VA IT Modernization: Preparations for Transitioning to a New Electronic Health Record System Are Ongoing
Released: 2018-06-26T00:00:00

Letter

Background

VA’s mission is to promote the health, welfare, and dignity of all veterans in recognition of their service to the nation by ensuring that they receive medical care, benefits, social support, and lasting memorials. In carrying out this mission, the department operates one of the largest health care delivery systems in the United States, providing health care services to approximately 9 million veterans throughout the United States, Philippines, Virgin Islands, Puerto Rico, American Samoa, and Guam.

In 2015, we designated VA health care as a high-risk area for the federal government, and we continue to be concerned about the department’s ability to ensure that its resources are being used cost-effectively and efficiently to improve veterans’ timely access to health care. In part, we identified limitations in the capacity of VA’s existing IT systems, including the outdated, inefficient nature of certain systems and a lack of system interoperability as contributors to the department’s challenges related to health care.

Providing health care to veterans requires a complex set of clinical and administrative capabilities supported by IT. VA’s health information system—VistA—has been essential to the department’s ability to deliver health care to veterans. VistA contains an electronic health record for each patient that supports clinical settings throughout the department. For example, clinicians can use the system to enter and review patient information; order lab tests, medications, diets, radiology tests, and procedures; record a patient’s allergies or adverse reactions to medications; request and track consults; enter progress notes, diagnoses, and treatments for encounters; and enter discharge summaries.

VistA was developed in house by clinicians and IT personnel in various VA medical facilities and has been in operation since the early 1980s. Over the last several decades, VistA has evolved into a technically complex system comprised of about 170 modules that support health care delivery at 152 VA Medical Centers and over 1,200 outpatient sites. In addition, customization of VistA, such as changes to the modules by the various medical facilities, has resulted in about 130 versions of the system—referred to as instances.

According to VA, VistA modules are comprised of one or more software applications that support various health care functions, such as providing care coordination and mental health services. In addition to VistA, the department has other health information systems that must interface with VistA to send, exchange, or store related health (e.g., clinical and patient) data.

Since 2001, VA has identified the need for enhancements and modifications to VistA and has pursued multiple efforts to modernize the system. Two major efforts have included the VistA Evolution program and, most recently, the planned acquisition of the same electronic health record system that the Department of Defense (DOD) is acquiring.

In 2013, VA established VistA Evolution as a joint program between OI&T and VHA that was comprised of a collection of projects and efforts focused on improving the efficiency and quality of veterans’ health care. This program was to modernize the department’s health information systems, increase VA’s data exchange and interoperability capabilities with DOD and private sector health care partners, and reduce VA’s time to deploy new health information management capabilities.

In June 2017, the former VA Secretary announced a significant shift in the department’s approach to modernizing VistA. Specifically, rather than continue to use VistA, the Secretary stated that the department planned to acquire the same Cerner electronic health record system that DOD has been acquiring.

Accordingly, the department awarded a contract to Cerner in May 2018 for a maximum of $10 billion over 10 years. Cerner is to replace VistA with a commercial electronic health record system. This new system is to support a broad range of health care functions that include, for example, acute care, clinical decision support, dental care, and emergency medicine. When implemented, the new system will be expected to provide access to authoritative clinical data sources and become the authoritative source of clinical data to support improved health, patient safety, and quality of care provided by VA.

As previously mentioned, this acquisition is being managed by VA’s EHRM program. According to program documentation, EHRM is also to deliver program management support and the infrastructure modernization required to install and operate the new system.

According to EHRM program documentation, the department has estimated that an additional $5.8 billion in funding, above the contract amount, would be needed to fund project management support and infrastructure improvements over the 10-year period. This amount does not fully include government employee costs.

Deployment of the new electronic health record system at the initial sites is planned for within 18 months of October 1, 2018, with a phased implementation of the remaining sites over the next decade. Each VA medical facility is expected to continue using VistA until the new system has been deployed at that location.

VA Has Reported Obligating about $3.0 Billion to VistA and Related Activities from Fiscal Years 2015 through 2017

According to VA, the department’s costs for VistA and related activities are approximated by funding obligations of about $1.1 billion, $899 million, and $946 million in fiscal years 2015, 2016 and 2017, respectively, for a total of about $3.0 billion over 3 years to support the system. Specifically, VHA and OI&T reported obligations to cover the costs for the VistA Evolution program, including costs for development, operation and maintenance, and payroll for government employees over the 3 fiscal years.

