Attachment_2_-_IDIQ_SOO_-_Appendix_E.pdf

PRE-DECISIONAL - INTERNAL

Indian Health Service

HEALTH INFORMATION TECHNOLOGY

MODERNIZATION PROGRAM

RFP No. 140D0421R0050 Appendix E: HIT Modernization

Program Management Plan (PMP) (Preliminary) v2.1

January 31, 2021

Submitted By:

CMS Alliance to Modernize Healthcare

Federally Funded Research and Development Center (Health FFRDC) ihs-modernization@mitre.org mailto:ihs-modernization@mitre.org

Program Management Plan

IHS HIT Modernizat ion Program 2

Table of Contents

1. Introduction

1.1 Background

2. Scope

3. Roles and Responsibilities

4. Program Management Approach

4.1 IHS Enterprise Performance Lifecycle

5. Risk Management

6. Schedule Management

6.1 Integrated Master Schedule

7. Change Management

7.1 Change Management Authority

8. Financial Management

9. Document and Knowledge Management

10. Quality Management

11. Performance Management

12. Systems Engineering Management

12.1 Engineering Resources and Management

12.1.1 Government Technical Organization

12.1.2 Relationships with External Technical Organization

12.2 Program Technical Requirements

12.2.1 Architecture Control

12.2.2 Interfaces

12.2.3 Interface Management

12.2.4 Data Management

12.2.5 Data Management Strategy

12.3 Technical Activities and Products

12.3.1 Planned SE Activities

12.3.2 Requirements Management

12.3.3 Systems Engineering Technical Reviews

12.3.4 Technical Baselines and Audits

12.3.5 Supportability

12.3.6 Design Considerations

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12.3.7 Engineering Tools

12.4 Cybersecurity and Privacy

12.5 Net Readiness Performance

13. Project Execution Management

14. Definitions, Acronyms, and Abbreviations

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List of Figures Figure 1. HIT Modernization Notional Governance Structure Figure 2. PMO Approach to Integrate Program Management Processes Figure 3. Risk Management Process Figure 4. Schedule Management Components and Process Summary Figure 5. PMO Financial Management Plan Context and Scope Figure 6. Example Lifecycle of a HIT Modernization Program Document Figure 7. SE IPT Structure Figure 8. Requirements Management Process Figure 9. IS EPLC Lifecycle Framework

List of Tables

Table 1. List of Key PMO Operations Staff Table 2. Risk Plan and Register Key Features Table 3. Planned IHS HIT Modernization SE Activities Table 4. IHS HIT MOD Technical Review Matrix Table 5. Engineering Tools Table 6. EPLC Tailoring for HIT Modernization Program Table 7. Acronyms

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1. Introduction This Program Management Plan (PMP) provides an overview of the Indian Health Service (IHS) Division of Health Information Technology Modernization and Operations (DHITMO) will operate as the program management office (PMO) that will support the Health Information Technology (HIT) Modernization Program (“the Program”). The PMP discusses the background, business need, scope, roles, and programmatic approach of the Program. This document summarizes general and applicable guidance on program management, execution, authority, and integration. The PMP outlines flexible procedures and methods that will meet the ongoing demands of the Program. The HIT Modernization selected vendor will be required to comply with and participate in all processes presented in this document to ensure efficient operation of the PMO.

Detailed management plans for each process will be provided separately upon award of the IDIQ contract.

This Program is a multi-year overarching plan to modernize HIT systems and processes and offer corporate services across IHS, Tribal, and Urban (I/T/U) healthcare facilities to promote excellence and quality throughout the Indian healthcare system. The program management processes leverage industry best practices for planning, schedule, financials, risk, communications, and requirements and knowledge management, as well as innovative technology and experienced personnel to meet IHS HIT Modernization Program performance objectives. The HIT Modernization Program will also work to provide opportunities to recognize and respect tribal sovereignty through meaningful tribal consultation and conferring with Urban Indian Organizations (UIOs).

1.1 Background

IHS is the principal federal healthcare provider and health advocate for American Indian and Alaska Native (AI/AN) people. IHS provides a comprehensive health services delivery system for AI/AN beneficiaries through a network of hospitals and healthcare facilities. The range of services includes, but it is not limited to, traditional inpatient, ambulatory care, preventive care, and public health.

The vision of this program is to support the IHS mission to raise the physical, mental, social, and spiritual health of AI/AN people to the highest level. IHS currently uses an in-house application suite, the Resource and Patient Management System (RPMS), that relies on core modules of the Department of Veteran Affairs’ (VA) system, VistA, to support various clinical and administrative operations to provide health services to AI/AN people. IHS will leverage knowledge from the VA’s modernization efforts, as well as experience from Tribes and UIOs that have already modernized, to accelerate next steps for the HIT Modernization Program.

