IHS was established within the Public Health Service in 1955 to provide health services to members of AI/AN tribes primarily in rural areas on or near reservations. IHS provides these services directly through a network of hospitals, clinics, and health stations operated by IHS, and it also funds services provided at tribally operated IHS facilities. The federally operated system comprises 26 hospitals, 56 health centers, and 32 health stations in 33 states and received over 5 million outpatient visits and approximately 19,000 admissions in 2014. (See table 1.) Federally operated IHS hospitals range in size from 4 to 133 beds and are open 24 hours a day for emergency care needs. Health centers offer a range of care, including primary care services and at least some ancillary services, such as pharmacy, laboratory, and X-ray services, and they are open for at least 40 hours a week. Health stations offer only primary care services on a regularly scheduled basis and are open fewer than 40 hours a week. IHS oversees its health care facilities through a decentralized system of area offices, which are led by area directors and located in 12 geographic areas. (See fig. 1 for a U.S. map showing the IHS patient population by area). Nine of these 12 IHS areas have federally operated IHS facilities-- Albuquerque, Bemidji, Billings, Great Plains, Nashville, Navajo, Oklahoma City, Phoenix, and Portland. According to IHS, the headquarters office is responsible for setting health care policy, ensuring the delivery of quality comprehensive health services, and advocating for the health needs and concerns of AI/AN people. The IHS area offices are responsible for distributing funds to the facilities in their areas, monitoring their operation, and providing guidance and technical assistance. (See fig. 2). According to IHS, its mission to raise the physical, mental, social, and spiritual health of AI/AN people to the highest level cascades through every organizational level and individual in the agency. This cascading method of accountability is often used by health care organizations with a decentralized management structure and is recommended by the Office of Personnel Management (OPM) for agencies with clear organizational goals and objectives. In addition, in 2009 IHS developed four agency- wide priorities that serve as a strategic framework for improvement within the agency. One of these four priorities is to improve the quality of and access to care. In 2016, IHS established the following revised agency-wide priorities: assess care, improve delivery of services, address behavioral health issues, strengthen management, bring health care quality expertise to IHS, and engage local resources. IHS's oversight of the quality of care provided in its federally operated facilities has been limited and inconsistent. While some oversight functions are performed at the headquarters level, the agency has delegated primary responsibility for the oversight of the quality of care to the area offices. Area officials told us that the oversight they provide has generally included (1) holding periodic meetings with facility staff, such as governing board and other meetings; (2) reviewing available quality performance data; (3) reviewing data on adverse events occurring in their facilities; (4) monitoring compliance with facility certification and accreditation requirements; and (5) appraising employee performance. However, our review found that this oversight was limited and inconsistent across IHS areas and facilities, in part due to a lack of agency-wide quality performance standards and significant leadership turnover in some offices. Meeting with facility staff. Officials from all nine of the area offices that oversee federally operated IHS facilities told us that they monitor the quality of care provided by facilities through periodic meetings with facility staff--including governing board meetings and other meetings. However, according to area office officials, the frequency of these meetings varies widely by area. In general, these meetings are used to discuss a range of issues, such as quality of care, equipment problems, staff vacancies, and provider credentialing. For example, documentation of a governing board meeting with facility staff in the Phoenix area shows that board members and staff discussed a problem with the facility's wireless internet connection, which was negatively affecting their bar code medication administration (BCMA) system. A board member noted that these connectivity issues caused a patient safety risk, but another board member noted that they had a short-term resolution in place and area office officials were working with the wireless carrier to resolve the problem over the long- term. Area offices vary, however, as to whether, or to what extent, these meetings focus on the quality of care. For example, officials from one area office stated that their governing board meetings include a standardized agenda that includes quality of care items, and that facilities are required to submit data reports that include information on quality issues such as rates of hospital acquired infections, patient complaints, and provider productivity. In contrast, officials from another area office told us that there are no standing agenda items for the discussion of quality of care, and that facility staff set the meeting agendas based on issues they want to discuss. Furthermore, the