B08_SOL_-_Attachment_A_-_IHS_4DW_PWS_3.pdf

Indian Health Service

HEALTH INFORMATION TECHNOLOGY

MODERNIZATION PROGRAM

Performance Work Statement

Four Directions Warehouse (4DW)

March 27, 2024

Performance Work Statement Health Information Technology Modernization Program

Acquisition Sensitive

Table of Contents 1 Purpose 2 Background 3 Scope of Work 4 Performance Details

4.1 Period of Performance

4.2 Place of Performance

5 Tasks and Deliverables

5.1 Task 1: Project Management

5.1.1 Project Kick-Off Meeting

5.1.2 Project Management Plan

5.1.3 Quality Assurance Surveillance Plan (QASP)

5.1.4 Staffing Approach

5.1.5 Onboarding

5.1.6 Access and Credential Management

5.1.7 Meetings and Reports

5.2 Task 2: Engineering and Technical Management

5.2.1 Life Cycle Support

5.2.2 Architecture and Engineering Design

5.2.3 Requirements Management

5.2.4 Design and Configuration

5.2.5 Change Control

5.2.6 Program Reviews

5.2.7 Risk Management

5.2.8 Technical Data Management

5.2.9 Privacy and Security Engineering

5.3 Task 3: Establishment of the 4DW Environment

5.3.1 Cloud Environment

5.3.2 Continuity of Operations and Disaster Recovery

5.3.3 Configuration Management

5.3.4 ATO and Security Configuration/Assessment

5.4 Task 4: Clinical Data Repository (CDR) Services

5.4.1 CDR Database

5.4.2 CDR Management Services and Interfaces

5.4.3 CDR Reporting Service

5.5 Task 5: Data Migration Services (DMSs)

5.5.1 Data Migration Service Capabilities

5.5.2 Data Migration Operational Execution

5.6 Task 6: Cold Storage Archive (CSA) Services

5.7 Task 7: Vendor Neutral Archive (VNA) Services

5.8 Task 8: Enterprise Master Patient Index Service (EMPI)

5.9 Task 9: Clinical Data Viewer (CDV)

5.10 Task 10: Integration, Testing, and Implementation

5.10.1 Integration

5.10.2 Testing

5.10.3 Implementation and Release

5.11 Task 11: Operation and Management

5.11.1 Operations Support

5.11.2 Maintenance Support

5.11.3 Training and User Documentation Support

5.12 Task 12: 4DW Optional Tasks

5.12.1 Project Transition

5.13 Deliverable Table

5.14 Performance Requirements

6 General requirements

6.1 Multi-Contractor Environment

6.2 Key Personnel

6.3 Security Requirements

6.4 Identification of Contractor Personnel

6.5 Personnel Security

6.6 Program Cybersecurity Requirements

6.7 Government-Furnished Equipment

6.8 Government-Furnished Information

6.9 Data Rights

6.10 Section 508 – Information and Communication Technology (ICT) Standards

6.11 Documenting Hours Worked and Tasks

6.12 Travel and Other Direct Costs

6.13 Organizational Conflicts of Interest

6.14 American Indian and Alaska Native Nations and Cultures

7 Applicable Documents 8 List of Acronyms

List of Tables Table 1: Deliverable Table Table 2: Performance Metrics

1 PURPOSE

The purpose of this Performance Work Statement (PWS) is to describe the work necessary to extract, transform, load, archive, seed, and serve data for interoperability and analytics applications from legacy and current electronic health record systems as well as associated interdependent health information technology applications and systems in support of the Indian Health Service (IHS) Health Information Technology (IT) Modernization Program.

2 BACKGROUND

IHS, an agency within the Department of Health and Human Services, is the principal federal health care provider and health advocate for American Indian and Alaska Native (AI/AN) people. Its goal is to raise their health status to the highest possible level through a comprehensive health service delivery system. The strategic goals of IHS are:

Ensure that comprehensive, culturally appropriate personal and public health services are available and accessible to AI/AN people

Promote excellence and quality through transformation of IHS into an optimally performing organization

Strengthen IHS program management and operations

IHS supports a comprehensive direct and public health service delivery system through a network of hospitals and clinics located in 37 states across the country, largely in extremely rural areas. IHS headquarters is in Rockville, Maryland, and the agency’s health care operations are administered through 12 area (regional) offices. More detailed information on the location and types of facilities and services is available through the IHS website (www.IHS.gov/aboutihs/).