Similar efforts at other federal agencies or I/T/U facilities will inform the Program of the capabilities available in the marketplace, the complexity of Electronic Health Record (EHR) implementation, federal interoperability requirements, recommended phasing approaches, and impact on clinicians, patients, and providers.

IHS, in collaboration with the Department of Health and Human Services (HHS) Office of the Chief Technology Officer, completed the first step of a multi-faceted approach to

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HIT modernization by evaluating the current state across I/T/Us and identified alternatives to aid in future HIT modernization and decisions. The Program must apply lessons learned from complex HIT modernization efforts to address the potential, and likely, challenges, which include:

• Meeting the requirements of a diverse set of partners and stakeholders with differing financial and management relationships to IHS

• Adapting to the tribal shares model, which can cause fluctuations in the targeted facilities

• Complying with federal, state, and tribal reporting requirements

• Configuring and scaling solutions to provide the needed capabilities and workflows to meet the requirements of facilities of different sizes and services

• Addressing the disparate technological capacity within Indian Country

• Respecting tribal sovereignty while encouraging a centralized approach

• Migrating and synchronizing data across different platforms throughout a phased implementation

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2. Scope The scope of the Program Management Plan includes all functions of the DHITMO that require participation by and adherence to by each project and vendor that is included in the program to ensure effective program administration.

All projects, IHS staff, and contractors aligned with the Program will require strong management discipline throughout the program lifecycle to keep the Program on schedule and within budget, as well as to mitigate and manage risk.

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3. Roles and Responsibilities Table 1 contains a list of key PMO Project Operations resources for the DHITMO and a high-level summary of their responsibilities to the Program.

The four resources and described responsibilities listed in Table 1 align with and execute the essential PMO Project Operation functions – Project Administration, Project Management and Governance. Essential Project Operations functions will include supporting material and services provision, providing financial oversight, supervising document and knowledge management, conducting dashboard and report management, and coordinating EPLC artifacts. Full detail on DHITMO organization design and organization function will be provided separately upon award to the modernization IDIQ vendor.

Table 1. List of Key PMO Operations Staff

Resource Role/Responsibility/Area of Expertise PMO Operations Senior Program Manager

• Ensures provisioning of support material and services, the quality of these services delivered, provides strategic management, promotes open communication and collaboration with other components within the HIT Modernization Program, and provide financial oversight in compliance with the budgetary formulation for the Program.

• Oversees all Project Administration, Project Management and Governance functions of the PMO.

• Provides strategic recommendations and direction on health-related acquisition programs

• Responsible for:

o Considering issues of shared governance with other councils o Interfacing with a Technical Advisory panel external to the HIT Modernization program o Document and Knowledge Management o Reporting and Dashboard o EPLC Artifact Coordination o Audit Support o Meeting Management o Resource Management o Risk Management o Schedule Management o Process Development o Change Management o Governance operational support

Program Administration Manager

• Performs management, collaboration, development, and successful solution delivery in several key areas required for the effective administration of the HIT Modernization Program.

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• Responsible for:

o Document Management o Knowledge Management and Tools o EPLC Management o Meeting Management o Resource Management o Working closely with Integration lead on coordination of working group and workflow activities with CMIO Functional organization outside PMO o Collaborating with other functional integration roles in other PMO pillars such as Requirements Manager, Functional SME Integrator, and Functional SME coordinator

Governance Manager • Provides the structure for, and orchestrates the process required for, facilitating decision making and the escalation of risks, issues, and changes to Program scope, cost, and schedule

• Responsible for:

o Implementing operational decisions o Supporting the Healthcare Delivery Council by standardizing workflows across facilities and providing input to the PMO to guide implementation of workflows in coordination with the vendor o Facilitating and leading Governance board and executive oversight teams o Create and facilitate Governance process o Content preparation, meeting material distribution, records management, action item tracking, and meeting management

Project Management Specialist

• Implements the processes required for proven project management practice across the HIT Modernization Program

• Responsible for:

o Implementing a risk management process and ensuring that the process is followed across the program o Reviewing identified risks and validating that they are adequately prioritized and mitigated o Integrated Master Schedule management o Reviewing and tracking contractor generated schedules identifying and mitigating schedule related risks and issues o Receiving and reviewing contractor generated status reports o Providing program status to program leadership o Developing project management practice o Performance management

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Figure 1 depicts where the DHITMO as the PMO fits within the IHS HIT Modernization Program governance structure, to whom the DHITMO is accountable, and how the DHITMO will interact with tribal partners and external partners across the Program.

Figure 11. HIT Modernization Notional Governance Structure

The HIT Modernization governance structure is evolutionary and phased in three major steps.