frequency of governing board meetings with facility staff varied widely among the area offices, ranging from quarterly to annually. Reviewing available quality performance data. According to IHS officials, clinical quality performance data are generally collected and reported consistently to IHS's area and headquarters offices in response to requirements in the Government Performance and Results Act of 1993 (GPRA), but other data used to oversee the quality of care provided in facilities are not reported or reviewed consistently across IHS. Officials from all nine area offices in our review stated that they periodically review reports showing facility progress in meeting 24 annual GPRA clinical performance measure targets. These performance measures focus on health screening and prevention activities, such as cancer screening, immunization rates, and tobacco cessation activities, and do not include broader measures of quality, such as whether patients are receiving proper diagnoses and medications, and the extent to which facility staff properly perform infection control activities. Area officials reported that they review other quality performance data, such as the percentage of medication orders reviewed for therapeutic duplication, the number of mislabeled laboratory specimens, and patient satisfaction, but these data are not consistently obtained or reviewed by all area offices because IHS has not required that they be reviewed or reported. In addition, staff from the two facilities in our review told us that limitations of IHS's electronic health record system--the Resource and Patient Management System (RPMS)--also contribute to variation in the quality performance data that are collected and reported to area offices. For example, staff told us that certain data elements, such as patient diagnoses, are difficult to extract from RPMS. Officials from facilities and area offices said that pulling these data may require special modifications to RPMS. Officials said that modifying RPMS requires knowledge of computer programming and can be costly, so some facility staff may manually enter and extract certain data. Officials from several areas also told us that some facilities have hired contractors or purchased software to assist them in monitoring their data. One such software package--QlikView-- provides facility staff with multiple data reporting options. Staff from one facility said that, from an information technology standpoint, they face "massively complicated issues" when the lack of a standardized user interface leads to individual facilities across IHS customizing RPMS for their own needs. IHS officials told us that they are working on improving RPMS, in part, by developing software to stabilize the system; however, we have not assessed these efforts. Monitoring adverse events. Officials from all nine area offices told us that their oversight of the quality of care includes monitoring adverse events that occur at IHS facilities, such as medication errors or patient falls, and taking steps to prevent future adverse events. While all IHS facilities have the means to report and monitor adverse events through an IHS-wide web-based reporting tool--WebCident-- officials told us reporting adverse events through WebCident has been inconsistent. Officials from one area office stated that adverse events are not always reported through WebCident, and therefore the appropriate staff are often not notified when adverse events occur, including those resulting in patient harm. These officials stated that this creates a lost opportunity to address the deficiency and improve, as well as to hold individuals accountable. Officials from IHS headquarters reported that they plan to enhance this reporting system to encourage consistent use by facility staff, or replace it with a new system after January 2017. Monitoring compliance with facility certification and accreditation requirements. Officials from all nine area offices in our review told us that they monitor the ongoing compliance with certification and accreditation requirements of the facilities in their area--such as through mock surveys and other interim monitoring--to help ensure that they maintain their certification by CMS to participate in the Medicare and Medicaid programs, as well as their accreditation by accrediting bodies such as The Joint Commission and the Accreditation Association for Ambulatory Health Care (AAAHC). For example, documentation of a mock survey of a facility in the Phoenix area states that the facility emergency department was improperly storing contaminated medical instruments. In addition, documentation of a mock survey of a facility in the Albuquerque area states that the surveyors found defective lead aprons, as well as a high-voltage power line sitting on the floor instead of behind a wall, and exposed electrical wiring blocking the door and wrapped around a door handle--which the surveyors concluded could be a serious hazard. These findings underscore the need for such surveys, but the frequency with which these mock surveys have been conducted varies by area. Officials from one area office told us that they have conducted mock accreditation surveys of facilities in their area annually for the past 15 years. Officials from other area offices stated that they have recently begun performing such mock surveys. IHS officials told us that in May 2016, IHS began a system-wide mock