Electronic Health Records: DOD and VA Efforts to Achieve Full Interoperability Are Ongoing; Program Office Management Needs Improvement
Released: 2009-07-28T00:00:00

Letter

Background

The use of information technology (IT) to electronically collect, store, retrieve, and transfer clinical, administrative, and financial health information has great potential to help improve the quality and efficiency of health care and is important to improving the performance of the U.S. health care system. Historically, patient health information has been scattered across paper records kept by many different caregivers in many different locations, making it difficult for a clinician to access all of a patient’s health information at the time of care. Lacking access to these critical data, a clinician may be challenged to make the most informed decisions on treatment options, potentially putting the patient’s health at greater risk. The use of electronic health records can help provide this access and improve clinical decisions.

As we have previously noted, electronic health records are particularly crucial for optimizing the health care provided to military personnel and veterans. While in military status and later as veterans, many DOD and VA patients tend to be highly mobile and have health records residing at multiple medical facilities within and outside the United States. Making such records electronic can help ensure that complete health care information is available for most military service members and veterans at the time and place of care, no matter where it originates.

Key to making health care information electronically available is interoperability—that is, the ability to share data among health care providers. Interoperability enables different information systems or components to exchange information and to use the information that has been exchanged. This capability is important because it allows patients’ electronic health information to move with them from provider to provider, regardless of where the information originated. If electronic health records conform to interoperability standards, they can be created, managed, and consulted by authorized clinicians and staff across more than one health care organization, thus providing patients and their caregivers the necessary information required for optimal care. Paper- based health records—if available—also provide necessary information, but unlike electronic health records, do not provide decision support capabilities, such as automatic alerts about a particular patient’s health, or other advantages of automation.

Interoperability depends on the use of agreed-upon standards to ensure that information can be shared and used. In the health IT field, standards may govern areas ranging from technical issues, such as file types and interchange systems, to content issues, such as medical terminology. DOD and VA have agreed upon numerous common standards that allow them to share health data. They have also participated in numerous standards- setting organizations tasked to reach consensus on the definition and use of standards. For example, DOD and VA officials serve as members and are actively working on several committees and groups within the Healthcare Information Technology Standards Panel. The panel identifies and harmonizes competing standards and develops interoperability specifications that are needed for implementing the standards.

Interoperability can be achieved at different levels. At the highest level, electronic data are computable (that is, in a format that a computer can understand and act on to, for example, provide alerts to clinicians on drug allergies). At a lower level, electronic data are structured and viewable, but not computable. The value of data at this level is that they are structured so that data of interest to users are easier to find. At still a lower level, electronic data are unstructured and viewable, but not computable. With unstructured electronic data, a user would have to find needed or relevant information by searching uncategorized data. Beyond these, paper records also can be considered interoperable (at the lowest level) because they allow data to be shared, read, and interpreted by human beings. According to DOD and VA officials, not all data require the same level of interoperability, nor is interoperability at the highest level achievable in all cases. For example, unstructured, viewable data may be sufficient for such narrative information as clinical notes. Figure 1 shows the distinction between the various levels of interoperability and examples of the types of data that can be shared at each level.

DOD and VA Have Been Working to Exchange Health Information for Over a Decade

DOD and VA have been working to exchange patient health information electronically since 1998. We have previously noted their efforts on three key projects: The Federal Health Information Exchange (FHIE), begun in 2001 and enhanced through its completion in 2004, enables DOD to electronically transfer service members’ electronic health information to VA when the members leave active duty.

The Bidirectional Health Information Exchange (BHIE), established in 2004, was aimed at allowing clinicians at both departments viewable access to records on shared patients—that is, those who receive care from both departments. For example, veterans may receive outpatient care from VA clinicians and be hospitalized at a military treatment facility. The interface also allows DOD sites to see previously inaccessible data at other DOD sites.

The Clinical Data Repository/Health Data Repository (CHDR) interface, implemented in September 2006, linked the departments’ separate repositories of standardized data to enable a two-way exchange of computable health information. These repositories are a part of the modernized health information systems that the departments have been developing—DOD’s AHLTA and VA’s HealtheVet.

In their ongoing initiatives to share information, VA uses its integrated medical information system—the Veterans Health Information Systems and Technology Architecture (VistA)—which was developed in-house by VA clinicians and IT personnel. All VA medical facilities have access to all VistA information.