Further, in their efforts to fully determine the costs associated with VistA, VA officials also reported obligations for activities that supported VistA, but were not included in the VistA Evolution program. These other obligations were for investments in interoperability initiatives, such as increasing data standardization and data sharing between VA, DOD, and other government and non-government entities, and the Virtual Lifetime Electronic Record Health. These obligations also include other VistA- related technology investments, such as networks and infrastructure sustainment, continuation of legacy systems, and overall patient safety, security, and system reliability.

Table 1 provides a summary of the total VistA and related obligations that VA identified for fiscal years 2015 through 2017.

VA Is Working to Define VistA’s Scope and Identify Components to Be Replaced by the Cerner System

Understanding the scope of VA’s current health information system is essential to effectively planning for the new system. However, according to VA officials, there is no single information source that fully defines the scope of VistA. Instead, existing definitions of the system, including the components that comprise it, are identified by multiple sources. These sources include the VA Systems Inventory, VistA Document Library, and VA Monograph.

Each of these sources describes VistA from a different perspective. For example, the VA Monograph provides an overview of VistA and non-VistA applications used by VHA. The monograph also describes modules and their associated business functions, but does not document all customization at local facilities. The VA Systems Inventory is a database that identifies current IT systems at VA, including systems and interfaces that are related to VistA. The VA Document Library is an online resource for accessing documentation on VA’s nationally released software applications, including VistA.

In the absence of a complete definition of VistA, EHRM program officials have taken a number of steps to define the system’s scope and identify the components that the Cerner system will replace. These steps have included conducting two analyses, performing preliminary site assessments, and planning for Cerner to perform a detailed assessment of each site where the new system will be deployed.

Specifically, EHRM program subject-matter experts undertook an analysis that identified 143 VistA modules and 35 software applications as representing the scope of the system. They then compared the functionality provided by the VistA modules to the Cerner system’s capabilities to identify the VistA components that are expected to be replaced by the Cerner system. The analysis identified 131 (92 percent) of the 143 VistA modules and 32 (91 percent) of the 35 applications that are expected to be replaced by the Cerner system. For example, the analysis determined that the Care Management and Mental Health modules would be replaced by the new system.

EHRM program officials also undertook a subsequent, broader analysis to identify, among other things, the scope of VistA, as well as the department’s other health IT systems that could also be replaced by the Cerner system. These other systems include, for example, dentistry and oncology applications. As part of this analysis, the department combined data from the VA Systems Inventory, the VistA Document Library, the VA Monograph, and other sources to identify the health information technology environment at a typical VA medical center.

The resulting analysis of VA’s health IT environment identified a total of 330 applications that support health care delivery at a medical center, of which 119 applications (approximately 36 percent) have been identified as having similar functionality as a capability of the Cerner system. Further, 128 of the 330 applications are identified as VistA applications. Of the 128 applications designated as VistA, 58 (approximately 45 percent) have been identified as having similar functionality as a capability of the Cerner system, including pharmacy, laboratory, and scheduling capabilities.

In addition to the analyses discussed above, VA has taken steps to understand differences in VistA at individual facilities. Specifically, according to EHRM officials, representatives from VA and Cerner have visited 17 VA medical facilities to conduct preliminary site assessments. The intent of these assessments is to obtain a broad perspective of the current state of the systems, applications, integration points, reporting, and workflows being utilized at individual facilities. These site visits identified VistA customization that may be site specific. The identification of such site specific customization is intended to help Cerner plan for implementation of its system at each location. According to EHRM program officials, full site assessments that are planned at each location in preparation for implementation of the Cerner system are expected to identify the full extent of VistA customization.

VA’s Preparations for Transitioning from VistA to the Cerner System Are Ongoing

Since the former VA Secretary announced in June 2017 that the department would acquire the same electronic health record system as DOD, VA has taken steps to position the department for the transition to the new system. These actions, which are ongoing, have included standardizing VistA, assessing the department’s approach to increasing interoperability, establishing governance for the new program and the framework for joint governance with DOD, and preparing initial program plans.

