Background VA’s mission is to serve America’s veterans and their families, and one of the ways it does so is by providing veterans with medical services. To help meet the health care needs of veterans, VHA is planning to complete approximately 70 new major medical projects between 2020 and 2024. Activation is one of the key steps that must occur before veterans can access care at these facilities. According to VA’s Activation Process Guide, activation typically involves activities such as planning for, purchasing, and installing new furniture, fixtures, and equipment (FF&E), ordering supplies, and hiring staff. For new buildings, the Guide states that activation activities begin when the building is being designed, continue through construction, and end when the facility is fully operational. The expenses associated with activation can reflect either one-time purchases or ongoing expenditures. One time purchases—called non- recurring activation expenses—involve the acquisition of assets such as furniture or equipment, or payment to a contractor for services such as equipment installation. Ongoing expenses, or expenses incurred more than once—called recurring activation expenses—are for staff salaries and consumable supplies, such as gowns and gloves. After a facility opens and begins serving patients, facilities are permitted to treat supplies and the salaries of new staff as activation costs until the site is serving enough patients to receive funding through one of VA’s regular funding processes, known as the Veterans Equitable Resource Allocation (VERA). Figure 1 provides examples of recurring and non-recurring activation expenses. The total cost of activation for major lease and major construction projects can be substantial. The median activation funding that facilities reported spending on major activations from fiscal year 2012 through 2018 was approximately $16 million. The four newest hospitals (in Denver, Las Vegas, Orlando, and New Orleans) spent a cumulative total of more than $1.9 billion for activation during this time period. The types of facilities undergoing activation can vary in size, services provided, and overall purpose within the VHA healthcare system, as shown in figure 2. For example, a community-based outpatient clinic (CBOC) is typically much smaller than a medical center but can provide primary, specialty, subspecialty, mental health, or any combination of delivery services that can be appropriately provided in an outpatient setting. Large medical centers can provide outpatient services as well as a broad range of inpatient services, including emergency services, surgery, and acute psychiatric care. Smaller facilities may refer patients to medical centers for complex treatment. National, regional, and local staffs play different roles in the activation process: National: VHA’s Activations Office—under the Office of Capital Asset Management (OCAM)—historically provided ad-hoc support to sites activating a major lease or construction project, such as providing on-site training related to the activation process and facilitating input from subject matter experts within VHA. The office also determines the base amount of activation funding that sites receive. Officials overseeing the office stated that its role is being reassessed and that the type of support it provides for activations may change in light of an internal reorganization and consideration for VA’s future growth plans. Regional: VHA’s18 regional networks, known as Veterans Integrated Service Networks (VISN), are responsible for the coordination and oversight of all administrative and clinical activities at health care facilities within their specified region. A VISN’s role in activation varies depending on the expertise available at the facility level, but VISNs can help facilities arrange contracts for services (like laundry or hazardous waste removal); review a facility’s budget submissions to VHA; and facilitate discussions with senior management or knowledge-sharing with other sites that have recently completed activation. The VISNs are also responsible for distributing activation funding from VHA. Local: In addition to providing medical services, medical centers function as administrative hubs for services in the area. As a result, the medical center director is ultimately responsible for activating facilities within the center’s administrative boundary. The medical centers can appoint staff to manage the activities required for activation. These staff can include the activations project manager, financial officers, and subject matter experts like interior designers. As a team, the staff are responsible for developing technical requirements, creating risk mitigation strategies, and deciding key acquisition dates, among other tasks. Activation Tasks Include Identifying and Fulfilling Staffing, Equipment, and Other Needs Planning and Execution of Activation Tasks Align with Building Acceptance and the First Day of Clinical Services While VHA has not identified standard milestones for activation, based upon our review of VHA documents and interviews with local and regional VHA officials, we found that two events are especially relevant to the planning and execution of activation activities: (1) building acceptance (when VHA formally takes possession of and occupies a building) and (2) providing medical services to the first patient. Figure 3 describes examples of activation activities in relation to these events, although the actual timing of tasks will vary depending on the needs of individual facilities. Activation Teams Begin Equipping and Staffing New Facilities Prior to Building Acceptance Officials from selected facilities said that prior to building acceptance, their activation activities typically focus on determining furniture and equipment needs, placing orders, anticipating staffing needs, and hiring new staff. Determining furniture and equipment needs is intertwined with the building design process, according to officials from three VHA facilities, because the design of the physical space can dictate what equipment is purchased. For example, a VHA official from one health-care center said that the activations team showed the medical care providers a mock-up of a treatment room and created cardboard models of furniture to help them select items. The official told us that getting the medical care team’s input early in the planning process can avoid the need to make costly changes in order to make the physical space fit the equipment or furniture requested by the medical care providers. Conversely, the building may be designed to accommodate specific equipment. For example: Officials from one facility shared the specifications of the radiology equipment with the team designing the building in order to leave a proper amount of space for the equipment. Similarly, an annex’s activation staff worked with the resident engineer to design an enclosed area separate from their main building for a mobile MRI machine. This design ensured a new MRI machine could be swapped out in the event of a breakdown without causing a disruption to the facility’s operations. Officials said that they also begin the purchasing process for equipment and furniture prior to building acceptance. VHA officials stated they work backwards from the construction endpoint to determine when to order items. VHA officials told us they need to place orders for certain items— such as high-tech equipment or made-to-order furniture—well in advance of the facility’s opening because the items are known to have long delivery times. For example: Officials from one clinic reported they ordered their facility’s imaging equipment 22 months before they needed it. Similarly, an official from a different clinic said that furniture is often not manufactured until it is ordered, so it can take several months to arrive. In contrast, the official said items like a staff refrigerator could be picked up at a local store within days and do not require substantial advance planning. Facilities also begin planning for their workforce needs prior to building acceptance. For example: An official from one clinic stated that facilities typically identify their staffing needs during this time period by position, title, and pay. Officials from an annex said that before their facility’s construction groundbreaking, they discussed how many staff would move from the old facility to the new facility, and how many new staff they expected to hire. After activation teams determine their staffing needs, facilities hire and begin training new staff. For example: An official from one clinic said that new staff needed to be trained prior to opening day, so it is not uncommon for staff to be hired and brought on-board before the facility begins providing clinical services. In the case of a very large facility, such as a medical center, hiring the required staff can require an extensive search that must commence before the building is finished. An official from a medical center said that a shortage of skilled medical workers required a nationwide search for suitable candidates. New Facilities Prepare for Patient Care after Building Acceptance Officials said that after a building is accepted as complete, activation typically focuses on tasks associated with moving into the space, such as equipment installation and training staff. For example: One clinic’s project calendar showed in the weeks leading up to opening day that the activations staff planned to install office furniture such as desks and filing cabinets, as well as to perform checks on biomedical equipment to ensure proper functioning. Officials from another clinic coordinated equipment and furniture deliveries between the warehouse (where items were being stored) and the new facility. The extent of staff training after building acceptance depends on the need to familiarize staff with the new facility, and the complexity of services offered. Activation staff might choose to have medical staff become familiar with the new facility by working at the facility prior to new operations. For example: One clinic’s staff started working in the building before their first patient was seen in order to become familiar with the new space. An official from a medical center said that facility staff adjusted to operating newer infrastructure, such as learning to operate a modern computerized boiler system. That official also stated that the medical center might need to conduct extensive training exercises to simulate 24/7 inpatient care. In contrast, outpatient facilities that do not operate around the clock may not have these same training needs. Activation Continues after Facilities Begin Providing Clinical Services Once a facility begins providing medical care, officials said that activation tasks are typically related to facility operations. These tasks can include on-the-job training in the new space and making necessary adjustments to the facility to ensure it runs properly while concurrently serving new patients. For example: An official at one clinic said that beginning patient care with a decreased workload, known as a “soft opening,” can help facilitate on- the-job training. The same official explained that this approach allows staff to become accustomed to their new facility’s operations and address any issues that may emerge without the demands of operating at full capacity. VHA officials from a health care center said that space adjustments included repositioning exam beds and ordering ergonomic chairs. Officials at several sites stated that they used SharePoint, an internal communication tool, to keep track of needed adjustments. This approach enables staff to monitor ongoing issues during the beginning of