DOD currently relies on its AHLTA, which is comprised of multiple legacy medical information systems that the department developed from commercial software products that were customized for specific uses. For example, CHCS, which was formerly DOD’s primary health information system, is still in use to capture pharmacy, radiology, and laboratory order management. In addition, the department uses Essentris (also called the Clinical Information System), a commercial health information system customized to support inpatient treatment at military medical facilities. Not all of DOD’s medical facilities yet have this inpatient medical system.

DOD and VA Have Identified Interoperability Objectives

To facilitate compliance with the act, the Interagency Clinical Informatics Board, made up of senior clinical leaders from both departments who represent the user community, began establishing priorities for interoperable health data between DOD and VA. In this regard, the board is responsible for determining clinical priorities for electronic data sharing between the departments, as well as what data should be viewable and what data should be computable. Based on its work, the board established six interoperability objectives for meeting the departments’ data sharing needs. According to the former acting director of the interagency program office, DOD and VA consider achievement of these six objectives, in conjunction with capabilities previously achieved (e.g., FHIE, BHIE, CHDR), to be sufficient to satisfy the requirement for full interoperability by September 2009. The six objectives are listed in table 1.

GAO Reports Have Highlighted the Need for DOD and VA to Address Issues in Their Efforts to Share Health Information

Our prior reports on DOD’s and VA’s efforts to develop fully interoperable electronic health records noted their progress and highlighted issues that they needed to address to achieve electronic health record interoperability. Specifically, our July 2008 report noted that the departments were sharing some, but not all, electronic health information at different levels of interoperability. At that time the departments’ efforts to set up the interagency program office were in the early stages. Leadership positions in the office were not permanently filled, staffing was not complete, and facilities to house the office had not been designated. Accordingly, we recommended that the Secretaries of Defense and Veterans Affairs expedite efforts to put in place permanent leadership, staff, and facilities for the program office. The departments agreed with our recommendations and stated that they would take actions to address them.

Our January 2009 report noted that the departments had defined plans to further increase their sharing of electronic health information; however, the plans did not contain results-oriented (i.e., objective, quantifiable, and measurable) performance goals and measures that could be used as a basis to track and assess progress. We recommended the departments develop and document such goals and performance measures for the six interoperability objectives, to use as the basis for future assessments and reporting of interoperability progress. DOD and VA agreed with our recommendation and stated that the departments intended to include results-oriented goals in their future plans.

DOD and VA Have Taken Steps to Meet their Objectives, but Activities Are Expected to Remain after the Deadline for Achieving Full Interoperability

DOD and VA continue to take steps toward achieving full interoperability in compliance with applicable standards by September 30, 2009. In this regard, the departments have achieved planned capabilities for three of the interoperability objectives—refine social history data, share physical exam data, and demonstrate initial network gateway operation. The following information further explains DOD’s and VA’s activities with respect to these three objectives.

Refine social history data: The departments established this objective to enable DOD to share social history data captured in its electronic health record with VA. These data describe, for example, patients’ involvement in hazardous activities and tobacco and alcohol use. Our review of DOD and VA project documentation confirmed that the departments have achieved sharing of viewable social history data, thus providing VA with additional clinical information on shared patients that clinicians could not previously view.

Share physical exam data: The departments established this objective to implement an initial capability for DOD to share with VA the electronic health record information that supports the physical exam process when a service member separates from active military duty. To this end, the departments achieved the capability for VA to view DOD’s medical exam data through the BHIE interface, allowing VA to view outpatient treatment records, pre- and postdeployment health assessments, and postdeployment health reassessments, which are compiled for the DOD physical exam.

Demonstrate initial network gateway operation: DOD and VA want to demonstrate the operation of secure network gateways to support health information sharing between the departments. These gateways are to support health record data exchange, thus facilitating future growth in data sharing. As of early July 2009, the departments reported that five network gateways were operational and that data migration to two of the operational gateways had begun. The departments believed these five gateways satisfy the intent of the objective and will provide sufficient capacity to support health information sharing between DOD and VA as of September 2009. The officials stated, however, that they anticipate needing up to four additional gateways to support future growth in information sharing between the departments at locations and dates that are to be determined.

For the remaining three objectives, the departments have partially achieved planned capabilities, with additional work needed to fully meet the objectives. Regarding the objective to expand questionnaires and self- assessment tools, this additional work is intended to be completed by September 2009. With respect to the objectives to expand Essentris and demonstrate initial document scanning, department officials stated that they also intend to meet these objectives; however, additional work will be required beyond September to perform all the activities necessary to meet clinicians’ needs for health information. The following information further explains the departments’ activities with respect to these objectives.