The first step, the Federal Accountability consists of the HIT Modernization Executive Steering Committee (ESC) and DHITMO. The second phase engages through consultation and conferring with I/T/U as the Partnership to Guide HIT Modernization. This will consist of three focus groups, Interoperability, Data & Analysis, and Implementation.

The Interoperability Group is responsible for reviewing and suggesting strategies, operational requirements, clinical practice standards, and performance measures that inform the interoperability solution design and project planning. The Data & Analysis Group is responsible for reviewing and suggesting strategies that support effective data use, security and privacy controls, and standards. The Implementation Advisory Group is responsible for helping the ESC understand the strategies used by other Federal agencies, Tribes, and Urban Indian Organizations to modernize their Health IT capabilities and resulting performance changes in health care delivery. Input from this group will inform decisions regarding implementation planning and organizational readiness.

The final step in the governance model is to establish the Enterprise Management Group (EMG). The role of the EMG will promote and support the goals and objectives of the Federal Accountability and to address and monitor outcomes, challenges, new features, patches, timelines, etc. This group will leverage their strength and experiences to inform decisions.

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4. Program Management Approach The DHITMO collaborative program management approach, illustrated in Figure 2, is a tool to manage all aspects of the program and includes multiple checkpoints and formal and informal communications that create high visibility of project performance to the IHS leadership and the project team1.Moreover, the program will adhere to the Enterprise Performance Life Cycle (EPLC) framework set forth for IT projects as well as the Capital Planning and Investment Control (CPIC) approach for managing and tracking IT investments. The EPLC framework may be tailored to align with program-specific needs and more intuitive review cycles for the various modernization projects but will adhere to the same or greater level of requirements for EPLC gate reviews. Additional information on the Program’s use of the EPLC framework can be found in Section 4.1 of this Plan and the EPLC Business Process Agreement. Additional information on CPIC approach and processes can be found in the Financial Management Plan which will be provided upon award to the modernization IDIQ vendor.

Figure 22. DHITMO Approach to Integrate Program Management Processes

Key highlights of the HIT Modernization Program approach, as managed by the DHITMO, include:

1 The HIT Program utilizes the Program Management Approach – founded in project management best practices and principles from the Project Management Body of Knowledge (PMBOK) and Informational Technology Infrastructure Library (ITIL) – as a tool to manage all aspects of the IHS HIT Modernization Program.

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• Capturing critical project activities, milestones, timeframes, dependencies, and resources in an Integrated Master Schedule (IMS)

• Maintaining a Risk Register with mitigation steps, probabilities of occurrence, impact ratings, and assigned owners

• Establishing a communication cadence for reporting progress and issues

• Creating an ongoing framework to facilitate decision-making, and clarify and resolve issues

• Establishing strict quality control procedures and feedback mechanisms

• Control and oversee organizational change management processes

• Lead and conduct project reviews of status and metrics, as well as enforce standards and processes

• Facilitate access to relevant documents and knowledge across Program efforts

The IHS HIT Program Management approach includes clearly defining detailed plans and procedures for program financial management, schedule management, risk management, quality management, change management, document and knowledge management, and communications management. The initial stand-up of the DHITMO will be particularly important to ongoing IHS HIT Modernization implementations. The DHITMO’s technical and functional expertise, as well as agile methodology, will facilitate ongoing and future HIT implementations.

The DHITMO will approach projects independently and objectively to conduct program management and align program resources to achieve the HIT modernization goals and objectives. The DHITMO will also incorporate change management and Human- Centered Design principles into tasks and projects to improve the user and partner experience throughout the HIT Modernization Program efforts and beyond.

4.1 IHS Enterprise Performance Lifecycle

The DHITMO will follow a tailored EPLC framework that fulfills IHS IT investment requirements and aligns gate reviews to meet the needs and requirements of the Program and its projects. The EPLC framework provides a project management methodology that guides the activities of Investment Managers, Project Managers, Business Sponsors, Critical Partners, the various IT governance organizations, and other partners throughout the lifecycle of the Program to ensure an enterprise perspective is maintained. The IHS EPLC framework ensures alignment with HHS goals, objectives, and procedures for programmatic efforts as well as establishes an environment where IHS HIT projects are better positioned to achieve successful outcomes. Each HIT Modernization project will leverage and meld the EPLC and Agile methods to best meet project-specific needs. Section 13 of the PMP (Project Execution) will provide more detail on program and project tailoring of the EPLC framework.

5. Risk Management The IHS HIT Risk Management approach requires that all organizations participating in the HIT Modernization Program use a common and centrally managed process. The

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HIT Modernization Risk Management Plan, which will be provided separately upon contract award, defines the detailed procedures that have been developed to implement the IHS Healthcare IT directive for risk management. All projects and vendors assigned to the IHS HIT Modernization Program are expected to manage and monitor project related risks. The DHITMO provides guidance and an exemplar of the risk register used to manage risks at the project level, however, projects are allowed the discretion to modify their respective registers to meet the needs of their project management.