new operations, resolve unexpected problems, and track issues as they occur. Several VHA officials also said that some activation tasks —such as hiring staff—may occur after a facility begins serving patients. If a facility plans on a phased opening, in which some services will not be available on the first day, processes that would typically be completed earlier may take place during this time frame instead. For example, a medical center in our review utilized a phased-opening approach, as it expanded its capabilities with new medical services after opening. Selected Facilities Provided Most Clinical Services within Expected Time Frames, but Delays Occurred for a Variety of Reasons The facilities included in our review provided most medical services within planned time frames; however, nearly one-third of services were delayed for various reasons. Overall, 59 of the 87 services were offered within planned time frames (69 percent). Of the 28 services that were not provided on time, staffing, equipment size, “commissioning”, and procurement issues contributed to the delays, according to officials. Staffing issues delayed a total of 14 services in two of the seven facilities reviewed. One facility had 13 services with delays that ranged from 4 to 6.5 months. Officials said the delays were due to difficulties recruiting the staff necessary for those services, which included various types of surgery, radiology, and mental health, among others. Similarly, difficulties recruiting a dentist at a second facility delayed dental service 4 months beyond the expected delivery time frame. Equipment at one facility did not fit into some of the rooms and the space needed to be altered in order to accommodate it. Officials said that all 12 services were delayed by approximately 1 month so that the facility could open with all services available, though officials noted that the full extent to which the equipment issues contributed to these delays was unknown (i.e., there could have been other causes that they could not recall.) Commissioning issues delayed women’s healthcare services at one annex by approximately 1 month. Officials said that the air circulation rate—which needed to be higher in rooms where certain procedures are performed—was inadequate. As a result, the air exchange had to be improved before the facility could begin performing the planned clinical procedures. Procurement issues led to delays in providing radiology services at one facility. Officials told us that x-ray services were delayed by 3 months because the equipment was ordered through the centralized purchasing process, which took longer than local officials had anticipated. These delays primarily affected services that were originally planned to be offered within 2 months of building acceptance. While selected facilities planned to offer approximately 92 percent of services within 2 months of building acceptance, as shown in figure 4, 61 percent were actually offered within that time frame. VHA does not provide a guideline for how much time facilities should need after building acceptance to provide clinical services. Officials explained that the appropriate amount of time will vary based upon the scope of the project, including factors such as the number and kinds of services offered and the level of effort associated with installing the equipment (e.g., a replacement hospital will require more effort than a small outpatient clinic). Thus, we did not determine if facilities were allotting appropriate amounts of time to complete activation activities and serve patients. However, VA’s Activation Process Guide provides some information regarding when full services should be available. The Guide states that clinical services can be added for up to 6 months after opening day (i.e., the first day that patients receive any services at the facility). The Guide further states that facilities may expect to offer services gradually—versus all on opening day—when services are new to an area. Of the 87 services offered by the facilities in our review, 86 were offered within 6 months of opening day. The remaining service—a clinic that provides colonoscopy and other related procedures at one facility— opened on schedule approximately 11 months after opening day. This facility was replacing another facility that had not previously offered this service. Officials explained that because the service was new, they needed more time to develop and equip the space as well as hire staff, so they planned on offering this service later than services that were being transferred from the previous facility. VHA Lacks Processes and Clear Definitions to Estimate and Oversee Total Activation Costs VHA lacks processes to develop total cost estimates for major activations. Without total cost estimates, VHA is unable to determine whether actual activation expenses are higher or lower than planned. Furthermore, VHA does not have documentation that defines allowable activation costs, including what facilities can purchase with activation funding and when facilities should cease spending activation funds. As a result, VHA officials lack critical information to support decision-making about resource allocation, and are not well positioned to effectively identify and investigate deviations from planned spending. VHA Lacks Processes to Develop Total Activation Cost Estimates and Compare Them against Actual Costs VHA lacks processes to develop reliable total activation cost estimates for major activation projects and to compare actual costs against these estimates. According to our assessment of information from VHA, the current cost estimation process does not cover the full duration of activation and does not reflect best practices for developing reliable cost estimates. In addition, VHA officials said that until recently, the agency lacked the accounting mechanisms necessary to facilitate comparisons of a project’s total activation costs against estimated costs; however, while VHA now possesses these mechanisms, it has not documented the process for how the new information should be used. The Activations Office and facility activation staff annually develop cost estimates for the upcoming 3 fiscal years using (1) an activation cost model (the model) and (2) a cost template (the template). According to Activations Office officials, the model is managed by the Activations Office and uses inputs such as a facility’s square footage and project schedule. Activations Office officials also said that the template is typically completed by facility activation staff and includes inputs such as planned clinical services as well as estimated staffing, equipment, and supply costs. While the cost estimate is driven primarily by the model, information in the template is also considered before annual activation funds are distributed, according to Activations Office officials. Figure 5 shows the steps for determining and distributing annual activation funds. We determined that the model and template do not estimate costs for the entire duration of a facility’s activation. According to our review of facilities’ spending data, activation spending for a given facility can occur over more than 3 fiscal years. All eight of the facilities in our review, for example, spent activation funds over 4 or 5 fiscal years. Thus, the estimate the Activations Office would have developed at the beginning of these projects would not have reflected total activation costs. Moreover, we did not see evidence that VHA medical facilities independently develop total activation cost estimates that are appropriate to compare against total actual costs. None of the eight selected facilities we reviewed could provide total activation cost estimates appropriate for this use, according to officials at each facility. Officials from five facilities stated that they had not developed such estimates, an official from one facility said that an estimate could not be located and probably had never been done, and officials from two facilities said that such documentation could not be located. VHA officials said that the existing cost estimation tools reflected the budgeting process (i.e., the current fiscal year and two future years) and that they had not previously been required to develop a cost estimate for the entirety of activation. Officials noted that as the Activations Office’s role shifts to include more oversight, it will be important for the Office to have total cost estimates for activation; however, as of September 2019, VHA did not have any specific plans for how to collect estimates for a project’s entire activation cost. We also found that VHA’s current process for developing activation cost estimates does not fully align with best practices for developing cost estimates as established in the GAO Cost Guide (see table 1 below). VHA’s process minimally met 10 and did not meet 2 of the steps—each of which reflects multiple best practices—required to develop reliable cost estimates. A reliable cost estimate is critical to the success of any program, providing the basis for informed decision-making, realistic budget formulation and program resourcing, and accountability for results. VHA officials acknowledged that following these practices would be valuable for the activations process, and explained that the agency did not previously incorporate these practices because they had not assessed the strength of their activation cost estimation process in this manner. Lastly, the Activations Office does not compare existing estimates and actual activation costs. While the Activations Office develops activation cost estimates for the upcoming 3 fiscal years and has some capabilities to track activation costs, to date it has not compared the planned costs to actual expenses. According to Activations Office officials, they have historically been unable to track how activation funding was spent at the facility level, which impeded such comparisons. Starting in fiscal year 2020, officials from the Activations Office plan to use accounting codes associated with each activation project, which will allow them to track expenses at the facility level. An internal review conducted in mid-2019 by the department overseeing the Activations Office concluded that the agency needed to regularly assess the extent to which activations spent funds as planned. As of October 2019, however, officials said the office has not documented the process for how they will deploy their new accounting oversight capabilities, including which personnel would be responsible for conducting such comparisons, the frequency of comparisons, and any follow-up steps that would be considered in the event of significant differences. Without processes for estimating total costs and comparing them against actual expenses, the Activations Office is limited in its ability to improve resource planning, budgeting, and allocation—critical elements that support VA’s stated management priority to enhance data-driven decision-making. Further, guidance from the Office of Management and Budget states that agencies should obtain information on actual project costs and compare them against planned expenses so managers can have a clear understanding of how resources are being used and whether cost goals are being met. Documented processes for cost estimation and comparison would be particularly important in the case of large medical centers, whose activation costs are in the hundreds of millions of dollars. VHA’s Activations Office Has Not Clearly Defined Allowable Activation Costs or Spending Time Frames The Activations Office has not clearly defined what officials at local facilities can purchase with activation funding and how long activation funding should