IHS health care system comprises three broad components, collectively known as the IHS, Tribal, and Urban (I/T/U) Indian health system:

I (IHS): 24 hospitals (including five Critical Access Hospitals [CAHs]), 51 health centers (outpatient at least 40 hours per week), 24 health stations (outpatient less than 40 hours per week), and six Youth Regional Treatment Centers (YRTCs) directly managed by IHS

T (Tribal): 22 hospitals (nine CAHs), 279 health centers; 79 health stations; 59 Alaska Village Clinics; and six YRTCs operated by Tribes that have exercised their self-determination prerogatives under the authority of Public Law 93-638 Indian Self-Determination and Education Assistance Act, as amended (ISDEAA)

U (Urban): 41 Urban Indian Health Organizations funded under the Indian Health Care Improvement Act of 1976

To deliver on its mission, the health IT systems and infrastructure in use at IHS must be modernized and concepts of operations updated to successfully transform the IHS health care system to be highly effective and sustainable, while recognizing the needs of AI/AN people, including their unique traditions and culture. As a direct result of the multi-year Health IT Modernization Program, IHS expects to achieve the following outcomes to align with IHS Strategic Goals and the IHS Strategic Plan FY 2019-2023:

Improved access to services for AI/AN people seeking care from the I/T/U Indian health system

Improved patient engagement through electronic access to health information

Improved health status for AI/AN people receiving care from IHS

All IHS facilities, as defined in Appendix D of the Health IT Modernization Statement of Objectives (SOO), will have optimal support for their status as Patient Centered Medical Homes

Improved quality of care provided by IHS, as demonstrated by Government and industry benchmarks

Improved interoperability and the ability to share patient information within the organization, across the I/T/U health system, and with private and Government partners (e.g., Department of Veterans Affairs [VA], Centers for Medicare & Medicaid Services [CMS], and others)

Improved organizational maturity in use of IT systems in service of the IHS mission

A complete and regularly updated Security Risk Analysis

Improved ability for IHS to provide services in a sustainable way through cost recovery

Clinical and business operations user satisfaction with Health IT usability

Development of the Four Directions Warehouse (4DW) is a critical component of IHS’s Health IT Modernization Program and the decommissioning of the current IHS Resource and Patient Management System (RPMS) and implementation of the Modernized Health IT Solution. Details regarding the capabilities and technical components of RPMS can be found at: https:/IHS.gov/RPMS. To support the IHS, Tribal, and Urban (I/T/U) health care delivery operations, the 4DW will provide the following initial technical capabilities within 1 year from date of award:

The ability to store clinical and administrative designated record set (DRS)1 in a clinical data repository (CDR) within the 4DW infrastructure.

The ability to archive all clinical and administrative patient data from legacy and other EHR databases in accordance with (IAW) IHS-specified records retention and disposition schedule.2

The ability to store and archive medical imaging studies and scanned clinical and administrative documents IAW IHS-specified records retention and disposition schedule.3

The ability to support migration of select data from the 4DW to the new electronic health record (EHR) system.

3 SCOPE OF WORK

The scope of work includes, but is not limited to, the following capabilities and services:

Project Management (Section 5.1): This task includes planning, implementation, and execution of project tasks prescribed in this PWS using the Enterprise Performance Life Cycle Framework (EPLC).4

Engineering and Technical Management (Section 5.2): This task includes the formulation of use cases/user stories; elicitation of system requirements; design of the system, subsystems, and functional components; testing (unit and system levels); user validation (user acceptance testing); and formulation of system sustainment and operations.

Establishment of the 4DW Environment (Section 5.3): This task includes support to the Government in conducting the following:

- Risks associated with obtaining the authorization to operate (ATO)

- Analysis of alternatives of cloud computing and related technologies

1 See 45 CFR Section 164.501 for definition of Designated Record Set (DRS).

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.501 2 See IHS Disposition Schedule 3: Professional Services.

https://www.ihs.gov/DRPC/recordsmanagement/dispositionschedule3/ 3 Ibid.

4 Department of Health and Human Services. (2012). Enterprise Performance Life Cycle Framework— Overview Document. Department of Health and Human Services (HHS).

https://www.hhs.gov/sites/default/files/ocio/eplc-lifecycle-framework.pdf https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.501 https://www.ihs.gov/DRPC/recordsmanagement/dispositionschedule3/ https://www.hhs.gov/sites/default/files/ocio/eplc-lifecycle-framework.pdf

- Management of 4DW configurations

- Design of business continuity of operations (COOP) for the 4DW.

Clinical Data Repository (CDR) Service (Section 5.4): This task includes supporting the Government in the formulation of CDRs including, but not limited to, the engineering, implementation, and operations of CDRs and the management of CDRs for reporting clinical quality measurements.

Data Migration Service (Section 5.5): This task is the engineering and operations of health IT services for migrating clinical data from the legacy systems to the new EHR system.

Cold Storage Archive (CSA) Service (Section 5.6): This task is the implementation of records management and the operation of archive storage for health records in accordance with the IHS Disposition Schedule 3 – Professional Services.5

Vendor Neutral Archive (VNA) Service (Section 5.7): This task is similar to the CSA service but is the implementation of records management and the operation of archive storage for medical images and scanned clinical documents. The operation of VNA shall adhere to the IHS Disposition Schedule 3 – Professional Services.6 Additionally, VNA will include capabilities that provide for the viewing of multiple document types including DICOM.

Enterprise Master Patient Index (EMPI) Service (Section 5.8): This task is to implement and operate an MPI service for the enterprise. This means EMPI service will also be implemented in the 4DW environment.