Projects will be required to escalate risks that meet criteria for program-level impact to the DHITMO. The DHITMO will be responsible for managing and reporting program-level risks to IHS leadership, with input from the project’s risk owner.

The Risk Management Plan (provided separately upon contract award) addresses risks, issues, and action item management as they apply to the IHS HIT Modernization Program. The DHITMO owns the responsibility of managing the overarching risk management processes and provides evaluations and assessments, regarding the identification, analysis, mitigation, and reporting as described in Figure 3.

Figure 3. Risk Management Process

The IHS HIT Modernization Program ESC will act as a decision-making body DHITMO to address, adjudicate, and disposition risks, as well as assign risk owners. The DHITMO will work tactically and strategically with the ESC to ensure only appropriate risks are elevated to the ESC and any actions dictated by the ESC are implemented throughout the Program. In addition to collaboration with the ESC, functional impact analysis of risks and risk mitigation plans, particularly those related to design, workflow, or change management, will require DHITMO coordination with the CMIO.

The table below summarizes the key features of the Risk Management Plan (provided separately upon contract award) and Risk Register:

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Table 2. Risk Plan and Register Key Features

Role Description Risk Management Planning Determine how to approach, plan, and execute the risk management activities for the Program.

Risk Identification Determine which risks might affect the Program and document their characteristics.

Risk Analysis Prioritize risks for subsequent further analysis or action, by assessing and combining their probability of occurrence and impact.

Risk Response Planning Develop options and actions to enhance opportunities and reduce threats to Program objectives.

Risk Monitoring and Control Perform risk assessments and develop priorities and actions based on the assessed impact to Program services.

Additional details regarding Risk Management plans and processes are documented in the IHS HIT Modernization Risk Management Plan, which will be provided upon award to the modernization IDIQ vendor.

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6. Schedule Management The Schedule Management Plan outlines the methodology the DHITMO will leverage to establish, monitor, and implement the Program’s schedule artifacts. The DHITMO will utilize a hybrid approach to managing schedules, which defines Program-wide standards and expectations and then allowing Project Teams to provide the required, relevant information for inclusion in the Integrated Master Schedule (IMS). This approach involves an iterative and continuous integration throughout the Program lifecycle in order to adapt quickly to changes in requirements and have flexibility in meeting all project needs. Figure 5 outlines the major activities associated with schedule management.

The Schedule Management Plan provides an outline for planning, scheduling, and integrating the Program schedule. The DHITMO will maintain oversight across project schedules and will require reporting of key milestones and mission-critical dates.

Beyond requiring IMS data elements and tracking critical program-level tasks, the DHITMO will not manage individual project schedules and the detailed tasks and activities they may be tracking. The DHITMO will have the authority to invoke schedule management and review over individual projects, particularly to ensure they are up to date and abiding by other related program management requirements, such as change control. The DHITMO will identify, track, and communicate risks and dependencies among the individual projects to maintain a holistic understanding of Program IMS and streamline schedule management activities. Project schedules, milestones, and dependencies support the Program’s development of a baseline for tracking actual progress, the resources used, and percentage complete. The schedule evaluation criteria will provide periodic and transparent progress across all tasks and deliverables throughout the lifecycle. Future projects will complete schedule evaluation criteria to monitor and track details of individual project schedules including key milestones and major deliverables.

Additional details regarding schedule management processes and procedures are available in the Schedule Management Plan, which will be provided separately upon award to the modernization IDIQ vendor.

6.1 Integrated Master Schedule

The DHITMO will be responsible for managing the schedule of the IHS HIT Modernization Program. The schedule for project activities follows the cadence of, and is dependent on, the IMS. A draft of the IMS and template will be provided upon award and the DHITMO will work with the vendor to develop a baseline schedule during the first 90 days of the contract.

The DHITMO will perform the following functions:

• Set required schedule metrics for project teams to report to the DHITMO (ex.

start/finish duration, % complete, project area, etc.)