Expand questionnaires and self-assessment tools: The departments intend to provide all periodic health assessment data stored in the DOD electronic health record to VA in a format that associates questions with responses. Health assessment data are collected from two sources: questionnaires administered at military treatment facilities and a DOD health assessment reporting tool that enables patients to answer questions about their health upon entry into the military. Questions relate to a wide range of personal health information, such as dietary habits, physical exercise, and tobacco and alcohol use. Our review of the departments’ project documentation determined that they have established the capability for VA to view questions and answers from the questionnaires collected by DOD at military treatment facilities; however, they have not yet established the capability for VA to view information from DOD’s health assessment reporting tool. Department officials stated that they intend to establish this additional capability by September 2009.

Expand Essentris in DOD: By September 30, 2009, DOD intends to expand Essentris to at least one additional site for each military service and to increase the percentage of inpatient discharge summaries that it shares electronically with VA to 63 percent. According to the acting director of the interagency program office, as of late June 2009, the departments had expanded the system to two Army sites (but not yet to an Air Force or Navy site) and were sharing 58 percent of inpatient discharge summaries. The acting director stated that the departments expect to meet their goal of sharing 63 percent of inpatient discharge summaries and expand the system to an Air Force and a Navy site by the September deadline. Nonetheless, the official stated that to better meet clinicians’ needs, DOD plans to further expand the inpatient medical records system. In this regard, the department has established a revised goal of making the inpatient system operational for 92 percent of DOD’s inpatient beds by September 2010.

Demonstrate initial document scanning: The departments intend to demonstrate an initial capability to scan service members’ medical documents into the DOD electronic health record and share the documents electronically with VA by September 2009. According to the program office acting director, the departments were in the process of setting up an interagency test environment to test the initial capability to query medical documents associated with specific patients as of late June 2009. He stated that the departments expect to begin user testing at up to nine sites by September 2009. According to this official, these activities are expected to demonstrate initial document scanning capability. However, after September, the departments anticipate performing additional work to expand their initial document scanning capability (e.g., completion of user testing and deployment of the scanning capability at all DOD sites).

DOD/VA Interagency Program Office Has Made Progress in Becoming Operational, but Is Not Fully Functioning as a Single Point of Accountability

The DOD/VA Interagency Program Office is not yet effectively positioned to serve as a single point of accountability for the implementation of fully interoperable electronic health record systems or capabilities. Since we last reported in January 2009, the departments have made progress in setting up the office by hiring additional staff, although they continue to fill key leadership positions on an interim basis. In addition, the office has begun to demonstrate responsibilities outlined in its charter, but is not yet fulfilling key IT management responsibilities in the areas of performance measurement, scheduling, and project planning.

Progress Made in Staffing Interagency Program Office

To address the requirements set forth in the act, the departments identified in the September 2008 DOD/VA Information Interoperability Plan a schedule and key activities for setting up the interagency program office. Since we last reported in January 2009, the departments have completed all but one of the activities identified in their schedule. For example, they have completed personnel descriptions for the office’s staff and have continued efforts to recruit and hire staff for both government and contractor positions. As of early July 2009, the departments had selected staff members for 10 of 14 government positions, an increase of 8 staff since our last report. The acting director of the office reported that recruitment efforts were underway to fill the remaining 4 positions by late September 2009. Further, all 16 contractor positions had been filled, an increase of 10 contractor staff since we last reported. Table 2 provides the status of selected key activities to establish the interagency program office.

However, while the departments have taken action toward hiring a full- time permanent director and a deputy director to lead the office, these positions continue to be filled on an interim basis. As of early July, DOD had selected a candidate for the director position, VA had concurred with the selection, and the candidate’s application had been sent to the Office of Personnel Management for approval. In the meantime, the departments requested and received an extension of the current acting director’s appointment until September 30, 2009, or until a permanent official is hired. Further, as of late June 2009, interagency program officials stated that actions were underway to fill the deputy director position and that VA was interviewing candidates for this position. According to the acting director, the departments anticipate making a selection for the deputy director position by the end of July 2009.

Interagency Program Office Has Not Fulfilled Key Management Responsibilities Identified in Its Charter

The January 2009 interagency program office charter describes, among other things, the mission and function of the office associated with attaining interoperable electronic data. The charter further identifies responsibilities of the office in carrying out its mission, in areas such as oversight and management, stakeholder communication, and decision making.

The office has taken steps toward fulfilling certain responsibilities described in its charter. For example, the office submitted its first annual report to Congress that summarized the departments’ efforts toward achieving full interoperability and the status of key activities completed to set up the office. Further, the office developed 11 standard operating procedures in areas such as program management oversight, strategic communications, and process improvement.