survey initiative at all 26 federally operated hospitals to assess compliance with the CMS Conditions of Participation and readiness for reaccreditation. Surveys conducted by CMS and accrediting bodies are relatively infrequent, however, and this infrequency highlights the importance of interim monitoring. For instance, area office staff told us that The Joint Commission conducts site visits every 3 years, and, while CMS attempts to conduct site visits every 3 to 4 years, staff of one facility we visited stated that CMS had not surveyed the facility in 10 years. Appraising employee performance. According to IHS, area directors are held accountable for achieving agency-wide goals and specific performance objectives through an appraisal process that also enables these goals and objectives to cascade down to chief executive officers (CEO) at individual facilities and to all agency employees. Area directors sign performance agreements documenting their accountability. The fiscal year 2016 performance requirements included a provision on ensuring that all IHS operated health care facilities achieve and maintain accreditation or certification by a national health care organization in fiscal year 2016. The performance requirements also included a provision on quality care that requires documentation of the implementation of "at least two activities to improve wait times and access to quality health care for patients that are based on enhanced implementation of current quality initiatives or new quality initiatives and that have measurable goals, measures and outcomes," as well as improvements resulting from these efforts. However, area officials can choose activities to satisfy this requirement from a list of suggestions--such as improving customer service and expanding clinic hours--without directly addressing the quality of care in their facilities. These inconsistencies are exacerbated by significant turnover in area leadership. Officials from four of the nine area offices in our review reported that they had at least three area directors in the past 5 years, and officials from three area offices reported that they had at least three chief medical officers. (See fig. 3 and 4). Officials stated that inconsistent area office and facility leadership is detrimental to the oversight of facility operations and the supervision of personnel. For example, officials from multiple area offices told us that frequent leadership turnover can lead to instability in oversight initiatives if these initiatives are started but not completed. In addition, an area office's review of a facility in the Navajo area documented that the majority of facility staff interviewed felt that there were too many people in acting leadership positions, that acting leaders were afraid to commit to decisions, and that the leaders needed additional supervisory training. In addition, the facility staff interviewed stated that those in acting leadership positions had their own work to contend with and were not always responsive to the responsibilities of the leadership position. According to IHS officials, the agency has not defined contingency or succession plans for the replacement of key personnel, including area directors. See appendix I for additional information on leadership turnover within IHS. IHS's limited and inconsistent agency-wide oversight of the quality of care in its federally operated facilities, as well as its lack of contingency and succession plans for key personnel, is inconsistent with federal internal control standards. These standards suggest that agencies should establish and review performance standards and then monitor data to assess the quality of performance over time, and that agencies should define contingency and succession plans for key roles to help continue achieving objectives. As a result of IHS's lack of consistent agency-wide quality performance standards, as well as the significant turnover in area leadership, IHS officials cannot ensure that facilities are providing quality health care to their patients, and therefore that the agency is making steps toward fulfilling its mission to raise the physical, mental, social, and spiritual health of AI/AN people to the highest level. Recognizing some of the challenges it faces with overseeing and providing quality health care in its facilities, IHS finalized the development of a quality framework in November 2016 that outlines, at a high level, IHS's vision, goals, and priorities to develop, implement, and sustain an effective quality program that is intended to improve patient experience and ensure the delivery of reliably high quality health care for IHS direct service facilities. According to IHS, the priorities of the framework are to (1) strengthen organizational capacity to improve quality of care and systems, (2) meet and maintain accreditation for federally operated facilities, (3) align service delivery processes to improve patient experience, (4) ensure patient safety, and (5) improve transparency and communication regarding patient safety and quality to IHS stakeholders. While this framework is focused on initiatives related to improving the quality of care provided in its facilities--such as increasing staff training and technical assistance on achieving compliance with quality and safety standards, promoting a culture of patient safety, and developing a patient perception survey process--elements of the framework