• Monitor and gather information on activities, tasks, and milestones defined in the

IMS

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• Monitor the IMS to review adherence to best practices as well as progress, slippage, and other issues associated with the schedule

• Report on schedule adherence in periodic status meetings or team meetings

• Track the critical path project-level planned dates versus the actual dates for completion

• Track the critical path based on project-level planned dates versus the actual dates for completion

• Present a get-well plan that gets projects in the Program back on schedule

• Present the IMS so that the entire Program is aware of tasks that fall on the critical path

• Summarize and report the IMS in a collapsible and referenceable visualization

• Monitor and update the IMS in Planview throughout the entire Program lifecycle

• Oversee the establishment and integration of current and future projects’ schedules

Figure 4. Schedule Management Components and Process Summary

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7. Change Management The DHITMO Change Management Process targets the following objectives:

• Provide a consistent approach for identification, documentation, communication, and management of project changes

• Establish escalation criteria for change requests

• Ensure that changes are evaluated for impact on projects and on related or interdependent projects

• Facilitate the evaluation of changes at the appropriate level

• Provide traceability of a change request through evaluation, approval/ disapproval, and implementation

• Enable the orderly implementation of approved change requests

Baseline change control to be performed by the DHITMO includes:

• Overseeing the process for modifying baselines associated within the Program and with projects

• Identifying required changes that would otherwise not be identified by project teams or IHS leadership

• Establishing criteria for, reviewing, and escalating change requests

• Collaborating with vendors to include recommendations for change request solutions

• Managing changes including those requiring escalation beyond the DHITMO

Director

• Involving the CMIO and SME feedback on functional, technical, operational processes related to change management

• Facilitating implementation of approved changes

• Managing resolution of unapproved changes

• Updating Program documentation following change approval and implementation

Effective change management processes will require input from all projects and vendors, as well as appropriate escalation processes with the Integrated Project Teams (IPTs), the PMO Director, and/or ESC. The standard function and concept of a Change Control Board will be performed by the ESC. Along with the PMO Director and ESC, the CMIO and other relevant technical SMEs will serve in a change management advisory role and have input on processes, efforts, and approvals. All program changes will require formal approval, but not all program changes will require approval from the ESC.

Either the PMO Director or ESC will review change requests, ensure that they are compatible with mission objectives, approve or deny the change requests, and align them with the current state of the Program. For changes brought to the ESC, the DHITMO will continuously coordinate with the ESC to ensure change requests

IHS HIT Modernizat ion Program 18 presented to them are standard and appropriate and will ensure decisions and intended outcomes are carried out in the project teams.

If approved, changes related to Program baselines (scope, schedule, cost, etc.) will require continual coordination and management, particularly for all related changes to work efforts, contractor management, financing, and technical systems. The following are key considerations when managing change related to Program logistics and systems:

• Changes to the scope of the Program must align with the IHS mission.

• Most scope and technical requirements changes will impact project cost and schedule.

• Configuration changes to engineering-specific products will invoke DHITMO involvement and Program change management processes only when the change has impacts that go beyond the localized project.

7.1 Change Management Authority

Project change management and authority will occur at multiple levels across all projects. The following roles take on varying levels of responsibility and authority over change management.

Project Manager The Project Manager (PM) serves as Change Manager for assigned projects and is responsible for reviewing all change requests with the project team during weekly project status meetings. For some large projects, the PM may establish and facilitate a project-level IPT, which performs initial review of all change requests and is authorized to approve change requests below certain thresholds. IPTs may consult with the CMIO team for SME input on relevant change management processes. The PM may also be responsible for updating project information in the assigned change management tracking tool after the change request is approved, as outlined in the Change Management Plan, which will be provided separately upon award to the modernization IDIQ vendor.

PMO Operations Senior Program Manager The PMO Operations Senior Program Manager serves as the next level change control authority and is responsible for chairing the Program IPT and for reviewing change requests escalated to the Program IPT level. The PMO Operations Senior Program Manager will also support the PMO Director in review, approval, and escalation of change requests to the ESC.

PMO Director The PMO Director is the last level of change control authority before the ESC. They work with PMO Operations Senior Program Manager to review Program level change requests and will either act as an approval authority or further escalate to the ESC.

Additionally, the PMO Director will consult with the CMIO and apply their expertise into

IHS HIT Modernizat ion Program 19 change management processes. The PMO Director is the main link between the Program and ESC in change control processes.

Executive Steering Committee (ESC) The ESC will serve as the Change Control Board through review of change requests that exceed the Program-level IPT’s authority to approve. Where necessary, the ESC may further escalate a change request that may impact on organizational entities other than the IHS HIT Modernization Project or may involve other entities in collaborative decision-making. Change requests for all projects submitted to the DHITMO must be approved by the ESC. Others may be subject to higher level review/approval through the ESC via the PMO governance process. Once the ESC has approved a change request for an IHS HIT Modernization project, the approved change request will be submitted to the PMO Director via the ESC. No changes to an IHS HIT Modernization project can be made until the ESC has officially approved the change request. The change request will remain open until all decisions are confirmed.

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8. Financial Management The HIT Modernization Financial Management Plan, which will be provided separately once the modernization IDIQ contract is awarded, details the required processes to effectively plan, execute, monitor, control, report, and evaluate budgets and costs for the HIT Modernization Program and underlying projects within this investment. Projects teams will be required to provide their detailed cost estimates so IHS and DHITMO can ensure adequate funding is available for project execution. Upon funding approval, the project teams will be required to report monthly on financial performance, providing monthly reports of Planned versus Actuals. This includes providing monthly budget and cost data to the CPIC manager at IHS for external reporting to HHS and the Office of Management and Budget (OMB).