However, the office has yet to carry out other key responsibilities identified in its charter that are fundamental to effective IT program management and that would be essential to effectively serving as the single point of accountability. For example, the office has not yet established results-oriented (i.e., objective, quantifiable, and measurable) goals and performance measures for all six interoperability objectives—an action that we previously recommended that DOD and VA undertake.

Using results-oriented metrics to measure progress is an important IT program management activity because they can serve as a basis to provide meaningful information on the status of a program. As noted earlier, DOD and VA agreed with our recommendation calling for the establishment of results-oriented performance goals and measures. Further, the program office charter identifies the development of metrics to monitor the departments’ performance against interoperability goals as a responsibility of the office. Nonetheless, the office has only developed such a goal for one interoperability objective—expand Essentris in DOD. It has not developed results-oriented goals and measures for the other five objectives, instead stating that such goals and measures will be included in the next version of the DOD/VA Joint Executive Council Joint Strategic Plan (known as the joint strategic plan), which the office expects to complete by December 2009. If the departments complete the development of results-oriented performance goals and measures for their interoperability objectives, they will be better positioned to gauge their progress toward achieving fully interoperable capabilities and improving veterans’ health care.

Development of an integrated master schedule is also a key IT program management activity, especially given the complexity of the departments’ efforts to achieve full interoperability. According to DOD guidance, an integrated master schedule should identify detailed project tasks and the associated start, completion, and interim milestone dates; resource needs; and relationships (e.g., sequence and dependencies) between tasks.

While the program office has begun to develop an integrated master schedule as required by its charter, the current version does not include the attributes of an effective schedule. For example, the schedule included limited information for three of the six interoperability objectives (i.e., refine social history data, share physical exam data, and expand questionnaires and self-assessment tools). Specifically, the schedule included the name of each objective and a completion date of September 30, 2009. However, the schedule contained no information on tasks to be performed to meet the objectives. Further, the schedule did not reflect start dates, resource needs, or relationships between tasks for any of the six interoperability objectives. Without a complete and detailed integrated master schedule, the departments are missing another key activity that could be useful in determining their progress towards achieving full interoperability.

Similarly, development of a project plan is an important activity for IT program management. Industry best practices and IT project management principles stress the importance of sound planning for any project. Inherent in such planning is the development and use of a project management plan that describes, among other factors, the project’s scope, resources, and key milestones. The interagency program office charter identifies the need to develop a project plan, but, as of late June 2009, the office had not yet done so. Without a project plan, the departments lack a key tool that could be used to guide their efforts in achieving full interoperability.

In discussing these activities, the program office’s acting director and former acting director cited three reasons for why performance measurement, scheduling, and project planning responsibilities had not been accomplished. First, they stated that because it has taken longer than anticipated to hire staff, the office has not been able to perform all of its responsibilities. Second, the office’s interim leadership and staff have focused their efforts on providing to interested parties (e.g., federal agencies and military organizations) briefings, presentations, and status information on activities the office is undertaking to achieve interoperability, in addition to participating in efforts to develop a strategy for implementation of the Virtual Lifetime Electronic Record, which the President announced in April 2009. Finally, according to the officials, the office waited until June 2009 to begin the process of developing metrics so that they could do so in conjunction with the departments’ annual update to the joint strategic plan that is scheduled for completion in late 2009. However, without metrics to monitor progress, a complete integrated master schedule, and a project plan, the interagency program office’s ability to effectively provide oversight and management, including meaningful progress reporting on the delivery of interoperable capabilities, is jeopardized. Moreover, in the absence of these critical activities, the office is not effectively positioned to function as the single point of accountability for achieving full interoperability.

Conclusions

DOD and VA have continued to increase electronic health information interoperability. In particular, the departments have taken steps to meet their six interoperability objectives by September 30, 2009. However, for two of the six interoperability objectives, the departments subsequently plan to perform significant additional activities that are necessary to meet clinicians’ needs. Further, the departments’ lack of progress in establishing fundamental IT management capabilities that are specific responsibilities of the interagency program office contributes to uncertainty about the extent to which the departments will progress toward achievement of full interoperability by the deadline. While the departments have generally made progress toward making the program office operational, the office has not yet completed a project plan or a detailed integrated master schedule. Without these important tools, the office is limited in its ability to effectively manage and provide meaningful progress reporting on the delivery of interoperable capabilities that are intended to improve the quality of health care provided to our nation’s veterans.