Clinical Data Viewer (Section 5.9): This task is to identify, select, implement and maintain the optimum data viewer for both the CDR and CSA in the 4DW. In general, the retention period of health records for IHS is 75 years since the last encounter. An analysis of alternatives (AoA) will be conducted periodically to determine an optimum solution for viewing clinical data.

5 Disposition Schedule 3 | Records Management. (n.d.). Division of Regulatory and Policy Coordination.

Retrieved June 30, 2023, from https://www.ihs.gov/DRPC/recordsmanagement/dispositionschedule3/ 6 Ibid

4 PERFORMANCE DETAILS

4.1 Period of Performance

The period of performance will comprise a base year and four (4) option years. The base year will begin upon contract award and will end 12 months thereafter.

4.2 Place of Performance

Services under the terms of this PWS are to be conducted at both designated contractor facilities and IHS offices or another site designated by IHS as needed. Pre-authorization processes shall be followed for any required travel related to this PWS.

The contractor is responsible for conducting business generally between the hours of 0700 -1800 Monday through Friday with core work hours between 0900-1500 Eastern Time. The contractor shall maintain a skilled workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed. When hiring personnel, the contractor shall consider the stability and continuity of the workforce to be essential.

“Core work hours” are the primary working hours of Division of Health Information Technology Modernization and Operations (DHITMO), during which the contractor’s key personnel must be reachable and available to meet and/or collaborate with the Government and other contractors.

The Contractor must provide 24/7/365 after-hours coverage for emergency situations on an as-needed basis. The government will determine when an emergency situation arises;

these can include but are not limited to critical system failures due to software errors, database failures, or significant database upgrades that must be performed after normal business hours.

4.3 Base and Optional Labor:

This PWS includes Base and Optional Labor categories. The Base labor is the labor anticipated to fulfill deliverables throughout the software development lifecycle for the current known strategic priorities. Optional labor is an estimated contingency to accommodate the potential need for additional services resulting from such things as congressional mandates, inspector general corrective actions, and healthcare public emergencies. The government may choose to assign a specific task order through contract modification outlining which specific optional labor resources are needed.

4.4 Other Direct Costs

This category includes expenses associated with activities required to perform the tasks of this PWS (i.e. software toolkit licenses, and related expenses). ODCs on this contract are limited to those required software tools necessary to perform the tasks within this PWS that are not already part of the contractor’s established software toolkit inventory. Each purchase must be requested in advance and be accompanied with appropriate cost estimates and economy. All ODCs must be authorized by the COR and CO and shall not exceed a total of $75,000 per period of performance.

5 TASKS AND DELIVERABLES

The tasks within this PWS specify the activities for establishment and sustainment of the 4DW production system. Throughout this PWS, the term “establish” is defined as creating new or configuring existing capabilities for deployment and use in the IHS Health IT Modernization architecture. It is inclusive of the conception, architecting, designing, developing/configuring, testing, deploying, operating, and maintenance of the 4DW solution via its constituent parts.

This term “establish” is preferred over the term “develop” as it relates to solution technical components, because the 4DW solution is anticipated to be composed mostly of commercially available off the shelf products and capabilities configured to support IHS requirements, and the foundational services desired from the 4DW are readily achievable by configuring these commercially available services.

The term “deployment” is still used within this PWS only in reference to the creation of deliverable products, models, and artifacts. Another term used frequently is “collaborate.” Collaborate refers to contributing to IHS technical product development, where the vendor will respond and answer technical questions and action items as necessary to provide data, unique insight, or validate Health IT Modernization related community efforts and products.

5.1 Task 1: Project Management

The Project Management task requires the contractor to plan, monitor, and manage the tasks and subtasks outlined in this PWS. Activities shall include: program and project planning; program and project earned value tracking and Investment Management reporting to HHS, contributions to policy and process development; aligning with Agency enterprise architecture; and capital planning and investment control. High level program and project management shall result in a roll up of data from the individual projects to the respective Federal Investment Manager.

The Government Contracting Officer (CO), Contract Specialist, (CS) and the Contracting Officer’s Representative (COR) will be the contractor’s key point of contact.

The contractor’s Program Manager will be COR’s key point of contact. The COR will determine the appropriate lines of communication with the contractor for the delivery of contracted services.

The contractor shall submit deliverables to IHS in an IHS-approved electronic format.

All materials must be reviewed and approved by IHS and, where necessary, meet IHS guidelines. The Government, through the COR, will review and approve all work products and deliverables submitted by the contractor.

The COR will determine the process for final approval and acceptance of all deliverables. Acceptance of deliverables will be based on an assessment of technical accuracy, clarity, timeliness, sufficient level of detail, and completeness.

Deliverables shall be complete, well-written, and meet contractual requirements. The contractor shall proofread all deliverables, regardless of whether they are in draft or final version, prior to delivery to IHS.