The Financial Management Plan (provided separately upon contract award) highlights the processes of developing Life Cycle Cost Estimates (LCCEs); leveraging the Technology Business Management Taxonomy to standardize financial reporting;

submitting Annual Funding Requests (AFR’s); baselining the budget and spend plan;

and monitoring and controlling financials through internal reporting to IHS leadership and external reporting per the CPIC guidance.

LCCE’s will serve as inputs into AFRs that are processed and approved in IHS’s budget formulation tool, Planview. The approved AFR’s will serve as the Financial Baseline and budget for project execution. Effective program financial management will commence with monthly financial reporting that includes budget versus actuals, variance analysis, and corrective actions as needed. Figure 5 below depicts the context and scope of this plan, which will be provided separately upon award to the modernization IDIQ vendor.

Figure 5. PMO Financial Management Plan Context and Scope

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Detailed processes and procedures for the DHITMO Financial processes are outlined in the Financial Management Plan, which will be provided separately upon award to the modernization IDIQ vendor.

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9. Document and Knowledge Management The Document and Knowledge Management (DKM) Plan provides a framework to capture, transfer, and disseminate program documents and knowledge throughout the maturation of the IHS HIT Modernization Program. The DKM Plan describes the purpose of document and knowledge management, tools and processes used to facilitate program document and knowledge management across the DHITMO and project teams. All projects and vendors will be required to comply with all document and knowledge management requirements for the program. Figure 6 provides the logic flow associated with the lifecycle of a HIT Modernization Program document.

Figure 6. Example Lifecycle of a HIT Modernization Program Document

The purpose of knowledge management is to increase access to and standardize the definition, identification, capture, management and communication of Program information and resources. The objective of knowledge management for the HIT Modernization Program is to standardize the approach to sharing information within and across the Program to ensure all relevant parties have access to the documents and knowledge required to make informed decisions and successfully fulfill their responsibilities.

The IHS HIT Modernization Document and Knowledge Management Plan (provided separately upon contract award) will discuss the following:

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• Roles and responsibilities of IHS leadership, the DHITMO, and other project teams in the document and knowledge management process

• Types and sources of knowledge, such as source material, business cases, charters, deliverables, templates, meeting minutes, key decisions and lessons learned

• Tools to facilitate document and knowledge management

• Methods and processes to effectively manage documents and knowledge

• Processes to facilitate knowledge capture, transfer, and management

Additional details regarding tools and processes of document and knowledge management can be found in the Document and Knowledge Management Plan, which will be provided separately upon award to the modernization IDIQ vendor.

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10. Quality Management The Quality Management Plan, which will be provided separately upon modernization IDIQ contract award, sets forth procedures and guidelines that IHS will use in evaluating the technical performance of the HIT Modernization Program. The surveillance methods identified in the Quality Management Plan, in conjunction with the DHITMO’s quality assurance procedures, will ensure quality performance by the Program’s projects and project teams.

The Quality Management Plan will outline the following:

• Define the roles and responsibilities of the DHITMO and other Program teams in the quality assurance process

• Define the types of work performed with their respective results requirements, contractual objectives, and deliverables to be completed

• Document the required performance measurements and metrics

• Describe the evaluation methods that will assess performance

• Describe the process by which performance will be documented under this

Quality Management Plan The Quality Management Plan will be a tool for the lifecycle of the HIT Modernization Program and remains subject to revisions at any time. The DHITMO will be responsible for management and quality control actions to meet the needs of the Program. Projects and vendors within the Program will participate in the quality management processes as needed.

The Quality Management approach is based on the strict quality and independence standards for federal agencies, as well as on best practices promulgated by PMI’s PMBOK. The Quality Management Plan establishes integrated quality processes at both the program and project levels to monitor overall program, contract, and project performance and technical quality. The Quality Management Plan details procedures to identify and remediate product and service deficiencies; make sure that services are performed in an accurate, complete, and timely fashion; and affirm that work products comply with contract requirements and performance metrics. At the project level, teams execute quality processes that focus on monitoring and reporting performance and quality across each task. At the task level, project teams execute a quality process based on three fundamental pillars—quality planning, quality assurance, and quality control and reporting—designed to elicit client input early and incorporate multiple reviews that enable teams across the program to deliver IHS high quality deliverables and solutions.