continue after opening day. Activations Office officials said that there is a general understanding that some expenses, such as medical equipment for new facilities or services, are activation expenses, and that the Activations Office intends to provide activation funding until the facility begins to receive VERA funding to cover operational expenses. However, there is no policy to inform facility activation staff of what they can purchase with activation funding and when funding will cease. In mid-2019, an internal review conducted by the department overseeing the Activations Office found that the lack of clarity regarding what could or could not be purchased should be remedied; however, as of September 2019, no specific plans have been established to define appropriate purchases. Officials we spoke with—both at the selected medical facilities and VISNs—expressed uncertainty about what expenses they could pay for using activation funding. Officials from two of eight facilities told us that there were times when they did not know if they should charge an expense to activation or another funding source, such as construction accounts. For example, officials at one facility told us that they were unsure whether construction or activation funds would pay for the special window blinds needed for the intensive care units. Officials at four of the VISNs also said that when contacted by medical facility officials for guidance on allowable expenses, there were times when they did not know if facilities should charge an expense to activation or another funding code. In addition, officials from the selected sites held differing views on how long they were eligible to receive activation funding from the Activations Office. Finance officials for one of the selected facilities said that activation funding is provided for up to 5 years, while officials from several other facilities said that activation funding is available until operational expenses are covered by VERA. Activations Office officials said that the latter interpretation is accurate and that this transition to ongoing VERA support should take place within approximately 2 years after opening day. However, an official from the Activations Office said that a few facilities have received funding from the Activations Office for more than 2 years after opening because there was no clear definition for when activation funding should cease. The lack of clear definitions regarding what constitutes allowable activation expenses and when activation funding should end limits VHA’s ability to consistently and accurately estimate and track activation costs. For example, similar facilities could develop varying total cost estimates due to different understandings of what expenses are allowable. VA management priorities include making data-driven decisions to improve resource planning, budgeting, and allocation. In addition, Standards for Internal Control in the Federal Government states that management should use quality information to achieve the entity’s objectives. Clear definitions on what expenses facilities should charge to activation accounts, and for how long, would improve the Activations Office’s ability to monitor activation costs and improve resource stewardship. Conclusions As VHA undertakes the process of replacing facilities to better reflect its focus on outpatient and specialized care, it is poised to spend hundreds of millions of dollars per year to equip and staff these new sites. However, VHA does not have a clear understanding of total costs and whether individual activation projects are spending funds effectively. Because VHA does not have a process for developing an estimate for the entire activation cost of a project, the agency lacks a critical baseline that can inform future spending decisions. In addition, because VHA lacks a process that describes how officials should compare actual expenses to that estimate, the agency has no mechanism to regularly identify and respond to unplanned differences in activation costs. Furthermore, defining allowable activation expenses would better position VHA to ensure total cost estimates are consistent from facility to facility. Lastly, additional clarification on how to estimate activation costs and compare them against actual expenses would help VHA to more effectively manage the activations process. Without processes and clear definitions associated with activation cost measurement, VHA does not have reasonable assurance that it will be able to effectively manage the resources associated with activation. Recommendations for Executive Action We are making the following four recommendations to VA: The Assistant Deputy Under Secretary for Health for Administrative Operations should develop and document a process for estimating total activation costs for major medical facility projects. This process should reflect the 12 steps for developing a reliable cost estimate outlined in the GAO Cost Guide. (Recommendation 1) The Assistant Deputy Under Secretary for Health for Administrative Operations should develop and document a process for comparing actual activation costs for major medical facility projects to estimates. This process should identify the personnel responsible for comparing the estimated costs to the actual expenses and document their responsibilities. (Recommendation 2) The Assistant Deputy Under Secretary for Health for Administrative Operations should define and document what items and services officials can purchase with activation funds. (Recommendation 3) The Assistant Deputy Under Secretary for Health for Administrative Operations should define and document when facilities should cease to spend activation funds. (Recommendation 4) Agency Comment We provided a draft of our report to VA for review and comment. VA provided written comments, which are reprinted in appendix II. VA concurred with all of our recommendations. VA further provided information on how it intends to address our recommendations, with target dates for completion in December 2020. We are sending this report to the appropriate congressional committees and to the Secretary of the Department of Veterans Affairs. In addition, this report is available at no charge on the GAO website at http://gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-2834 or vonaha@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Other key contributors to this report are listed in appendix III. Appendix I: Reported Activation Costs at Selected VHA Medical Facilities To understand the costs of the activations of the eight selected facilities, we asked activation officials at each facility to provide a breakdown of the activation costs by the following categories: (1) Furniture, Fixtures, and Equipment; (2) Staffing; (3) Supplies; (4) Other; and (5) Total Cost. We used these cost categories because these are the categories in the template that facilities complete to estimate activation costs. Appendix II: Comments from the Department of Veterans Affairs Appendix III: GAO Contact and Staff Acknowledgments GAO Contact Staff Acknowledgments In addition to the contact above, Heather Halliwell (Assistant Director); Alison Snyder (Analyst-in-Charge); Rose Almoguera; Brian Bothwell; Geoffrey Hamilton; Jason Lee; Terence Lam; Ethan Levy; Josh Ormond; Daniel Setlow; Laurel Voloder; Mary Weiland; and Elizabeth Wood made key contributions to this report.


Background VHA manages one of the largest health care delivery systems in the United States and is responsible for overseeing the provision of health care at VA medical facilities. VA relies on its EHR system—VistA—to document the delivery of health care services to veterans. VA’s VistA EHR System To facilitate care, clinical providers access patient medical records and document the care they provide in EHR systems. Patient information needs to be accessible and consistent to prevent risks to patients’ safety, particularly when shared between providers. Information that is electronically exchanged from one provider to another must adhere to the same standards to be consistently interpreted and used in EHRs. In our prior work, we found that EHR technology has the potential to improve the quality of care that patients receive and to reduce health care costs. VistA has served as VA’s EHR system for more than 30 years. Over the last several decades, it has evolved into a technically complex system that comprises about 170 modules that support health care delivery at more than 1,500 medical facilities. In addition, customization of VistA, such as changes to the modules by the various medical facilities, has resulted in approximately 130 versions of the system VA-wide. Furthermore, as we have reported, VistA is costly to maintain and does not fully support VA’s need to electronically exchange health records with other organizations, such as DOD and community providers. VA and DOD have historically operated separate EHR systems. In addition to patient data from its own EHR system, VA relies on patient data from DOD to help ensure that it has access to the necessary health information that could assist clinicians in making informed decisions to provide care to service members transitioning from DOD to VA’s health care system. We have previously reported on VA’s challenges in managing health information technology and modernizing VistA. In 2015, we designated VA health care as a high-risk area for the federal government, in part due to its information technology challenges. Specifically, we identified limitations in the capacity of VA’s existing information technology systems, including the outdated, inefficient nature of key systems and a lack of system interoperability, as contributors to the department’s challenges related to health care. In our 2019 update to the high-risk series, we stressed that VA should demonstrate commitment to addressing its information technology challenges by stabilizing senior leadership, building capacity, and finalizing its action plan for addressing our recommendations, and by establishing metrics and mechanisms for assessing and reporting progress. We also have issued numerous reports over the last decade that highlighted the challenges facing VA in modernizing VistA and improving EHR interoperability with DOD. EHR Modernization Efforts, Including Goals of Improved Sharing of Health Information between VA and DOD VA created the Office of Electronic Health Record Modernization in 2018 to lead its EHRM program effort, which was intended to result in a more modern EHR system that would improve providers’ ability to deliver care, and share health data, including between VA and DOD and between VA and community providers. For example, with improved interoperability, medical providers would have the ability to query data from other sources while managing chronically ill patients, regardless of geography, or the network on which the data reside. In June 2017, the VA Secretary at the time announced that the department planned to acquire and configure the same EHR system that DOD is currently implementing across the military health system. According to the VA Secretary, the department decided to acquire the same system as DOD because it would allow all of VA’s and DOD’s patient data to reside in one system, thus assisting the departments in their goals of enabling seamless care between VA and DOD without the exchange and reconciliation of data between two separate systems. As VA planned to implement the same system DOD is implementing, experts recommended that VA and DOD coordinate to ensure that the departments could leverage efficiencies and minimize variation between the departments’ EHR system configurations when practical. DOD’s initial implementation of the