specific project. Some examples of undefined TO deliverables include article content and contributions, presentation development or support, standards education training and curriculum development and execution, knowledge management repository planning, analysis, and management.

5.2 SDO, Industry, and Government Project Engagement

To assure that industry standards are fit for purpose to support Veteran needs, a sustained commitment to participating in industry standards bodies and consortia is essential. It is only through ongoing and regular participation that early insight into emerging relevant work can be gained, and the standards evolutionary process necessitates involvement in the development and maturation of the standard before it progresses to formal voting and ballot stages. Note that this participation will be initiative (goal) based, necessitating involvement in one or multiple bodies or workgroups to achieve the objective, and driven by KBS program offices. The Contractor shall support VA engagement in multiple standards or industry bodies, with an emphasis on furthering data, knowledge, and process interoperability. Participation will be driven by strategic objectives identified by the Government, with involvement from the Contractor team supporting objective-based participation.

The contractor shall assess the efficacy of existing standards to address VA needs in the following areas: security and privacy, clinical decision support, order set management, data representation and format to support computer-based inferencing, data format standards, data transfer standards, expression languages for clinical workflow, and system interchange standards protocols. The contractor shall prioritize and emphasize recommendations based on standards gap areas where the absence of implementation guidance for a standard is adversely affecting seamless Veteran care (e.g. Care Coordination, FHIR, Community Partnerships). Activities include:

· Identification, gap analysis, and engagement recommendations to support VA modernization priorities in standards adoption and implementation guidance.

· Active participation in the SDO/SRO community for the advancement of standards supporting a seamless Veteran care experience (i.e. HL7, OMG/BPM+ Health IHE), including inpatient, outpatient, long-term care, community care, and tele- and home-health.

The Contractor shall support and participate in cross-agency and cross-Government health IT activities, including intra-Governmental workgroups and forums, to include efforts from the Department of Health and Human Services, the Federal Electronic Health Record Modernization (FEHRM)(previously known as Interagency Program Office IPO)), cross Department workgroups for Unique Device Identifier (UDI) adoption, and others.

The Contractor shall engage, at the direction of the Government, directly within the SDO community. The degree of engagement or organizational posture relative to each effort will be determined by the Government, consisting of activities such as:

· Initiative (or Workgroup) Leadership

· Active Participation

· SDO/SRO Activity Monitoring

Content contributions to SDO/SRO’s may take a variety of forms and will be generically referenced as Proposed Standards Artifacts. The contractor shall draft proposed standards (or portions of standards) to address shortcomings in existing, available standards that adversely impact Veteran care. In order to mitigate issues that have been identified, the Contractor shall develop proposed technical content for contribution to the respective SDO/SRO’s for consideration and inclusion in their standards work. These contributions may be of several formats, including but not limited to technical specifications, implementation recommendations or guidance, application programming interfaces (APIs), data constructs or representations (e.g., HL7 FHIR Resources), information models, workflow models, semantic models, and architectures.

The contractor shall develop Proposed Standards Artifacts on behalf of VA, with the intention of contributing that work into the SDO community for validation, ballot, or acceptance. It is recognized that some of these artifacts will be created de novo, and others will be extensions, adaptations, or enhancements of existing works.

The Contractor shall survey emergent standards activities to identify areas of high-impact and potential high-risk, engaging within community efforts to advocate for VA needs, to provide content and subject expertise, and to facilitate advancement of VA priorities. This may take the form of the following, as examples:

· Identify, convene, and participate in “Connectathon” tracks or activities in support of VA business priorities.

· Collaborate with open implementation efforts, such as open-source projects or community-sourced activities, to identify and mitigate risks associated with standards determined to have promise or potential benefit to Veterans and VA.

· Identify technical, skillset, or policy gaps adversely affecting VA adoption of candidate standards, and document mitigation strategies to close those gaps.

· Engage in advancement of reference implementation activities, to advance industry adoption of standards advantageous to VA interoperability objectives.

Frequently in the industry standards community, efforts stumble or achieve sub-optimal results due to a lack of enablement support. At the direction of the Government, the Contractor shall provide enablement support to specified government or industry workgroups and/or designated workgroups/activities. This support includes activities such as capturing and posting of minutes and other documents, management of workgroup schedules and calendar management, task management of activities underway, and meeting facilitation. Efforts will be under the direction of the designated SDO/workgroup lead, subject to approval of the Government.