Quality Planning. The DHITMO identifies relevant quality standards and determines how projects can satisfy them. The DHITMO performs quality planning while developing this Program Management Plan and the Integrated Master Schedule so that quality-related cost and schedule adjustments are considered. Quality planning outputs include the Quality Assurance Plan, metrics, and checklists

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Quality Assurance. The DHITMO applies planned, systematic quality activities and testing to each project within the HIT Modernization Program to make certain that project results comply with requirements and standards (e.g., project goals). Continuous improvement is a critical element. Quality Assurance outputs include corrective action recommendations and work product defect and problem reports.

Quality Control (QC) and Reporting. The DHITMO monitors project results to validate compliance with requirements and quality standards and to eliminate causes of unsatisfactory performance. QC activities provide prevention (e.g., keeping errors out of processes) and inspection (e.g., keeping errors out of IHS).

The DHITMO approach to Quality Assurance focuses on rigorous review processes executed at the program level and integrated into robust monitoring and reporting processes at the project level.

Additional details regarding quality management processes and procedures are available in the Quality Management Plan which will be provided separately upon award to the modernization IDIQ vendor.

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11. Performance Management An iterative and evolutionary process, performance management is a core component of overall program and project management. As a management tool, Performance Management provides a structured approach to identify and evaluate progress, instill accountability, and build an archive of performance data for comparison, analysis, forecasting, and decision making. Performance Management as a strategic process is used to assess accomplishment of organizational strategic goals and objectives.

The primary output of performance management is reliable information and key performance indicators upon which decisions can be made, potential problems and risks can be detected and mitigated, incentive for desired results can be built, and an archive of past performance for future assessment and planning can be developed.

Basic performance management questions include:

• What has happened?

• Why has it happened?

• Is it going to continue?

• What, if anything, needs to be done? (Generally, in response to a high-level understanding of how the event happened.)

The answers to these questions are conveyed through the analysis of measures harvested either as by-products of routine work cycles or obtained from sources providing input to the process being measured or using the products of the process that is being measured. For example, because of the success of a deployment of a new EHR solution, a health care provider may be able to provide better insight and service to Indian Health Service facility patients. If data such as dates and location are added to the input, it would be possible to assess the effectiveness of solution deployment or efforts.

While Performance Management tells a story, it provides the means to monitor results towards a defined end state, redirect activities that are at risk of missing targets, discern unanticipated benefits and trends, and build an archive for future comparison and planning.

Additional details, processes, procedures, and KPI’s are outlined in the IHS HIT Modernization Performance Management Plan, which will be provided separately upon award to the modernization IDIQ vendor.

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12. Systems Engineering Management The IHS HIT Modernization systems engineering processes were developed to meet applicable statutory and regulatory requirements across the HIT System of Systems (SoS) acquisition lifecycle outlined in the IHS HIT Modernization Acquisition Strategy2.

This section documents the systems engineering approach, technical processes, reviews, planned technical activities and associated timelines needed to implement a Commercial off the Shelf (COTS) solution. These processes will be used by Government staff and contractors and/or vendors to align activities to address the statutory and regulatory requirements for meeting key acquisition milestones and deliverables.

12.1 Engineering Resources and Management

This section discusses how Systems Engineering is aligned within the DHITMO. It also gives a brief description of Engineering’s role in the successful implementation of the HIT Modernization Program.

12.1.1 Government Technical Organization

The government technical organization is made up of two components, the DHITMO and Systems Engineering (SE) IPT. Government resources will manage each of these components and will align with vendor and/or contractor to support the IHS HIT Modernization Program.

SE is a critical part of the IHS HIT Modernization Program and will align with the Program’s mission and goals to ensure success. The SE IPTs will help to ensure proper integration with the IMS, Risk Management processes, and support of the IHS HIT Modernization program milestones. Some of the IPTs includes, but is not limited to:

• SE IPT

• Data Management Council

• Cyber Security Working Group

• Interface Control Working Group

• System Technical Requirements Working Group

Additional information will be provided to the vendors once they have been selected and the implementation begins.

The IHS HIT Modernization engineering efforts will leverage a SE IPT construct with multiple task-focused Working Groups (WGs) to complete specific implementation tasks. WGs may be organized on an ad hoc basis and will focus on specific elements of the program efforts from a post contract award perspective. The WG efforts will be integrated and managed by the SE IPT. As issues are identified, the work will be allocated to the appropriate WGs to help identify a solution. DHITMO representatives, Contractor/Vendor(s), and relevant external stakeholders will participate in WGs as

2 For the purpose of this implementation, the SoS is defined as a collection of systems, each capable of independent operation, that interoperate together to achieve additional desired capabilities.

IHS HIT Modernizat ion Program 28 appropriate. The current SE WGs are listed below in Figure 7. WGs may change throughout the implementation process based on program needs.

Figure 7. SE IPT Structure

12.1.2 Relationships with External Technical Organization

The DHITMO will interface with various IHS technical organizations throughout the duration of the program on an as needed basis. The DHITMO will also interface with external vendors throughout the implementation to ensure Program success.