Standardizing VistA

VA’s goal is for all instances of VistA being used in its medical facilities to be standardized where practical. Such standardization is intended to better position the department to switch to the Cerner system. To increase standardization, the VistA Evolution program has been focused over the last 5 years on standardizing a core set of VistA modules related to interoperability which, according to the department, accounts for about 60 percent of VistA.

In addition, the program has focused on identifying software that is common to each VistA instance. VA refers to this collection of standard software as the gold instance. As part of its effort to standardize VistA, VA has implemented a process to compare the system at each site with the gold instance. Sites that are identified as having variations from the gold instance must apply for a waiver to gain approval for continuing to operate a non-standard VistA instance. OI&T and VHA assess the waivers, which may be approved if a site needs non-standard functionality that is deemed critical to that site. Alternatively, waivers are not approved if the assessment determines that a site’s needs can be met by reverting to the gold instance of VistA.

Assessing the Approach to Increasing Interoperability

VA has identified increased interoperability as a key expected outcome of its decision to switch from VistA to the Cerner system. To ensure that the contract with Cerner will improve interoperability with community care providers (i.e., non-VA and third party providers), the former VA Secretary announced in December 2017 that the department had taken a “strategic pause” on the electronic health record acquisition process. During the pause, an independent study was undertaken to assess the approach to interoperability with the new acquisition. The assessment made recommendations to improve imported data, address data rights and patient safety risks, and improve data access for patients. VA agreed with all of the resulting recommendations and, according to EHRM program officials, included provisions in the contract with Cerner to address the recommendations.

Establishing a Program Office and Governance

Our prior work has identified strong agency leadership support and governance as factors that can increase the likelihood of a program’s success. Such leadership and governance can come from the establishment of an effective program management organization and a related governance structure.

VA has taken steps to establish a program management office and drafted a structure for technology, functional, and joint governance of the electronic health record implementation. Specifically, in January 2018, the former VA Secretary established the EHRM Program Executive Office (PEO) that reports directly to the VA Deputy Secretary. According to EHRM program officials, this office supported the contract negotiations with the Cerner Corporation and is expected to continue to manage the program going forward.

Program officials stated that the office is beginning the process of hiring full-time employees. In addition, to support the program office, the department has awarded a contract for project management support and has also reassigned a number of VA staff to the PEO.

Further, VA has drafted a memorandum that describes the role of governance bodies within VA, as well as governance intended to facilitate coordination between DOD and VA. For example, according to the draft memorandum, within VA, the EHRM Steering Committee is expected to provide strategic direction for the efforts while monitoring progresses toward goals and advising the Secretary on the progress and performance of the EHRM efforts. This committee is to include the Deputy Secretary, the Undersecretary for Health, and the Chief Information Officer, among others, and is to meet quarterly or as necessary to make its reports to the Secretary.

Additionally, according to EHRM program documentation, VA is in the process of establishing a Functional Governance Board, a Technical Governance Board, and a Governance Integration Board comprised of program officials intended to provide guidance; coordinate with DOD, as appropriate; and inform the Steering Committee. Further, a joint governance structure between VA and DOD has been proposed that would be expected to leverage existing joint governance facilitated by the DOD/VA Interagency Program Office.

Nevertheless, while the department’s plans for governance of the EHRM program provide a framework for high-level oversight for program decisions moving forward, EHRM officials have noted that the governance bodies will not be finalized until October 2018.

Preparing Initial Program Plans

Program planning is an activity for ensuring effective management of key aspects of an IT program. These key aspects include identification of the program’s scope, responsible organizations, costs, and schedules.

VA has prepared initial program plans, including a preliminary timeline for deploying the new electronic health record system to its medical facilities. The department also has a proposed 90-day schedule that depicts key program activities currently underway now that the contract has been awarded. For example, the department’s preliminary plans include an 8- year deployment schedule beginning with planned implementation at initial sites within 18 months of October 1, 2018.