5.1.1 Project Kick-Off Meeting

The contractor shall conduct a kick-off meeting at IHS’s offices, or another site designated by IHS. At this meeting, the contractor shall present its overall approach to meeting IHS’s needs and for ensuring quality deliverables over the course of the contract. The kick-off meeting shall include the following topics:

Management Approach: To include project assumptions, risk management and constraints, and the overall approach to project management.

Project Management Plan (PMP): To include the methodology for implementing the project in a phased approach and a preliminary project schedule, including general task descriptions, task dependencies, task durations, milestones, resources, and deliverables for each short- and long-term phase, and identification of the critical path.

Quality Assurance Surveillance Plan (QASP): The contractor shall submit a draft of their proposed QASP.

Staffing Approach and Plan: To include the roles, responsibilities, and allocations of each staff resource assigned to the effort; the approach to transitioning staff between each life cycle phase; and the approach to estimating levels of resources required. The contractor shall provide procedures for proposing new key personnel, removing established key personnel, and replacement of key personnel in the event of removal.

Communication Approach: To include the methodology for communicating status, issues, and risks to IHS, through the COR.

Onboarding: The contractor shall present their Onboarding Plan describing its progress on onboarding key personnel and other staff as well as working with other IHS and IHS staff to gain an understanding of the ongoing work.

5.1.2 Project Management Plan

The contractor shall develop a Project Management Plan that includes the methodology for implementing the project in a phased approach and a draft Integrated Master Schedule (IMS). The IMS shall include general task descriptions, task dependencies, task durations, milestones, resources, and deliverables for each near- and long-term phase, and the identification of critical path activities. The PMP shall contain all deliverables, project tasks, staffing, the contractor’s staffing approach and plan, and associated timeframes.

The contractor shall provide dependent milestones and schedule information to the Health IT Modernization program at regular intervals and as requested by the COR.

5.1.3 Quality Assurance Surveillance Plan (QASP)

The COR will use a Quality Assurance Surveillance Plan (QASP) throughout the life of the contract to ensure that the contractor is performing the services required by this PWS at an acceptable level of performance. The contractor shall provide a draft QASP and a Performance Requirements Summary (PRS). The contractor’s QASP shall explain how the contractor’s own project-level quality control program will ensure services are performed in accordance with the contract. In the QASP, the contractor shall detail procedures to identify, prevent, and ensure non-recurrence of defective work products and services. The PRS is a report on the contractor’s actual performance of program management services in accordance with the contract. The PRS shall be aligned with the structure and content of the QASP and include the contractor’s assessment of its achievement of the performance measures included in this PWS.

The contractor shall maintain quality control processes and procedures necessary to ensure its products and services meet the requirements of this contract. The contractor shall identify, record, track, and correct issues and/or problems affecting the performance of this contract, including its deliverables and the timing of the deliverables. The contractor shall immediately provide the COR with written notification of any issues that will materially alter the contractor’s performance of this PWS as soon as the contractor becomes aware of the issue. The contractor shall submit the records of any issues/problems to the COR upon request.

5.1.4 Staffing Approach

The contractor shall maintain a highly qualified staff of personnel to perform the requirements of the individual tasks and deliverables.

The contractor shall ensure that team personnel obtain security badging as required and that all team personnel take Government-required training.

The Program Manager is the contractor’s representative responsible for managing the full scope of this PWS. The Program Manager shall be responsible for all staff employed and all work performed under the PWS. The Program Manager shall be held accountable for the outcomes of the work performed and the resolution of obstacles to achieving the outcomes necessary for success under the PWS. Specific responsibilities include ensuring that deadlines are met; workflow is coordinated across simultaneous, ongoing tasks; work is performed within the project’s allotted budget; and documents are provided to IHS in a timely manner and adhere to IHS’s quality expectations. In addition, the Program Manager ensures that any concerns raised by IHS are appropriately addressed in a timely manner. The contractor shall ensure that all contractor personnel assigned to this contract who function as Project Managers are in possession of a valid Project Management Professional (PMP) certification or other nationally recognized project management certification credentials.

5.1.5 Onboarding

The contractor shall ensure that all required onboarding activities for all applicable personnel are completed in a timely and efficient manner. The contractor will be expected to adhere to the processes defined in the latest version of the DHITMO Onboarding Standard Operating Procedure (SOP) as provided. Onboarding activities include, but are not limited to:

Delivery and implementation of an Onboarding Plan, which includes, but is not limited to:

- The contractor’s designated POCs for onboarding activities.

- An onboarding schedule with tasks, activities, durations, milestones, resource allocation, IHS knowledge transfer sessions, and dates for completion of onboarding work.

- Risks and associated risk mitigation plans for onboarding.

Participation in Onboarding meetings.

The contractor’s team members’ completion of personnel security requirements and required training courses. Required training courses include, but are not limited to:

- Identity Management Training

- Records Management Training

- Information Systems Security Awareness Training

- Cultural and Health Care Practice Norms of the AI/AN Communities Training

Engagement in activities that will result in the contractor gaining an understanding of the business objectives, processes, and requirements related to the services required.