12.2 Program Technical Requirements

This section describes how Engineering will manage implementation architecture and interface control of the HIT Modernization Program. Engineering will fall within the DHITMO and be responsible for all aspects of the technical requirements for the program.

12.2.1 Architecture Control

A clearly defined architecture development strategy will improve the ability of the DHITMO to make key decisions more effectively through organized information sharing across program boundaries. The DHITMO will employ industry best practices and guidelines to manage and produce architectural artifacts as well as leverage existing IHS architecture artifacts for maximum efficiency. This will be accomplished during the development of architecture products in support of the HIT implementation and general HIT Modernization. All artifacts will be maintained according to IHS HIT Modernization Change Control Management and Architecture Management processes.

The IHS HIT Modernization Enterprise Architecture models the HIT System of Systems and related HIT components within the IHS enterprise as well as the business and technical activities that have critical dependencies on enterprise architecture. All architectural activities will focus on the deliverables, dependencies, and resources required to address the targeted mission outcomes.

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12.2.2 Interfaces

The expectation is that Systems Engineering will strategize to minimize the building of custom interfaces by leveraging existing industry standards-based interfaces and libraries provided by the new EHR vendor. Interfaces using common standard ontologies, data formats and data models will help ensure that data exchanged will be interoperable across the HIT Modernization program and with other external systems.

To minimize disruption of data flow between current external systems and the new HIT System of Systems, it is expected that some existing IHS interfaces with legacy clinical and business systems will be analyzed and leveraged (on a case-by-case basis).

Where possible, commercial standards such as HL7 2.x, DICOMix, and FHIRx should be used to promote interoperability.

12.2.3 Interface Management

Detailed work analysis and refinement of interface requirements and specifications will begin once the IDIQ contract is awarded. Initially, interface development will focus on the interface requirements in the Requirements Traceability Matrix. A series of technical meetings will be scheduled with each of the external system owners to gather data exchange needs, formats, and transfer mechanism. The awarded contractor is expected to use the data gathered from these meetings to draft each interface using the modeling approach and submit as deliverables to DHITMO for review, feedback, and correction.

Additionally, interfaces requested by the functional and business SMEs/councils will adhere to the defined Program’s Governance process as well as an analysis by the Interface Working Group (see Governance and Working Groups). Each request will be carefully considered for its necessity in supporting IHS’s strategy of minimizing the number of interfaces. Change requests for interfaces will go through the Change Management process that has been put in place by the IHS HIT Modernization Program.

12.2.4 Data Management

The HIT System of Systems will conduct data management for all its stakeholders, the tribal partner community, and develop options for the HIT Modernization Program as well as retrieve relevant data for both internal application and external access. The HIT Modernization Data Management Strategy and Requirements V1.0 describes the strategy and defines the approach for creating, managing, and delivering data across the program. These requirements will be communicated with the selected vendor during the implementation phase. Data will be accessible across different domains to enhance the financial, operational, and analytic capabilities of the enterprise.

The full value of data and information resources will be realized when the HIT Modernization Program can appropriately share data and information internally, as well as with external partners. The selected Contractor is expected to provide the execution plans to support the data strategies of the enterprise.

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12.2.5 Data Management Strategy

An effective data management strategy will support the Program and the Agency’s mission to improve the healthcare status of the AI/AN people. The data management strategy will respect the cultural and sensitivity of the tribal community while informing management and supporting decisions that impact clinical, financial, and operational activities. Data stewardship should ease the burden of collection, protect privacy, enhance clinical safety, manage usage, record release, and assist with reporting and retention.

Action steps have been outlined within organizational goals that impact data management and align with expected conceptual concerns which include enterprise architecture, interoperability and data sharing, data security and privacy, patient engagement using tools such as the patient portal, analytics and business intelligence, endpoint reporting needs and challenges, data warehouse, and governance. Additional consideration was given to end-users through a recent (2019) data call that highlighted areas for improvement such usability, medical device integration, and artificial intelligence.

Effective data strategy will:

• Support compliance of regulatory requirement of Enterprise Architecture (EA) and the Federal Information Technology Acquisition Reform Act (FITARA)

• Improve delivery of healthcare services

• Optimize clinical and administrative resources

• Support interoperability and sharing of health records allowing for enhanced patient health record data

• Engage patients in their care, foster participation in their treatment plans and accountable for treatment plan compliance

• Build trust and confidence and improve timely decision-making for providers.

• Allow data to flow across the I/T/U ecosystem, third-party providers, and government bodies to reduce burden to the patient and to help manage unnecessary cost of healthcare

• Adopting data security and privacy norms will gain consensus for the I/T/U ecosystem to the concerns…