Cerner EHR system occurred between February and October 2017 at four military treatment facilities in the state of Washington. In September 2019, the system was implemented at four additional military treatment facilities in California and Idaho. DOD plans to continue to implement the EHR system in 23 phases through 2023 with the next implementation expected to take place at eight additional military treatment facilities in California and Nevada. EHR System’s Implementation Timeline VA’s EHRM program originally planned to implement the Cerner EHR system at two VA medical facilities in spring 2020 with a phased implementation of the remaining facilities over the next decade. The EHRM program chose the Mann-Grandstaff VA Medical Center in Spokane, Wash. and the VA Puget Sound Health Care System in Seattle, Wash. as its initial operating capability sites. Information gathered from these sites will be used to help VA make EHR system configuration decisions and standardize work processes for future locations where the commercial EHR system will be implemented. In August 2019, the EHRM program adjusted its schedule to implement the commercial EHR system at these two sites in two phases, known as capability sets 1 and 2: Capability set 1 includes key EHR functionalities necessary to implement the system at the Mann-Grandstaff VA Medical Center, a level 3—that is, less complex—facility. Capability set 1 was originally scheduled for implementation in March 2020. Capability set 2 includes remaining functionalities necessary to implement the system at the VA Puget Sound Health Care System, a level 1—that is, highly complex—facility, in the fall of 2020. In February 2020, VA postponed the implementation of the Cerner EHR system at the Mann-Grandstaff VA Medical Center until July 2020. According to VA officials, the additional time will allow Cerner to develop and establish a more complete and robust training environment, as requested by VHA clinicians and other facility staff. In addition, according to VA EHRM program officials, the implementation delay will allow VA and Cerner to have time to develop additional interfaces between the Cerner EHR system and other VA systems, such as VA’s mail-order pharmacy system. These officials told us that the delayed implementation of the Cerner EHR system at the Mann-Grandstaff VA Medical Center was not expected to impact VA’s timeline for implementing the EHR system at the VA Puget Sound Health Care System in the fall of 2020. In April 2020, the VA Secretary announced that the department had shifted priorities to focus on caring for veterans in response to the pandemic created by the Coronavirus Disease 2019 (COVID-19). Further, the Secretary directed the EHRM program to allow clinicians who had been participating in EHRM program activities to focus on caring for veterans. According to program officials, they paused the implementation of the EHR system and were assessing the impact of the COVID-19 pandemic on VA’s planned implementation schedule. VA Used a Multi-Step Process to Make EHR Configuration Decisions and Assess System Compatibility VA’s EHRM program used a multi-step process to make EHR system configuration decisions for the Cerner EHR system being implemented at the VA Mann-Grandstaff Medical Center and Puget Sound Health Care System. This process included forming EHR councils and convening these councils at national and local workshops to make configuration decisions used by VA’s contractor, Cerner, to configure the new EHR system. The EHR councils also assessed the compatibility of the EHR system with the processes VA clinicians and staff follow in delivering care. EHR councils. In fall 2018, VA’s EHRM program established 18 EHR councils, based upon specific clinical and administrative areas, to make VA-specific EHR system configuration decisions for these areas. Each EHR council included subject-matter experts from VA, such as health care providers in various clinical areas and other staff, as well as non-VA participants from DOD and Cerner. According to VA EHRM program officials, Cerner’s typical process for configuring its EHR system was modified to accommodate VA’s needs, which VA officials stated were more complex than those of Cerner’s commercial clients. According to Cerner officials, Cerner does not typically establish councils as part of its EHR system configuration process. National workshops. VA’s EHRM program planned and held eight national workshops from November 2018 to October 2019, during which members of all 18 EHR councils met to make standardized EHR system configuration decisions for the VA health care system. VA’s EHRM program utilized DOD’s version of the Cerner EHR system—MHS Genesis—as its starting point for the EHR system configuration process. During the workshops, Cerner assigned consultants to facilitate these workshops, who highlighted Cerner’s commercial best practices and prepared workflow designs, according to VA EHRM program and Cerner officials; facilitated EHR system configuration decision discussions and noted input from EHR council members and other session participants such as DOD representatives; held sessions that involved members from different EHR councils for system configuration decisions that required coordination between councils. For example, the Business Operations Council and the Ambulatory Council held joint sessions to address scheduling appointments for oncology patients; was responsible for identifying and documenting recommendations for EHR system configuration decision differences between VA sites, and each medical facility specialty/department; and provided weekly progress updates to VA that reflected overall progress of expected decisions to be completed compared to the actual approved EHR system configuration decisions during national workshops. Over the course of the eight national workshops, EHR council members were responsible for making EHR system configuration decisions in given clinical and administrative areas and communicating them to Cerner; providing progress updates to VA’s EHRM program and VA leadership; and notifying appropriate governing bodies (e.g., VHA program offices— such as the Office of Primary Care) of any local, state, federal, VISN, and department policies that impact configuration decisions. More specifically, each council discussed VA’s work processes and documented relevant information that informed the configuration of the EHR system, including: (1) “workflows”—”process maps” that capture the start-to-finish sequence and interactions of related steps, activities, or tasks for each work process that VA medical facilities follow. For example, VA has a medication administration workflow for describing the sequence of tasks needed for scanning a patient’s wristband and administering medication. (See fig. 1.) (2) “design decision matrices,” which are compilations of decisions and discussion topics that identify and resolve workflow questions to inform configuration decisions and support implementation of the EHR system. For example, the medication administration design decision matrix documents that clinicians should not be prevented from proceeding with medication administration if a patient’s wristband cannot be scanned. (See fig. 2.) (3) “data collection workbooks,” which capture all of the data needed to inform how the EHR system should be configured to support each workflow, such as user privileges and preferences. For example, a data collection workbook for medication administration includes data on user preferences and prescribing privileges. (See fig. 3.) The EHR system configuration decisions each council needed to make varied significantly in quantity and topic. For example, the Ambulatory Council, charged with focusing on primary care decisions, had over 200 EHR system configuration decisions to make, while the Behavioral Health Council had about 100. Once configuration decisions were made, the EHR councils assessed the compatibility of the configuration of the Cerner EHR system with VA work processes. To do so, VA’s EHR councils reviewed the capabilities of the system and identified work processes that the Cerner EHR system did not support (or only partially supported). For example, according to VA Mann- Grandstaff Medical Center staff, the Cerner EHR system did not originally interface with VA’s Patient Centered Management Module, which supports VA’s work processes for establishing provider-patient relationships. However, in March 2020, VA EHRM officials told us that the interface between the two systems would be available when the Cerner EHR system is implemented at the Mann-Grandstaff VA Medical Center, which was planned for July 2020. In addition, according to VA EHRM officials, Cerner is in the process of developing EHR system capabilities for prosthetics to support VA work processes. Furthermore, according to VA EHRM officials, Cerner has been documenting and tracking needed capabilities for EHR implementation and updating VA’s EHRM program accordingly. According to EHRM program officials, Cerner plans to include functionalities not available in capability set 1 in either capability set 2 or future capability sets, although the development of these capabilities is an ongoing process. Although the eight national workshops have concluded, since October 2019, these EHR councils have continued to meet as necessary, virtually, and in person, to complete capability set 1 and 2 configuration decisions. According to Mann-Grandstaff VA Medical Center staff, as of February 2020, VA still needed to make EHR system configuration decisions to address online prescription refills and assigning patients to primary care panels. Local Workshops. After standardized EHR system configuration decisions were made at the national workshops, they were reviewed at local workshops for site-specific needs. To do this, from December 2018 to October 2019, VA’s EHRM program held eight local workshops at each of the initial operating capability sites—the Mann-Grandstaff VA Medical Center and the VA Puget Sound Health Care System. Local workshops allowed VA and Cerner to identify variances from standardized EHR system configuration decisions made at the national workshops as well as manual processes that needed to be accounted for at local medical facilities. If variances were identified, Cerner reported them to the appropriate EHR councils. While VA tried to minimize the variances in system configuration decisions, in certain cases, necessary alternatives to these configuration decisions were approved for local medical facilities if practicable. For example, according to a Cerner official, the national emergency room triage workflow originally called for an emergency department registrar to register a patient; in response to input from a local workshop, VA developed an alternative workflow, in which an emergency department registered nurse completes the step if a VA facility does not have an emergency department registrar. If there were no variances, EHR system configuration decisions were approved and reported to Cerner to configure the EHR system. According to EHRM program officials, VA plans to hold local workshops in advance of the Cerner EHR system implementation at future VA medical facilities to focus on site-specific configuration decisions. Cerner will continue to facilitate these future local workshop sessions and configure the EHR system based on decisions made at these sessions. Figure 4 provides an overview of the EHR councils’ process for making system configuration decisions. VA Met Its Schedule for Making Initial EHR System Configuration Decisions, and Has Formulated a Schedule for Remaining Efforts VA Met Its Schedule for Making System Configuration Decisions