The Contractor shall facilitate, conduct, and contribute to the VA ballot review processes (or corresponding standards validation/voting efforts) on behalf of VA stakeholders with alignment to VA priorities. The Contractor shall engage and support VA stakeholders in their reviews of said content to reduce or remove administrative burdens from VA Subject Matter Experts while benefitting from their inputs to the process. Where possible, the Contractor shall identify partner organizations to foster community consensus among like-minded organizations, advancing VA interests and reducing review burden. Additionally, the Contractor shall provide direct SME content reviews in areas of interoperability and compliance within review processes. The Contractor shall facilitate establishing a VA position on ballotable items, and support VA voting.

Defined Deliverables:

A. SDO/SRO Engagement B. Proposed Standards Artifacts C. SDO/SRO Ballot Reviews

Undefined Deliverables:

The undefined deliverables will be described within each TO. The quantity and detail of the deliverables will depend on the scope of the specific task order and might include items such as connectathon participation or leadership, reference implementation activity, industry project enablement support, ballot briefings, ballot comment reconciliation, and industry project summaries.

5.3 Interoperability Strategy and Architecture

Maintaining focus on the ability for interoperability standards to support VA’s needs and mission not only today, but in the future, necessitates maintaining a strategic focus. The contractor shall address the trajectory and target-state of the industry, considering how best to identify potential opportunities for advancement both of industry capability and VA’s consumption of that innovation to best serve Veteran needs. Looking at CDS, Clinical Quality and Best Practices, “state of the industry,” and other factors such as security and privacy, the Contractor shall assist the VA to both influence and consume industry priorities and innovation. The Contractor shall amplify emerging standards work to achieve that state, and position VHA to best take advantage of and interact with industry organizations and resources. The Contractor shall provide strategic planning for the alignment of relevant standards necessary for seamless Veteran care (care coordination, remote care delivery, mobile healthcare, telemedicine, security, and privacy) within VA programs that can take on several forms with a variety of intents:

· Recommendation Assessments, including an analysis of alternatives and establishment of a recommended approach or strategy.

· Strategic Plan, which includes evaluation of an environment or business context in consideration of a set of objectives, to determine a recommended strategy toward achieving those objectives.

· Gap Analysis, looking at competing efforts or activities and determining the differences between them, and potential approaches to remediate identified gaps.

· Gap Remediation, which would involve advancement of standards activities (such as the development of proposed standards content, ballot material, white papers, models, maps) to address identified shortcomings in an identified artifact.

Each activity will be ascribed a rough-order-of-magnitude (ROM) sizing (Small or Large), in collaboration with the Contractor for concurrence. These assessments/consultations may be requested singly or severally as required by VA. The program office will provide a detailed description, complexity level, due date, and required outputs/deliverables prior to assigning an assessment/consultation activity.

The Contractor shall provide expert-level ongoing interoperability strategy expertise to help develop and mature VHA’s interoperability strategy. The intent of the effort is to best position VHA to most effectively provide seamless care among multiple organizations and institutions involved in a Veteran’s care, providing as seamless an experience as possible while safeguarding Veteran privacy. This necessitates not only remaining attuned to where the HIT industry is heading, but in exerting VA influence within the industry in an informed and enlightened manner to drive the best possible outcomes.

Given that a substantial portion of VA care is delivered in the community, and often in organizations with no fiduciary ties to VA, it is essential that VA participate in and influence the national Health Information Technology (HIT) landscape to advance standards, frameworks, and interoperability platforms to better allow sharing among health provider organizations. In collaboration with the Government, the Contractor shall identify communities of practice advancing this agenda, recommending an engagement and participation strategy to advance this topic. The Contractor shall participate in the selected efforts, representing VA requirements and interests. This participation includes activities such as:

· Participation in working meetings to advance HIT industry architecture and interoperability.

· Contribution of use cases, business requirements, and subject expertise.

· Critical review of pre-publication artifacts.

· Bridging relevant industry work with VA internal efforts (e.g., Interoperable VA (iVA) Blueprint*).