The contractor shall ensure that all necessary and appropriate contractor personnel under the contract receive and maintain IHS network credentials.

5.1.6 Access and Credential Management

The contractor shall be responsible for maintaining all accounts and access credentialing of personnel assigned under this contract. To maintain compliance with the security requirements, all contractor personnel with IHS network credentials are required to:

Log in to the IHS network a minimum of once every 30 calendar days to maintain an Active network credential. Accounts that are not used in a 30-day calendar day period are automatically inactivated and require re-processing by the COR and prevents the Inactive user from performing their contractual duties until the account is reactivated.

Renew HSPD-12 PIV card certificates annually and promptly when notified. Once a PIV card certificate expires, it may prevent the user from performing their contractual duties until the certificates are properly renewed. Any additional travel or labor time required to renew expired certificates will be done at the cost of the contractor.

Renew HSPD-12 PIV cards promptly and prior to expiration as required by current regulation. Once a PIV card expires, it may prevent the user from performing their contractual duties until the card is properly re-issued. Any additional travel or labor time required to re-issue expired cards will be done at the cost of the contractor.

5.1.7 Meetings and Reports

5.1.7.1 Progress and Status Meetings

The contractor shall conduct weekly progress meetings and monthly status meetings to keep the COR, IHS Health IT Modernization Program Manager, and designated Federal Technical Leads informed of project status. These meetings shall be run by the contractor, and the contractor shall provide meeting materials (including the agenda) and conference lines at least one full business day prior to each meeting. (For instance, the weekly meeting materials for a 9:00 am Monday weekly meeting would be due to IHS by 9:00 am on the preceding Friday.) The contractor shall maintain meeting minutes for the weekly progress meetings and the monthly status meetings. In addition, if requested by IHS, the contractor shall maintain meeting minutes for any other meetings held for the project. The contractor shall submit all meeting minutes to IHS within one business day after the respective meeting. All minutes shall capture the key discussions and decisions from the meeting and include, at a minimum, the attendees, the action items, the outstanding issues discussed at the meeting, the contractor staff responsible for managing each action item and/or outstanding issue, and any other information determined necessary by IHS. The contractor shall separately maintain a current record of all action items and outstanding issues for the entire performance period, including those that have been resolved or closed.

Unless otherwise directed by the COR, the standing agenda items for the weekly progress meetings shall include:

Review of accomplishments to date, remaining activities to be completed, and the status of the project compared with its schedule.

Significant findings, if any, that include but are not limited to, findings that negatively affect schedule or risk.

Significant problems encountered or anticipated and their impact on the schedule of the project.

Contractor’s plans to resolve identified problems.

Additions to the Issues Table since the last meeting, and during the current meeting.

Review of all outstanding issues and their statuses.

Questions and answers.

5.1.7.2 Monthly Progress Report

For the monthly status meetings, the contractor shall also prepare monthly progress reports, outlining all work accomplished during the previous month as a means of ensuring that the expenditure of resources is consistent with, and shall result in, successful completion of all tasks within projected cost and schedule limitations. The contractor shall submit the monthly progress reports to the COR a minimum of three full business days prior to the monthly status meeting. (For instance, the monthly progress report for a Wednesday meeting at 9:00 am would be required to be received at IHS by 9:00 am on the preceding Friday.) At a minimum, each monthly progress report shall:

Describe the accomplishments during the previous month by task, remaining activities to be completed by task, and the status of each task compared with its schedule.

Discuss any significant problems encountered or anticipated by task, and the problem’s potential or actual impact on the schedule or costs of the project.

Include the contractor’s plans to resolve the identified problems.

Include data on planned versus actual expenditures by task and in total for the project.

Include any other data determined necessary by IHS.

5.1.7.3 Monthly Financial Report

Accompanying the monthly progress reports, the contractor shall submit monthly financial reports, outlining all spending during the previous month as a means of ensuring that the expenditure of resources is consistent with, and shall result in, successful completion of all tasks within projected costs and schedule limitations. The financial report shall be submitted in accordance with the standard DHITMO Financial Management Status Reporting format. The reports include, but are not limited to the following:

Task name

Period of performance

Month of the reporting period

Number of hours and cost expended for each labor category during the reported month, by task and for the project

Cumulative hours and cost expended for each labor category, by task and for the project

Cumulative total cost incurred to date, by task and for the project

Itemization of travel and other direct costs incurred

A summary of costs incurred during the month of the reporting period in a format approved by IHS

Projected monthly hours and funds still needed to complete each task

Funds and hours remaining to be incurred on each task, based on the contractor’s cost proposal

Notification of when the contract is within 75% of total cost awarded overall, or by task

A narrative report explaining why expenditures exceed 10 percent either above or below the estimated expenditures for the period of time that is being reported.