for Capability Set 1 VA met its schedule for making EHR system configuration decisions for capability set 1, which was scheduled for initial implementation at the Mann-Grandstaff VA Medical Center in July 2020. In addition, VA has formulated a schedule for remaining EHR system configuration decisions for capability set 2, which it planned to implement at the VA Puget Sound Health Care System in the fall of 2020. Our review of VA progress data shows that VA met the schedule for making EHR system configuration decisions it had established, which required VA’s 18 EHR councils to make at least 70 percent of decisions needed for capability set 1 by October 18, 2019. An EHRM program official stated that this threshold was required to enable Cerner to configure the EHR system for the Mann-Grandstaff VA Medical Center in anticipation of the system’s initial implementation. According to VA’s progress data, collectively, the 18 EHR councils met the requirement to make at least 70 percent of their total expected EHR system configuration decisions for capability set 1. Specifically, as of early November 2019, VA data for EHR configuration decisions needed for capability set 1 indicated that the EHRM program had developed: 877 of 966 (or 91 percent) of workflows; 1,397 of 1,412 (or 99 percent) of design decision matrices; and 1,364 of 1,610 (or 90 percent) of data collection workbooks. After the EHR councils collectively met VA’s goal to make 70 percent of EHR system configuration decisions by October 18, 2019, efforts continued to make the remaining decisions for capability set 1. In March 2020, VA data indicated that, combined, the EHR councils had developed an additional: 9 percent of workflows—874 of 878 (or nearly 100 percent); 1 percent of design decision matrices—1,459 of 1,467 (or nearly 100 10 percent of data collection workbooks—1,746 of 1,751 (or nearly 100 percent). (See Appendix I for additional details on specific changes from November 2019 to March 2020 by EHR councils.) As noted earlier, though the workshop process has concluded, a VA EHRM program official stated that they had plans to hold virtual—over teleconference or videoconference—meetings to allow the EHR councils to make remaining EHR system configuration decisions for capability set 1 at the Mann-Grandstaff VA Medical Center, by March 2020. VA Has Formulated a Schedule for Capability Set 2 Configuration Decisions VA’s EHRM program has formulated a schedule for making EHR system configuration decisions for capability set 2, which are necessary to support the implementation of the Cerner EHR system at the VA Puget Sound Health Care System planned for the fall of 2020. Specifically, VA’s EHRM program is continuing to make EHR system configuration decisions outside of the workshop process, which concluded in October 2019. Currently, EHRM program officials have plans to hold smaller meetings, about a fourth of the size of the national workshops, to make EHR configuration decisions that require input from multiple councils for capability set 2. According to EHRM program officials, the program set a goal of developing capability set 2 workflows, design decision matrices, and data collection workbooks by May 2020 so that the EHR councils could start validating the system configuration decisions at that time. EHRM program officials anticipate that this schedule for capability set 2 gives Cerner enough time to configure the EHR system and establish a training environment to enable implementation of the EHR system at the VA Puget Sound Health Care System planned for the fall of 2020. According to program officials, capability set 2 is composed of about 90 percent of configuration decisions for capability set 1 and 10 percent of additional workflows and data collection workbooks. These officials also told us that, as part of the process of making capability set 2 configuration decisions, they would determine the effectiveness of these decisions based on the implementation of capability set 1 at the Mann-Grandstaff VA Medical Center and make any necessary changes. VA’s Decision-Making Procedures Were Generally Effective, but Key Stakeholders Were Not Always Included VA’s EHRM program established EHR council decision-making procedures that were generally effective. In addition, the councils included a wide range of stakeholders, in terms of geographic representation and representation from VA central office, VISNs, and medical facilities. However, according to EHR council participants, VA did not always ensure adequate representation at local workshops. VA’s EHRM Program’s Decision-Making Procedures for EHR Councils Were Generally Effective VA’s EHRM program’s decision-making procedures for the EHR councils were generally effective as demonstrated by adherence to applicable federal standards for internal control. According to these standards, management should establish an organizational structure, assign responsibility, and delegate authority to achieve the entity’s objectives. In addition, according to our leading collaboration practices, clarity can come from agencies working together to define and agree on their respective roles and responsibilities and participating agencies should document their agreement. VA’s EHRM program established the organizational structure, assigned responsibility, and delegated authority for system configuration decisions to the EHR councils. Specifically, the EHRM program developed a charter for the councils that outlined each council chair’s responsibility for managing council membership and ensuring it is consistent with guidelines for broad representation; outlined council member roles and responsibilities, such as participating in face-to-face meetings and conferences, providing subject matter expertise, and guiding EHR system configuration decisions; and delegated authority for EHR system configuration decisions from the EHRM Chief Medical Officer to the council chair and members. According to EHRM program documentation, VA established decision- making authority at the lowest level possible, beginning with the EHR councils, to ensure timely and appropriate decision-making. Based on our observations of national council workshop meetings, if a council had questions that involved coordination with another council, the Cerner consultant present would take note of the issue and coordinate a meeting with the relevant councils to discuss the issue. For example, participants from the Ambulatory Council met with participants from the Rehabilitation and Acute Clinical Ancillaries Council to discuss the EHR system configuration decisions for ordering glasses and contacts. Based on our review of the Functional Governance Board charter and meeting minutes, when a decision required coordination and could not be made at the EHR council level, it was identified and escalated to the Functional Governance Board. The Functional Governance Board provided guidance on addressing issues or, in turn, escalated unresolved issues to the higher-level Governance Integration Board, or if appropriate, to a joint VA and DOD coordination process. According to EHRM program officials, as of February 2020, there were no issues escalated from the Functional Governance Board to the Governance Integration Board because the council governance structure strived to make decisions at the lowest level possible. Figure 5 provides an overview of the EHRM program’s decision-making procedures. With respect to collaboration, because VA is using the same system as DOD, VA has had to coordinate with DOD on some decisions. Although both departments have procedures for configuring the Cerner EHR system for their individual needs, VA EHRM program officials noted the importance of coordinating to design a system that would allow sharing of information and tasks between VA and DOD. According to VA EHRM program officials, for example, VA and DOD coordination is necessary for workflows pertaining to durable orders for life-sustaining treatments—medical treatments intended to prolong the life of a patient who would die soon without the treatment (e.g., artificial nutrition and hydration, and mechanical ventilation). VA and DOD’s practices differed on how to address such treatment, and Cerner’s process did not accommodate VA’s need to maintain durable orders across patient encounters, so they would not need to be re-written every time a patient changed care setting or location. VA requested changes to the Cerner EHR system to allow it to continue to follow its current process for documenting life-sustaining treatments, but according to DOD officials, the proposed changes did not align with DOD’s position on such treatments, specifically resuscitation statuses. After multiple discussions between the VA and DOD clinicians, the two departments plan to adopt an interim solution. According to VA and DOD officials, VA and DOD’s joint decision-making body, the Functional Decision Group, has met weekly to address coordination issues since early 2019. These officials said that the joint Functional Decision Group determined whether it could make a decision, or whether additional information was needed and a team should be established to work on dispute resolution between the departments. VA EHRM program officials said that the coordination procedures for the joint Functional Decision Group would be formalized and that the roles and responsibilities for coordination between VA and DOD would be clearly defined, in response to a recommendation we made in a previous report. Specifically, VA and DOD have developed a charter for the joint Functional Decision Group, which was signed in April 2020. According to EHR council participants, VA and DOD had been developing their coordination procedures as system configuration decisions were made, and decisions that required input from both departments may not have been as timely as they could have been. According to EHRM program officials, the departments ultimately were able to address most decisions and coordination on remaining decisions was ongoing as of March 2020. VA’s EHRM Program Included a Wide Range of Participants at National and Local Workshops, but Did Not Always Ensure the Involvement of Key Stakeholders VA’s EHRM Program Largely Met EHR Council Charter Goals for Representation VA generally included a wide range of stakeholders in its 18 EHR councils. Specifically, VA was largely in line with its EHR councils’ charter goals to include about 60 percent of council members from the field, with the remainder from the central office, and to have representatives from a range of geographic locations and with sufficient experience and expertise: VA data show that EHR councils had about 58 percent (607 of 1,039) of its members representing the field and about 40 percent (415 of 1,039) representing VA’s central office, roughly in line with VA’s goals. The councils included participants from a variety of geographic regions, including each of its 18 VISNs, with the most participants representing VISN 20, which oversees the two medical facilities where the new EHR system is scheduled to be initially implemented. Participants primarily represented the most complex level of VA medical facilities. Specifically, VA data show that about 83 percent (861 of 1,039) of participants represented level 1 VA medical facilities, whereas about 3 percent (33 of 1,039) and 7 percent (75 of 1,039) represented medium (level 2) and low (level 3) complexity VA medical facilities, respectively. EHRM program officials said that the majority of participants represented higher-complexity facilities because participants were drawn from national experts and published authors, and often performed VA-specific processes. Furthermore, smaller medical