*The Interoperable VA (iVA) Blueprint identifies relevant HIT standards, put into context of a referenceable solution architecture to provide informative guidance to VHA, OIT, Program Offices, non-VA clinical and business stakeholders. This will allow VHA to more effectively support projects and acquisitions in support of business interoperability needs in part by identifying which standards need to be used under what circumstances and providing clear and actionable guidance for project teams. This effort allows identified gaps within the industry standards portfolio to be risk mitigated, improving VA’s interoperability posture both internally and with external care partners.

The Contractor shall review, enhance, update, and revise the Interoperable VA (iVA) Blueprint to maintain currency of that artifact with best industry practices and emerging standards work. This includes provision of subject expertise to VA working groups, facilitation of enhancement activities, development of architectural diagrams or standards implementation guidance, critical review and independent assessment of guidance provided, and comparative analysis between VHA and related industry efforts.

Defined Deliverables:

A. Strategy Working Group Ongoing Engagement B. VHA Interoperability Architecture

Undefined Deliverables: The deliverables will be described within each TO. The quantity and detail of the deliverables will depend on the scope of the specific task order and might include items such as recommendation assessments, decision briefs, strategic plans, implementation/adoption plans, and artifact analysis.

5.4 VA Standards Advancement and Adoption

The Contractor shall engage with VA project teams to advance the utilization of and compliance with identified standards guidance, with the objective of improving VAs interoperability posture within and outside of the agency. The teams shall interpret existing VA standards guidance, such as the VA Enterprise Architecture, the Technical Reference Model (TRM), the Interoperable VA (iVA) Blueprint, and other government-furnished information (GFI) documents, assisting project teams in making informed design and implementation decisions. Note that this includes interoperability pertaining to EHRs, clinical systems, administrative systems, medical devices, and clinical knowledge.

As requested, the team shall conduct independent assessment of project work as relating to standards usage and make recommendations to allow projects to better align with and utilize health interoperability standards. The Contractor shall maintain a log of project engagements and recommendations, documenting both positive and problematic implementation patterns for use in refining VA guidance.

Project team support will be stratified into two types of engagement: ongoing and tactical. Ongoing engagement will involve routine active participation in project activities, including but not limited to attendance on working calls, monthly design reviews, and document reviews. Tactical engagement will involve a short-term involvement with the project team, generally the form of attendance at key design or document reviews, and a resultant recommendation document. For example, KBS may be identified to provide sustained standards support to the Office of the EHR Modernization Program (OEHRM) on an ongoing basis. This would likely include providing applied FHIR expertise, interoperability strategy support, requirements support, and standards configuration guidance. Alternatively, KBS could be asked to provide a “standards consult” to review a specific implementation design and provide informed feedback, for example with FHIR financial standards guidance to X12 mappings.

The current industry trend favors under-specification within a core standard, and then identifying enhancement or extension mechanisms to allow for implementing organizations to address additional constraints not addressed within the base specification. As a result, to achieve interoperability necessitates the adoption of “standards profiles” which broaden the scope of the standard to address additional scope items needed for interoperability. For the purposes of a common reference, these shall be designated VA-Configured Standards Artifacts.

Working with Government personnel, the Contractor shall identify a prioritized list of candidates where either a VA standards profile or a VA-specific implementation guide is required or warranted. Recommendations will be reviewed by the Government, prioritized, and selections made for execution. Each selection will be developed in two stages: an interim and final artifact, thus providing mechanisms to support iterative enhancement and government feedback on the work.

Additionally, there is significant value in assisting S&I, KBS, and CIDMO at large with the awareness of the subject matter expertise that this office can provide to projects across the department. The Contractor shall support strategic communications and intra-agency outreach efforts that may arise from a number of sources. The Contractor shall also provide recommendations on things such as the identification of projects for which to engage, a strategic approach to project engagement, and assistance with “marketing” the standards expertise that this office can provide.

Defined Deliverables:

A. VA Projects Standards Adoption Ongoing Engagement B. VA Projects Standards Adoption Tactical Engagements

Undefined Deliverables: The deliverables will be described within each TO. The quantity and detail of the deliverables will depend on the scope of the specific task order and might include items such as VA project standards and interoperability assessments, recommendation reports, interoperability checklist creation, strategic communications support.

6.0 GENERAL REQUIREMENTS

6.1 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 Technical Functional Areas 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 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 the submitted proposal.

6.1.2 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 three (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 one (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 five (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 three (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 three (3) business days that documents were signed via e-QIP).

1. The Contractor…