According to the executive director for the EHRM program, the department also intends to complete a full suite of planning and acquisition management documents to guide the program. These documents include, for example, a life cycle cost estimate, a data migration plan, a change management plan, and an integrated master schedule to establish key milestones over the life of the project. EHRM PEO officials have stated that the department intends to complete the development of its initial plans for the program within 30 to 90 days of awarding the contract (between mid-June and mid-August 2018), and intends to update those plans as the program matures. The plans are to be reviewed during the milestone reviews identified in the department’s formal project management framework.

Critical Factors Underlying Successful Major Acquisitions

Our prior work has determined that successfully overcoming major IT acquisition challenges can best be achieved when critical success factors are applied. Specifically, we reported in 2011 on common factors critical to the success of IT acquisitions, based on seven agencies having each identified the acquisition that best achieved the agency’s respective cost, schedule, scope, and performance goals. These factors remain relevant today and can serve as a model of best practices that VA could apply to enhance the likelihood that the acquisition of a new electronic health record system will be successfully achieved.

Among the agencies’ seven IT investments, agency officials identified nine factors as having been critical to the success of three or more of the seven investments. These nine critical success factors are consistent with leading industry practices for IT acquisition. The factors are:

Active engagement of senior officials with stakeholders.

Qualified and experienced program staff.

Support of senior department and agency executives.

Involvement of end users and stakeholders in the development of requirements.

Participation of end users in testing system functionality prior to formal end user acceptance testing.

Consistency and stability of government and contractor staff.

Prioritization of requirements by program staff.

Regular communication maintained between program officials and the prime contractor.

Sufficient funding.

Officials for all seven selected investments cited active engagement with program stakeholders—individuals or groups (including, in some cases, end users) with an interest in the success of the acquisition—as a critical factor to the success of those investments. Agency officials stated that stakeholders, among other things, reviewed contractor proposals during the procurement process, regularly attended program management office sponsored meetings, were working members of integrated project teams, and were notified of problems and concerns as soon as possible. In addition, officials from two investments noted that actively engaging with stakeholders created transparency and trust, and increased the support from the stakeholders.

Additionally, officials for six of the seven selected investments indicated that the knowledge and skills of the program staff were critical to the success of the program. This included knowledge of acquisitions and procurement processes, monitoring of contracts, large-scale organizational transformation, Agile software development concepts, and areas of program management such as earned value management and technical monitoring.

Finally, officials for five of the seven selected investments identified having the end users test and validate the system components prior to formal end user acceptance testing for deployment as critical to the success of their program. Similar to this factor, leading guidance recommends testing selected products and product components throughout the program life cycle. Testing of functionality by end users prior to acceptance demonstrates, earlier rather than later in the program life cycle, that the functionality will fulfill its intended use. If problems are found during this testing, programs are typically positioned to make changes that would be less costly and disruptive than ones made later in the life cycle.

Use of the critical success factors described above can serve as a model of best practices for VA. Application of these acquisition best practices presents opportunities for the department to increase the likelihood that its planned acquisition of a new electronic health record system will meet its cost, schedule, scope, and performance goals.

In conclusion, VA continued to obligate billions of dollars for its VistA system. Recently, the department has undertaken important analyses to better understand the scope of the system and identify capabilities that can be provided by the Cerner electronic health record system it is acquiring. VA has additional key activities underway, such as establishing program governance and EHRM program planning. Based on these preliminary observations and as the department continues its activities to transition from VistA to the Cerner electronic health record system, critical success factors can serve as a model of best practices that VA could apply to enhance the likelihood that the acquisition of the new system will be successfully achieved. While it is early in VA’s acquisition of the Cerner system, it will be important for the department to leverage all available opportunities to ensure that its transition to a new system is carried out in the most effective manner possible. Our experience has shown that challenges can successfully be overcome through using a disciplined approach to IT acquisition management.

Chairman Roe, Ranking Member Walz, and Members of the Committee, this concludes my prepared statement. I would be pleased to respond to any questions that you may have.

GAO Contact and Staff Acknowledgments

If you or your staffs have any questions about this testimony, please contact David A. Powner at (202) 512-9286 or pownerd@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this testimony statement. GAO staff who made key contributions to this statement are Mark Bird (Assistant Director), Jennifer Stavros-Turner (Analyst in Charge), John Bailey, Rebecca Eyler, Jacqueline Mai, Scott Pettis, and Charles Youman.

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