centers had fewer resources so clinicians were more likely to be needed to continue providing patient care at those facilities and less likely to be available to serve on councils. According to a voluntary questionnaire VA asked council participants to complete, about 37 percent of the 304 participants who completed the survey had at least 6 years of experience at VA; 29 percent had at least 16 years of experience; and, 19 percent had more than 25 years of experience. In addition to participants from the VA, we observed that EHR council national workshop meetings included participants from outside of the department—such as clinicians from DOD sites and commercial health care systems that had already implemented Cerner’s EHR system. These participants provided support for discussions and insight into industry best practices. While the EHR councils included a wide range of participants, in September and October 2019, council participants from both of the initial operating capability sites raised concerns that the councils did not include adequate representation from specialty areas at national workshop meetings. Specifically, these officials said that an insufficient number of specialty physicians, including pulmonologists and gastroenterologists, were included. In addition, VA’s summary from the last workshop, national workshop 8, observed that additional subject matter experts representing medical specialties should be included in the EHR system configuration decision process to enhance collaboration and decision- making. EHRM program officials, including the Chief Medical Officer and Ambulatory Council chairs, said they had not included certain specialists and scheduled workshops on specialty areas, such as pulmonology and gastroenterology as they decided to focus first on more foundational decisions, such as those for primary care. Starting in November 2019, following the completion of the eight national workshops, VA EHR councils continued to meet, as necessary, to complete capability set 1 and 2 configuration decisions and had begun to include clinicians from specialty areas in these meetings. VA plans to continue these meetings through September 2020. VA’s approach of including clinicians from specialty areas in ongoing configuration decision meetings is generally consistent with our leading collaboration practice that agencies should ensure that all relevant participants be included in any collaborative effort they undertake. By including relevant participants, the program increases the likelihood that it has considered input from participants with unique knowledge, skills, and abilities. Further, including relevant participants increases the likelihood that when implemented, the EHR system will be properly configured to meet the needs of clinicians, and effectively support their efforts to deliver care. VA’s EHRM Program Did Not Always Include Key Stakeholders at Its Local Workshops Local workshops at the Mann-Grandstaff VA Medical Center and VA Puget Sound Health Care System did not always include representation from relevant stakeholders, including facility clinicians and staff. Specifically, multiple participants in the local workshop meetings, including clinicians and department leads, at these facilities said that VA’s EHRM program did not always effectively communicate information about local workshop meetings to facility clinicians and staff to facilitate the designation of staff to participate and ensure relevant representation at local workshops. Local workshop participants stated that they did not always know which local workshop meetings they needed to attend, because they did not receive adequate information about the session topics. This is inconsistent with key collaboration practices identified in our prior work to ensure that relevant participants be included in any collaborative effort and that participating entities have agreed on common terminology. Furthermore, standards for internal control in the federal government call for effective communication and information sharing. Local workshop participants, including clinicians and department leads from medical facilities said that differences in the use of terminology between VA and Cerner sometimes made it challenging to identify the clinicians and staff that should attend local workshop meetings. For example, some officials reported that they did not believe that a meeting on “charge services” would be relevant to their work given that VA does not typically bill veterans for services. However, they later learned that the meeting actually covered topics beyond billing, such as capturing workload data that was relevant to their work. Because Cerner and VA did not always effectively communicate regarding workshop content for local workshops, local workshops did not always include all relevant stakeholders. As previously stated, VA plans to hold local workshops in advance of the Cerner EHR system implementation at future VA medical facilities. However, VA has not indicated how it will improve the ways in which it describes the topics of these workshops, including providing sufficient detail and defining key terms. If VA improves communication on workshop meeting topics, the EHRM program can increase the likelihood that it will obtain appropriate input from facility clinicians and staff at local workshops to consider in design decisions for the implementation of the EHR system. Conclusions VA met its schedule for making the needed system configuration decisions that would enable the department to implement its new EHR system at the first VA medical facility, which was planned for July 2020. In addition, VA has formulated a schedule for making the remaining EHR system configuration decisions before implementing the system at additional facilities planned for fall 2020. VA’s EHRM program was generally effective in establishing decision- making procedures that were consistent with applicable federal standards for internal control. However, VA did not always ensure the involvement of relevant stakeholders, including medical facility clinicians and staff, in the system configuration decisions. Specifically, VA did not always clarify terminology and include adequate detail in descriptions of local workshop sessions to medical facility clinicians and staff to ensure relevant representation at local workshop meetings. Participation of such stakeholders is critical to ensuring that the EHR system is configured to meet the needs of clinicians and support the delivery of clinical care. Recommendation for Executive Action We are making the following recommendation to VA: For implementation of the EHR system at future VA medical facilities, we recommend that the Secretary of VA direct the EHRM Executive Director to clarify terminology and include adequate detail in descriptions of local workshop sessions to facilitate the participation of all relevant stakeholders including medical facility clinicians and staff. (Recommendation 1) Agency Comments We provided a draft of this report to VA and DOD for comment. In its comments, reproduced in appendix II, VA concurred with our recommendation and described steps that it planned to take to address it. Specifically, VA noted that it planned and designed its workshops to enable collaboration between clinical and administrative experts and end- users so that the EHR system is designed, validated, and configured to promote interoperability and quality care for veterans. VA stated that it is further refining local workshop agendas and descriptions to facilitate VA subject matter expert identification and participation. VA also provided technical comments on the report, which we incorporated as appropriate. DOD provided technical comments on the report, which we incorporated as appropriate. We are sending copies of this report to the appropriate congressional committees, the Secretaries of VA and DOD, and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staffs have any questions about this report, please contact Debra A. Draper at (202) 512-7114 or DraperD@gao.gov or Carol C. Harris at (202) 512-4456 or HarrisCC@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix III. Appendix I: Status of Electronic Health Record System Configuration Decisions, as of November 2019 and March 2020 Data collection workbooks. All EHR councils completed at least 80 percent of expected data collection workbooks. Specifically, by November 2019, three of the 18 councils completed 100 percent of them and by March 2020, each of the councils had completed 100 percent of their data collection workbooks. Table 3 shows the number of data collection workbooks completed in comparison to the total expected for each of the 18 EHR councils based on data from November 13, 2019 and March 26, 2020. Appendix III: GAO Contact and Staff Acknowledgments GAO Contact Staff Acknowledgments In addition to the individuals named above, Mark Bird (Assistant Director), Michael Zose (Assistant Director), Merry Woo (Analyst-in-Charge), Bianca Eugene, and Paris Hawkins made key contributions to this report. Also contributing were Jennie F. Apter, Giselle Hicks, Monica Perez- Nelson, and Ethiene Salgado-Rodriguez.


Background VHA recommends that all veterans who receive VHA services be screened for HIV as part of routine medical care, including those who do not think they are at risk for acquiring the virus. The aim is to ensure that veterans who are infected with the virus can be diagnosed as early as possible, receive life-saving care, and avoid passing the virus on to others. VHA has made earlier diagnosis of HIV a priority for the agency and established certain requirements for VAMC providers that aim to achieve early diagnoses and rapid linkages to HIV care for veterans. HIV screening at VAMCs involves three stages, and related VHA policy sets forth providers’ requirements related to each of these stages. (See fig 1.) Stage one: providing HIV tests to consenting veterans. A provider in a primary care clinic, a specialty care setting (such as an infectious disease clinic), or other outpatient setting (such as a women’s health clinic) offers a voluntary HIV test to an eligible veteran. In accordance with Centers for Disease Control and Prevention (CDC) recommendations, VHA policy requires providers to offer a one-time test to all veterans; annual tests to veterans with known higher risk factors for acquiring the virus, such as injection drug use; and tests every 3 months to veterans with known higher risk factors who are prescribed preventive medication known as pre-exposure prophylaxis (PrEP). Once a provider obtains consent from the veteran to be tested for HIV, the provider initiates an HIV test order with the laboratory. Although VHA policy previously required that providers document that they obtained veterans’ verbal consent to be tested for HIV, as of April 2019, providers must obtain, but no longer need to document, such consent. In addition, under VHA policy, providers must order the most current CDC- recommended HIV test (which detects HIV antigens and antibodies) when clinically indicated, and laboratories must follow the CDC-recommended HIV testing algorithm (see text box). A blood sample is collected from the veteran, and the laboratory processes the HIV test. Information Technology Solutions and Contacting Veterans As Needed Are Among the Approaches That Selected VAMCs Use to Facilitate HIV Screening Officials from Selected VAMCs Reported Using Information Technology Solutions, Such as Clinical Reminders, to Facilitate the Provision of HIV Tests for the First Stage of Screening Officials from the five selected VAMCs reported using information technology solutions and other strategies to facilitate each of the