Recommendation for Executive Action

To better improve management of DOD’s and VA’s efforts to achieve fully interoperable electronic health record systems, including satisfaction of the departments’ interoperability objectives, we recommend that the Secretaries of Defense and Veterans Affairs direct the Director of the DOD/VA Interagency Program Office to establish a project plan and a complete and detailed integrated master schedule.

Agency Comments and Our Evaluation

In written comments on a draft of this report, the DOD official who is performing the duties of the Assistant Secretary of Defense (Health Affairs) and the Acting Director of the DOD/VA Interagency Program Office concurred with our findings and recommendation. The VA Chief of Staff also provided written comments, in which the department concurred with our recommendation. In this regard, DOD and VA stated that they will provide the necessary information for the DOD/VA Interagency Program Office to establish a project plan and to complete a detailed integrated master schedule. If the recommendation is properly implemented, it should better position DOD and VA to effectively measure and report progress in achieving full interoperability.

Beyond its concurrence with the recommendation, the VA Chief of Staff stated that the department disagreed with the report’s characterization of the six interoperability objectives and expressed concern about the report projecting that the objective to demonstrate initial document scanning would not be completed by the September 30, 2009 deadline. Specifically, VA stated that our report portrayed the six interoperability objectives as the necessary steps to achieving full interoperability, even though the departments consider the objectives to be just one component of achieving full interoperability, along with existing data exchange capabilities. However, in discussing the objectives, we stated that according to the former acting director of the interagency program office, the departments consider achievement of the six objectives, in conjunction with capabilities previously achieved (e.g., FHIE, BHIE, CHDR), to be sufficient to satisfy the requirement for full interoperability by September 2009.

With respect to the objective to demonstrate initial document scanning, the Chief of Staff stated that our report projects that the objective will not be met by the September deadline. However, while our report states that according to the acting program office director, additional work will be required beyond September to perform all the activities necessary to meet clinicians’ needs related to document scanning, we did not report that the departments would not meet this objective by the September deadline. In fact, our report noted that according to this official the departments expect to begin user testing at up to nine sites by September 2009, and that these activities are expected to demonstrate initial document scanning capability. Nonetheless, we revised our report as appropriate, in an attempt to more clearly reflect the departments’ intent with regard to this objective.

DOD, VA, and the interagency program office also provided technical comments on the draft report, which we incorporated as appropriate. The departments and the DOD/VA Interagency Program Office comments are reproduced in app. II, app. III, and app. IV, respectively.

We are sending copies of this report to the Secretaries of Defense and Veterans Affairs, appropriate congressional committees, and other interested parties. In addition, the report is available at no charge on the GAO Web site at http://www.gao.gov.

If you or your staffs have questions about this report, please contact me at (202) 512-6304 or melvinv@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Key contributors to this report are listed in appendix V.

Appendix I: Scope and Methodology

To evaluate the Department of Defense’s (DOD) and Veterans Affairs’ (VA) progress toward developing electronic health record systems or capabilities that allow for full interoperability of personal health care information, we reviewed our previous work on DOD and VA efforts to develop health information systems, interoperable health records, and interoperability standards to be implemented in federal health care programs. We obtained and analyzed agency documentation and interviewed program officials to determine DOD’s and VA’s progress towards achieving full interoperability by September 30, 2009, as required by the National Defense Authorization Act for Fiscal Year 2008. We also analyzed information gathered from agency documentation to identify interoperability objectives, milestones, and target dates for ongoing and planned interoperability initiatives whose target dates extend beyond September 30, 2009. In addition, through interviews with cognizant DOD and VA officials, we obtained and assessed information regarding the departments’ plans for achieving full interoperability of electronic health information.

To determine whether the interagency program office is positioned to serve as a single point of accountability for developing and implementing electronic health records, we obtained and reviewed program office documentation, including its charter and standard operating procedures. We compared the responsibilities identified in the charter with actions taken by the office to exercise the responsibilities. Additionally, we interviewed interagency program office officials to determine the status of filling leadership and staffing positions within the office.

We conducted this performance audit at DOD and VA locations in the greater Washington, D.C., metropolitan area from April through July 2009, in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

Appendix II: Comments from the Department of Defense

Appendix III: Comments from the Department of Veterans Affairs

Appendix IV: Comments from the DOD/VA Interagency Program Office

Appendix V: GAO Contact and Staff Acknowledgments

Staff Acknowledgments

In addition to the contact named above, key contributions to this report were made by Mark Bird, Assistant Director; Rebecca Eyler; Lee McCracken; Michael Redfern; J. Michael Resser; Kelly Shaw; Eric Trout; and Merry Woo.