The contractor’s submitted invoices shall show costs both in total and by task

5.1.7.4 Teleconferences

In addition to the meetings discussed above, the contractor shall conduct status meetings virtually with the IHS Health IT Modernization Program Manager, Federal Leads, COR, or other designee, as well as ad hoc teleconferences where deemed necessary by the IHS Health IT Modernization Program Manager, Federal Leads, and/or COR. The purpose of these teleconferences is to raise, discuss, and resolve issues related to specific tasks of this contract. The frequency of these teleconference meetings will vary by task, or as otherwise determined by IHS. If requested by IHS, the contractor shall maintain meeting minutes for any of these meetings, in accordance with requirements described in Section 5.1.7.1: Progress and Status Meetings.

5.2 Task 2: Engineering and Technical Management

Engineering management and technical management are related fields, with engineering management being responsible for the overall success of technical projects and technical management being the application of management principles during a project, to include the planning, organizing, directing, and controlling of workflows. For 4DW engineering and technical management, the contractor shall:

1. Provide 4DW engineering services with respect to all aspects and life cycle phases which includes, but is not limited to, planning, requirements analysis, design, coding and unit testing, system integration testing, implementation, maintenance and updating of systems, applications, and/or services, healthcare information processing, financial management systems, decision support systems, and workflow management systems.

2. Provide engineering and technical management services. The contractor shall be fully cognizant of the implications that the IHS strategic plan and other prevailing IHS strategic goals and objectives7 have on their engineering efforts. Any misalignments, concerns, and risks detected by the contractor shall be communicated to DHITMO, no later than the next status meeting or monthly progress report.

3. Provide DHITMO with engineering and technical services that address the activities involved in the planning, execution management, and deployment of the

7 https://www.ihs.gov/strategicplan/ https://www.ihs.gov/strategicplan/

4DW. This task includes planning and managing the scope of the contract, communicating with stakeholders to explain complex technical concepts, managing program and technical risk, and ensuring compliance with all applicable regulations and standards.

4. Provide engineering expertise to analyze system concepts, system design and interoperability, and provide recommendations related to the development, testing, and sustainment of the 4DW solution.

5.2.1 Life Cycle Support

IT life cycle services are a broad range of technical management functions that help manage a project throughout its life cycle. For 4DW Life Cycle Support Services, the contractor shall:

1. Provide systems/software engineering support for all phases of the 4DW solution life cycle. The contractor shall support the full range of life cycle development, architecture, and operations support services assessments, interfaces, including software installation, configuration and customization as needed, deployment, training, and troubleshooting for the 4DW program. In this context, engineering support includes, but is not limited to:

Formulation of use cases/user stories Elicitation of operational and functional requirements Identification of key measurement of effectiveness (MOE) and measurement of performance (MOP) Design of the system and allocation of functions to system components Conduct of verification and validation at the unit, system level Support of the user in conducting system acceptance testing Maintenance and sustainment of system operations

2. Provide a sufficient number of dedicated and fully qualified resources to support the full spectrum of the development life cycle from requirements elicitation to post-release user support for the 4DW system. It is preferred that software development roles are filled by dedicated Full Time Equivalents (FTEs) due to the complex nature and aggressive timelines associated with product development.

3. Collaborate with relevant DHITMO personnel to conduct program planning as applicable. Planning shall include nominal program management tasking and planning associated with the development of program artifacts.

4. Develop, publish, and maintain an easy-to-understand, integrated product roadmap that depicts the integrated release of new capabilities, products, services, meta-processes, and significant infrastructure updates. The purpose of the roadmap is to serve as a stakeholder communication tool and to enable program integration of product iteration and release cycles.

5. Provide Health IT consulting and SME services related to the development, sustainment, and operation of the 4DW and accompanying programmatic policies and standard operating procedures. Contractor services include development, review, approval, and version control of required program documentation.

6. Establish and maintain an effective quality control program to ensure services are performed in accordance with this PWS.

7. Develop a 4DW Quality Assurance and Quality Control Plan (QA/QCP). The QA/QCP shall include the contractor’s approach to both quality assurance and quality control and shall map both assurance and control processes to the contractor’s selected development methodology. The quality assurance segment of the plan shall be comprehensive in that it shall cover all aspects of quality management by the contractor organization and establish a framework for preventing quality problems. The quality assurance segment of the plan shall also discuss how the 4DW components, products, and services will meet customer expectations. The quality control segment of the plan shall focus on validating that 4DW applications and services meet or exceed desired quality standards.

8. Provide a Quarterly Program Management Review to report status on the deliverables in the performance work statement.

9. Develop and maintain a “lessons learned and corrective action summary and tracking list.” The contractor shall continuously manage this content to support and realize elements of continuous process improvement.

10. Provide services related to analysis, design, evaluation, implementation, and testing of interactive computing systems for human use to include, but that are not limited to, 508 compliance assessments.8

5.2.2 Architecture and Engineering Design

Architecture and engineering are disciplines associated with designing, building, and managing IT systems. For 4DW architecture and engineering support, the contractor shall:

1. Provide the technical support to conceptualize, design, develop, configure, document, review, integrate, test, deploy, and monitor 4DW applications, user

8 See HHS Conformance Checklist and document templates. https://www.hhs.gov/web/section- 508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html interfaces, application program interfaces (APIs), web services, observability, and associated information processing routines.