three stages of HIV screening: providing HIV tests to consenting veterans (stage one), communicating HIV test results to veterans (stage two), and linking HIV-positive veterans to care (stage three). Officials from multiple VAMCs in our review stated their providers use information technology solutions, such as clinical reminders, to fulfill their requirements related to the first stage of HIV screening: offering HIV tests to veterans, obtaining veterans’ verbal consent to be tested, and ordering the most current recommended HIV test. Offering HIV tests to veterans. Officials from three VAMCs in our review told us that providers often use clinical reminders that were developed and implemented by the VAMC or associated VISN to prompt them to offer HIV tests to veterans. (See fig. 2.) According to these officials, clinical reminders are used to prompt providers to offer a one-time HIV test to veterans who have not been tested. They can also be used to facilitate providers’ identification of veterans who are at higher risk for acquiring HIV and subsequently prompt them to offer these veterans an HIV test on an annual, rather than a one-time, basis. For example, officials at two of these three VAMCs indicated that the reminders include prompts for determining if veterans are at higher risk of acquiring HIV or fields to document identified risk factors. One of these officials told us that the recurrence of these clinical reminders can subsequently be increased or decreased to prompt providers to offer an HIV test to veterans who are at higher risk of acquiring HIV on a more or less frequent basis, depending on the risk factors identified over time. Obtaining veterans’ verbal consent to be tested. According to officials from the three VAMCs that discussed the use of clinical reminders, this technology prompts providers to obtain veterans’ verbal consent to be tested for HIV before ordering tests. Further, the reminders give providers a way to document that consent was obtained. For example, officials at one of the three VAMCs stated that providers can access the laboratory menu, which they use to order an HIV test, through the clinical reminder. The officials stated that providers must either (a) document that they obtained veterans’ verbal consent within the clinical reminder before accessing the menu, or (b) document that verbal consent was obtained once they have accessed the menu. Ordering recommended HIV tests. Officials from four of the VAMCs in our review reported that the facilities’ laboratory menus are designed to make it easier for providers to order the most current CDC-recommended HIV test. For example, officials from two VAMCs told us that the most current CDC-recommended HIV test is either the first result that appears when searching for an HIV test within the laboratory menu or the first HIV test that appears within a list of different types of HIV tests. According to officials from another VAMC, the facility’s laboratory menu includes a prompt that explains that an HIV viral load test (a test that is primarily used to monitor an active HIV infection) is not recommended solely to be used for diagnostic purposes if a provider attempts to order such a test for this purpose. Officials from Selected VAMCs Reported Contacting Veterans to Schedule Non-Routine Appointments to Communicate Positive HIV Test Results for the Second Stage of Screening Officials at each of the five VAMCs in our review told us that staff contact veterans to schedule non-routine, in-person appointments within the 7 day time frame to inform them that they have tested positive for HIV. According to officials at four VAMCs, staff first place phone calls to veterans and request that the veterans schedule face-to-face visits with providers. Officials at two VAMCs explained that providers attempt to inform veterans of positive HIV test results in person given the sensitive nature of the diagnosis, as recommended by VHA policy. If staff cannot reach the veterans by phone, officials at these two VAMCs indicated that they send letters to the veterans asking them to contact their providers to obtain their test results. Further, officials at three VAMCs stated that staff send letters to veterans to inform them of negative HIV test results within the required 14 day time frame. Officials from all five VAMCs in our review also reported using various, additional approaches to communicating negative HIV test results to veterans, including notifying them by phone, informing them of test results during face-to-face visits, or uploading test results into veterans’ personal electronic health records (EHR). In addition, all five VAMCs in our review have developed protocols to prevent delays in the communication of positive HIV test results to veterans when the provider who ordered the test is unavailable. These protocols are generally outlined in facility-specific policies, which we reviewed, that require that a designee communicate positive HIV test results to veterans in lieu of the ordering provider. According to officials at three VAMCs, these protocols apply when the ordering provider is unavailable for a certain number of consecutive days (typically 3 days). Officials told us that if the designee is not available, their facility’s protocol requires that VAMC leadership (such as the Chief of Medicine) communicate the results to the veteran. Officials from Selected VAMCs Use Referrals to Community Providers and Telecommunications to Link Veterans Newly Diagnosed with HIV to Care for the Third Stage of Screening Officials from all five VAMCs in our review indicated that providers may refer eligible HIV-positive veterans to care within the community to ensure that treatment occurs in a timely manner. According to officials at two of these VAMCs, these referrals are often made based upon veterans’ preferences or primary care providers’ comfort levels in providing HIV care to veterans who are also eligible for community care. An official at another of these VAMCs told us that eligible veterans who live further distances from the VAMC may ask to be referred to community care. According to officials from multiple VAMCs in our review, providers may also use telecommunications to provide HIV care to veterans. For example, officials from two VAMCs told us that their facilities offer telehealth consultations with an infectious disease provider to veterans who live outside the city in which the VAMC is located or who otherwise find it inconvenient to be seen in-person by an infectious disease provider at the facility. Telehealth allows infectious disease providers to care for veterans who would otherwise receive HIV care from primary care providers or in the community. Officials at another VAMC reported that infectious disease providers are available via cell phone or Skype (software that can be used to make one-to-one or group voice or video- based calls from a cell phone or computer) to assist primary care providers who assume responsibility for veterans’ HIV care. VHA Facilitates Monitoring of the Provision of HIV Tests, but Has Not Completed All Steps to Enable Monitoring of Subsequent Stages of HIV Screening VHA Collects and Disseminates Data for VAMCs to Use to Monitor the Offering of HIV Tests to Veterans VHA facilitates monitoring of the first stage of HIV screening by providing information to VAMCs that include data on the number of veterans who have been tested for the viral infection. While VHA does not collect data on the timeliness with which HIV test results are communicated to veterans, data resulting from VHA’s monitoring of the communication of other test results may indicate whether veterans are informed of HIV test results within recommended time frames. However, HIV lead clinicians may not be aware that they have access to this information. VHA does not currently monitor whether veterans who test positive for HIV are linked to care within recommended time frames; however, VHA has taken steps to collect and disseminate data that can be used to monitor this stage of screening. According to HHRC officials, the office collects and disseminates annual and biannual data to each VAMC’s HIV lead clinician on the offering of HIV tests to veterans. (See table 2 for information related to VHA’s monitoring activities.) This includes data on (1) the number of veterans who are eligible to receive one-time HIV tests, as well as the number of eligible veterans who were tested, for each VAMC and VISN; and (2) the number of veterans who are prescribed PrEP who are tested for HIV every 3 months to document that they are still HIV negative as recommended by the CDC. HHRC officials told us that they share the one-time testing rate data with HIV lead clinicians on an annual basis, and that these clinicians can use the data to calculate their VAMCs’ one- time HIV test rates and, subsequently, compare their rates regionally or to VAMCs that offer the same complexity of services. According to HHRC officials, they upload these data to an internal data sharing website and notify HIV lead clinicians that the data are available via email and during regularly scheduled conference calls that facilitate the discussion of issues related to HIV screening. HHRC officials also told us that VHA uses the same method to share with HIV lead clinicians on a biannual basis data on the HIV test rate for veterans who are prescribed PrEP. VISNs and VAMCs have used VHA’s data on the offering of HIV tests to veterans to support local efforts to improve HIV screening. For example, HHRC officials told us that VISNs have used data on the number of veterans who are eligible to receive one-time HIV tests, and who were tested, to support applications for VHA-sponsored grants intended to improve the offering of such tests to homeless veterans. Officials from four VAMCs in our review told us that they have used these data to identify the need to increase testing, which led to the implementation of new strategies, such as clinical reminders that prompt providers to offer one-time and risk-based HIV tests to veterans. While VHA recently monitored the documentation of verbal consent by collecting data that VAMCs used to make related improvements, such monitoring is no longer needed due to a change in VHA policy. Between fiscal years 2013 and 2016, NCEHC (the VHA office responsible for VHA’s policy on informed consent) oversaw a system-wide review that led to improvements in the number of VAMC providers that documented in veterans’ medical records that they obtained veterans’ verbal consent to be tested for HIV. In 2019, VHA amended its policy and no longer requires providers to document that they obtained verbal consent. In addition, VHA recently monitored VAMC laboratory protocols for HIV testing, but HHRC noted that this monitoring is no longer needed, because the recommended testing technologies have been implemented. In 2018, VHA conducted a one-time review of VAMC laboratory protocols to ensure that CDC recommendations for the use of HIV tests were followed at each VAMC, such as recommendations related to the type of HIV test that providers should order for diagnostic purposes. VAMCs were required to submit verification to VHA showing that their laboratories had implemented the most current CDC-recommended testing technologies. According to HHRC officials, this provided assurance that providers were ordering the most current CDC-recommended HIV test and that laboratories were following the CDC-recommended HIV testing algorithm. VHA’s Director of Pathology and Laboratory Medicine Service reviewed the verification submitted by each VAMC, and VAMCs were required to develop action plans to address any identified deficiencies. As of August 7, 2018, VHA found