2. Architect and design the establishment of the following 4DW application services:

Clinical Data Repository (CDR) and associated CDR data management Data Migration Service Cold Storage Archive Vendor Neutral Archive Enterprise Master Patient Index Clinical Data Viewer

3. Provide 4DW architecture services in support of establishment and integration of the 4DW, to include the development of Health IT Modernization current state and future state capability models, data models, application inventories, and technical design patterns.

4. Develop System Engineering and Development Plan (SEDP), design plans, and technical reports as specified in the individual task order.

5. Develop 4DW solution architecture and product engineering models using Unified Architecture Framework (UAF) artifact definitions and data attributes. The contractor shall deliver all solution architecture artifacts in both graphic form and tabular form, where the graphics may or may not be generated from tabular data but shall be consistent in content. Each 4DW solution architecture artifact and model shall be delivered as content within the appropriate Technical Manual.

6. Develop 4DW architecture artifacts that align with Unified Architecture Framework.9 Include relevant views and diagrams in the technical manual appropriate to that view. Each 4DW solution architecture artifact and model shall be delivered as content within the appropriate 4DW Technical Manual.

7. Develop 4DW designs that are in alignment with IHS modernization plans, IHS strategic priorities, and projected infrastructure limitations and updates. 4DW solution design artifacts and models shall be delivered as content within the appropriate 4DW Technical Manual.

8. Design the 4DW solution architecture plan to fully address PHI and PII data resources throughout the life cycle of the 4DW.

9 See Object Management Group (OMG). (n.d.). Unified Architecture Framework | Object Management Group. Introduction to “Unified Architecture Framework.” Retrieved October 2, 2023, from https://www.omg.org/uaf/ https://www.omg.org/uaf/

9. Collaborate with IHS divisions within OIT, including the Division of Information Security, which specifies agency-level security requirements and policy, and the Division of IT Operations, to acquire and integrate with IHS operational and maintenance support services, IHS infrastructure system administration services, and IHS directory services.

10. Develop three (3) AoA Technical Studies that address the 4DW environment and application services (see Section 5.3 and 5.3.2). Each AoA shall have a minimum of two (2) alternatives identified in collaboration with IHS to support solution architectural decisions and 4DW Design. As part of this support, the contractor shall participate in a multidisciplinary IHS-led team to identify the most balanced technical solutions among a set of proposed viable solutions. AoA technical studies and services shall align with the contractor proposal, and may address application design, cloud native and commercially available capabilities, user-centered research and design, requirements research and analysis, business process analysis, workflow design, task flow analysis, data architecture, database design, and systems design.

5.2.3 Requirements Management

Requirements management (RM) is the process of defining, documenting, managing, and controlling the requirements for a system or application. It involves the gathering, analysis, prioritization, documentation, validation, and verification of solution requirements. For 4DW requirements management, the contractor shall:

1. Perform requirements analysis, system analysis, development and implementation support for core functional business and support applications and services, process re-engineering, and adaptation of information technology solutions in support of environments internal and external to the organization.

The contractor shall perform requirements definition and management (RDM) services to support product development for each 4DW application service.

2. Develop 4DW business and performance requirements. This delivery shall be inclusive of functional and non-functional requirements addressing the full spectrum of 4DW capabilities. Requirements shall be at a moderate level of detail, sufficient for non-technical staff to understand what requirement-based expectations are sufficient to develop acceptance test scenarios and factors, but not so detailed that they address elements such as user clicks, menu selection, or specific user forms. 4DW requirements may be delivered as a tabular or spreadsheet only based product.

3. Develop a 4DW Requirements Traceability Matrix (RTM) that captures bi-directional traceability from functional requirements to 4DW application services, components, use cases, test cases, pass-fail scenarios, and unresolved defects.

4DW RTM may be delivered as a tabular or spreadsheet only based product.

Manage the traceability between technical requirements elements, test cases, test execution logs, and defects via Requirements Traceability Matrix (RTM) using an IHS-approved requirements data structure to capture, track, maintain, update, change, and test requirements in a consistent manner.

4. Coordinate with DHITMO to develop a requirements management plan and requirement management repository. The COR shall provide the format and structure of the repository.

5.2.4 Design and Configuration

4DW design and configuration activities are the steps taken to realize 4DW functional and architecture requirements, including the identification and selection of capability services and the specification of their initial configuration. For 4DW design and configuration, the contractor shall:

1. Develop a 4DW solution architecture and design, to be used in the establishment of the 4DW. Elements of the solution architecture shall be captured and documented as appropriate in each of the relevant 4DW Technical Manuals, as well as 4DW Administrative Guides and SOPs.

2. Develop architecture and design elements using the UAF models and artifacts for inclusion in 4DW Technical Manual as well as 4DW Administrative Guides and SOPs. UAF artifacts shall be delivered both as a graphic, where appropriate, and in tabular form, via Excel or comma separated values.

3. Support the technical deliberations of the Health IT Modernization technical governance bodies with technical expertise on an as needed basis.

4. Capture all system dependencies, interfaces, and performance thresholds of 4DW components necessary to establish the 4DW. Confirm that all threshold values align with minimum Government-specified performance measures.

5.2.5 Change Control

IT change control services are a set of processes and tools to help organizations manage the introduction of changes to their IT systems. The contractor shall:

1. Provide comprehensive change control services in support of the established processes.

2. Provide change control activities that include, but are not limited to, updating/maintaining the Requirements Management Plan and Standard Operating Procedures documents, change control process workflow management, product backlog reporting, assisting members of the project teams in the use of the change control processes and tools, reviewing change requests and requirements for quality standards, introducing change requests into the

DHITMO Change Control Board (CCB) queue and coordinating subsequent requests for supporting documentation, and meetings.

3. Develop a 4DW Change Control Guide and SOP. This deliverable shall document and include the 4DW change control process, procedures, and methods.

4. Manage a 4DW change control backlog that contains both non-functional and functional applications, components, and tools that comprise the 4DW solution architecture and IHS capabilities request that can be transitioned into the 4DW planning cycle and updates to the 4DW release baseline.

5.2.6 Program Reviews

Program reviews are conducted to evaluate the status, effectiveness, and progress of a program. For 4DW reviews, the contractor shall:

1. Perform and collaborate on the scheduling of 4DW EPLC reviews and technology demonstrations. The contractor shall seek and obtain COR approval prior to conducting any program review or demonstration.

2. Conduct the following reviews and demonstration to the IHS Health IT community established by and scheduled in coordination with the COR. 4DW reviews and demonstration may be held remotely or in person, as determined by the COR.

The type and number of reviews and demonstrations are as follows:

4DW Solution Design Review: Conduct a 4DW solution design review for DHITMO and other 4DW stakeholders, as established by the 4DW COR. The 4DW review shall include any 4DW capabilities specified with this PWS and requested by the IHS COR. The contractor shall coordinate with the COR to establish the schedule and capability set to be demonstrated at specific points during 4DW development.

4DW Test Readiness Review for each 4DW test event: Conduct 4DW test readiness review capability demonstrations for DHITMO and other 4DW stakeholders, as established by the 4DW COR. The 4DW demonstration shall include any 4DW capabilities specified with this PWS and requested by the IHS COR. The contractor shall coordinate with the COR to establish the schedule and capability set to be demonstrated at specific points during 4DW development.

4DW Release Readiness Review: Conduct a release and operational readiness review to obtain IHS approval of feature completion and a go, no-go, go-live decision on 4DW deployment into operations.

4DW Capability and Interoperability Demonstrations: Conduct 4DW capability and interoperability demonstrations for DHITMO and other 4DW stakeholders, as established by the 4DW COR. The 4DW demonstration shall include any 4DW capabilities specified with this PWS and requested by the IHS COR. The contractor shall coordinate with the COR to establish the schedule and capability set to be demonstrated at specific points during 4DW development.

4DW Application Capability Demonstration: Provide the relevant documentation and presentations to accompany each 4DW technical and program review. The contractor shall deliver review material no later than (NLT) three business days prior to review.

5.2.7 Risk Management

Risk management evaluates threats to technical, cost, and schedule performance. For 4DW risk management, the contractor shall:

1. Perform 4DW risk management by assessing, identifying, documenting, and monitoring 4DW risks. The contractor shall coordinate with IHS business and technical staff to gather and capture possible 4DW risks and place all potential risk into the IHS risk registry. Support DHITMO risk tracking effort by contributing 4DW risks for inclusion in the Health IT Modernization risk registry and providing weekly updates of all 4DW related risks.

2. Perform risk assessment and mitigation for all IHS risks associated with the 4DW and related activities. Risk assessment and mitigation shall include cost, schedule, and/or performance concerns associated with each risk.

3. Develop a 4DW Risk Management Plan. This risk management plan shall apply to all EPLC phases, and address the planning, documentation, activities, and artifacts associated with 4DW risk management.

5.2.8 Technical Data Management

Technical Data Management is about understanding and protecting Government intellectual property, data rights, and curating relevant technical documents and artifacts to maximize options for product support and life cycle performance. For 4DW technical data management, the contractor shall:

1. Develop or acquire 4DW deliverable and reference content to be posted to the IHS Health IT Modernization SharePoint site for Government and contractor users. The contractor shall post all pre-approved, non-sensitive, deliverable products and supportive technical reference project documentation to the Health IT Modernization SharePoint site.

2. Curate the library of publications provided by the contractor, updating the library upon the release of any new version of the publication, or replacing the publication if it is superseded by a new regulation/publication.

3. Develop and maintain a 4DW Program Delivery Status Log listing of all documents and versions housed in the deliverable SharePoint repository.

4. Develop a 4DW Quarterly Solution Performance Report and Dashboard that summarizes 4DW application service and environment performance…