that all VAMCs were following CDC’s recommendations related to the availability and use of HIV tests. According to HHRC officials, VHA does not need to continue its monitoring effort in this area, since the implementation of recommended testing technologies by VAMCs was a one-time effort. Further, officials from the five VAMCs in our review told us that the VAMCs were using the CDC-recommended HIV test, and nothing inconsistent came to our attention during our medical records review. VHA Makes Data on the Timeliness of Communicating Test Results Available, but Has Not Ensured that VAMC Staff Are Aware They Have Access to It OPC and RAPID (the VHA offices responsible for VHA’s policy on the communication of test results and related performance measurement) make data available to VAMC staff that may indicate the timeliness with which HIV test results are communicated to veterans. OPC and RAPID publish a quarterly report on the timeliness with which results from the eight tests that are included in its review of veterans’ medical records are communicated to veterans at each VAMC. While HIV tests are not one of the eight tests included in the OPC and RAPID review, VAMC officials we interviewed told us that VAMC procedures for communicating results are generally the same for all tests. OPC officials stated that VAMC officials could use the data to identify needed performance improvement efforts related to the communication of test results. OPC officials added that while it is not the primary goal of the OPC and RAPID review, data on the eight tests included in the review may serve as a sample, providing some indication as to whether VAMC procedures promote the timely communication of results of any test to veterans. Although OPC and RAPID publish a quarterly report on the timeliness of communicating test results, HIV lead clinicians may not be aware they have access to this information. OPC and RAPID officials told us that VAMC staff responsible for serving as liaisons for OPC’s medical records review are notified by RAPID via email of the report’s availability. RAPID officials added that any VAMC staff may opt in to the email group that officials use to notify liaisons that the timeliness data have been published. HIV lead clinicians we interviewed reported that they did not know that they can opt in to this email group. According to RAPID officials, the main mechanism for making VAMC staff aware that they can join this email group is through their VAMC colleagues. VHA has not taken steps to more systematically communicate the availability of these timeliness data to all VAMC staff (including HIV lead clinicians). Standards for internal control in the federal government require that agencies communicate necessary information throughout all agency reporting lines to achieve the agencies’ objectives and respond to identified risk. VHA policy requires that HIV lead clinicians serve as VAMC points of contact on HIV testing, diagnosis, and care, which may include monitoring HIV care. An HIV lead clinician we interviewed also noted that these data could be used as an indicator as to whether HIV test results are being communicated to veterans in a timely manner. Further, having these data could help staff determine if delays in communicating test results pose risks to the timely completion of HIV screening, such as whether veterans who test positive for HIV are linked to care for their diagnosis as expeditiously as possible. If there are unnecessary delays in communicating positive HIV test results to veterans, providers may be at risk of delaying the start of needed HIV treatment. According to VHA policy, and confirmed by RAPID officials, the timely communication of test results to veterans is essential for high quality care, and the timely follow- up of positive test results may help veterans achieve favorable health outcomes. VHA Does Not Collect or Disseminate Data to Monitor VAMCs’ Timeliness in Linking Veterans Who Test Positive for HIV to Care, but Has Taken Steps to Do So Linking Veterans to Preventive Care for Human Immunodeficiency Virus (HIV) In addition to linking veterans who test positive for HIV to care for their diagnosis, Department of Veterans Affairs (VA) medical centers link veterans who test negative for HIV to preventive care. The use of preventive medication, or pre-exposure prophylaxis (PrEP), reduces the risk of acquiring HIV in adults. Officials from VA’s HIV, Hepatitis, and Related Conditions Programs (HHRC) told us that they implemented a PrEP quality improvement initiative in September 2016, which focuses on increasing the use of PrEP among veterans who live in areas of the country with a higher prevalence of HIV compared to the national average. HHRC officials told us that the initiative focuses on providing high quality care to veterans in accordance with current recommendations on the use of PrEP. For example, the Centers for Disease Control and Prevention (CDC) has recommended that providers prescribe PrEP medications to individuals who test negative for HIV within one week of documenting the test result. HHRC officials told us that they monitor the time frames in which veterans are prescribed PrEP medication by collecting data on a biannual basis on the date on which veterans’ blood was drawn for the purposes of conducting an HIV test and the date on which veterans’ were prescribed the medication. HHRC officials told us that these data are disseminated to VA medical center staff responsible for improving HIV screening to improve the appropriate use of PrEP as needed. source of information to determine whether veterans are linked to care specifically for their HIV diagnosis within the recommended time frame. According to officials, the data tool was implemented in October 2018, and as of early November 2019, they were in the process of building the capacity to generate a report based on these data showing the time frames in which veterans are linked to HIV care. HHRC officials initially indicated that they expected to begin monitoring linkage to HIV care in August or September 2019, but they were not able to do so for various reasons. According to HHRC officials, the process of building the new data tool and the capacity to generate a report has been lengthy due to competing priorities related to VHA’s ongoing development of a new EHR system. These officials added that they have been simultaneously focused on implementing required improvements in the diagnosis and treatment of veterans with Hepatitis C. According to officials, the time frame to develop the new data tool and report has been extended due to these competing priorities. HHRC officials told us that once monitoring begins, they will report on the number of veterans who are linked to HIV care within the recommended 30-day time frame for each VAMC on an annual basis, retroactive to fiscal year 2018. According to HHRC officials, the data will be disseminated by publishing them on an internal data sharing website that each VAMC’s HIV lead clinician can access. The officials explained that these clinicians will be notified when the data have been published via email and during regularly scheduled conference calls with HHRC. HHRC officials also told us that the data may be used to inform any needed improvements in the timeliness of linking newly diagnosed veterans to HIV care. Standards for internal control in the federal government require that agencies perform ongoing monitoring activities and evaluate results to remediate any identified deficiencies on a timely basis. VHA policy requires that HHRC develop data reports for monitoring the quality of HIV care that are to be disseminated to the VISNs or VAMCs, among other entities and individuals, and lead VHA efforts toward meeting the NHAS’s recommendations. However, until HHRC disseminates data on the timeliness with which veterans are linked to HIV care, VAMCs are limited in their ability to identify any delays and take the necessary steps to ensure that this occurs within recommended time frames, now and in the future. In our nongeneralizable review of the 38 medical records for veterans who tested positive for HIV, we observed some instances of delay. Specifically, we found that six veterans were first seen by an infectious disease provider, who typically treats HIV, more than 30 days after being informed of their positive test results. We were unable to identify a documented explanation in the six medical records for why linkages to care exceeded 30 days. Delays in linking veterans to HIV care can increase the risk that veterans are not promptly beginning treatment to help achieve favorable health outcomes. According to the 2015 NHAS, evidence shows that earlier treatment reduces the risk that an individual with HIV will develop AIDS or transmit the virus to others. Conclusions Veterans who are voluntarily tested for HIV at VAMCs, informed of positive HIV test results in a timely manner, and expeditiously linked to care before their infections progress further have improved health outcomes, a longer life expectancy, and a reduced risk of transmitting the virus to, for example, a sexual partner. VHA has monitored the provision of HIV tests to veterans and reported related improvements resulting from these monitoring efforts, ensuring that, for example, veterans are receiving the most current CDC-recommended test. However, VHA’s dissemination of data on the time frames in which test results are communicated to veterans and monitoring of the time frames in which HIV-positive veterans are linked to care specific to their diagnosis needs improvement. Recommendations for Executive Action We are making the following two recommendations to VA: The Under Secretary for Health should take steps to improve communication to VAMC staff (including HIV lead clinicians) about the availability of data on the time frames in which test results are communicated to veterans. (Recommendation 1) The Under Secretary for Health should disseminate data to HIV lead clinicians on the extent to which veterans who test positive for HIV are linked to care within recommended time frames. (Recommendation 2) Agency Comments We provided a draft of this report to VA for review and comment. In its written comments, which are reproduced in appendix I, VA concurred with our recommendations. VA stated that it will communicate to VAMC staff, including HIV lead clinicians, how providers may be notified when the data on the time frames in which test results are communicated to veterans have been published. Further, VA stated that HIV test results will be added to the OPC and RAPID quarterly review of such time frames beginning in the second quarter of fiscal year 2020. VA also indicated that as of December 2019, the agency began annual monitoring of whether veterans are linked to HIV care within recommended time frames and will notify HIV lead clinicians of the availability of the data during conference calls scheduled to take place in January and March 2020. We are sending copies of this report to the appropriate congressional committees and the Secretary of Veterans Affairs. In addition, this report is available at no charge on the GAO website at https://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or at DraperD@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix II. Appendix I: Comments from the Department of Veterans Affairs Appendix II: GAO Contact and Staff Acknowledgments GAO Contact Staff Acknowledgments In addition to the contact named above, Hernán Bozzolo (Assistant Director), Karen Belli (Analyst-in-Charge), Hannah Grow, Cathy Hamann, and Tatyana Walker made key contributions to this report. Also contributing were Jacquelyn Hamilton, Diona Martyn, and Vikki Porter.