also describe IHS plans to improve oversight. For example, the framework directs IHS to establish a quality office that will be responsible for assessing area office and facility functions, staffing, and critical quality assurance activities. This quality office is to be developed as part of an overall realignment of offices in IHS, and according to the framework, the office will be responsible for identifying resource needs, structures, processes, and supports for an effective and sustainable quality assessment and performance improvement system. More specifically, the framework directs IHS to develop a process for monitoring performance measures, such as measures of clinical care, patient access, and financial performance, for periodic review by leadership. In addition, IHS's quality framework states that the agency will implement annual mock accreditation surveys for all federally operated facilities and develop a standardized governing board structure to improve planning and oversight processes. The framework says that "transparency and accountability will be fostered through regular and frequent (i.e., monthly or quarterly) communications" between offices. The framework also explains that IHS will enhance its adverse event reporting system to encourage consistent use by facility staff, or replace it with a new system after January 2017. If effectively implemented, the quality framework could address the limited and inconsistent oversight of the quality of care provided in federally operated IHS facilities. However, as of November 2016, the quality office had not yet been formed, and officials told us the agency's plan for realigning offices was out for tribal review and comment. In addition, IHS officials stated that the agency has not yet selected quality performance measures but has plans to do so. Furthermore, the quality framework states that IHS will support enhanced efforts to recruit and retain highly qualified executives. While IHS officials reported that they are implementing strategies to recruit and retain staff, the quality framework does not specifically mention contingency or succession plans for key personnel. American Indians and Alaska Natives die at higher rates than other Americans from many causes--such as lower respiratory infections and complications from diabetes--that can be mitigated through access to quality health care services, and concerns continue to be raised about the quality of care provided in federally operated IHS facilities, including misdiagnoses, incorrectly prescribed medications, and unsafe facility conditions. Despite IHS's mission to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level, IHS's oversight of the quality of care in its federally operated facilities has been limited and inconsistent. In addition, several of the area offices in our review experienced frequent leadership turnover with no contingency or succession plans. While IHS has recognized the need for quality improvement and has drafted a quality framework to improve the oversight of the quality of care provided, it has not yet developed quality performance standards. Until IHS develops agency-wide standards for the quality of care provided in its federally operated facilities, systematically monitors facility performance in meeting these standards at all facilities, and develops contingency and succession plans for key personnel to address its significant leadership turnover, it cannot ensure that it is consistently providing quality medical care to the AI/AN population served in its facilities. To help ensure that quality care is provided to AI/AN people, the Secretary of HHS should direct the Director of IHS to take the following two actions: 1. As part of the implementation of its quality framework, ensure that agency-wide standards for the quality of care provided in its federally operated facilities are developed, that facility performance in meeting these standards is systematically monitored over time, and that enhancements are made to its adverse event reporting system. 2. Develop contingency and succession plans for the replacement of key personnel, including area directors. We provided a draft of this report to HHS for its review and comment. HHS provided written comments, which are reproduced in appendix II. HHS concurred with both of our recommendations. In its comments, HHS elaborated on steps that IHS has started taking to improve its oversight of the quality of care provided in its federally operated facilities, which we describe in our report. Specifically, HHS described the development of IHS's quality framework and quality office, plans to develop agency-wide quality measures, the standardization of governing board by-laws, plans to enhance or replace its adverse event reporting system, and its annual mock survey initiative. In its comments, HHS also described IHS's corrective action plan process related to the mock survey initiative, and we added this information to our report. HHS also provided information on steps that IHS is taking to improve the quality of care in its federally operated facilities, including steps taken toward the automation and systemization of provider credentialing. Regarding our second recommendation to develop contingency and succession plans for the replacement of key personnel, including area directors, HHS stated that IHS has already begun to address this recommendation. For instance, HHS reported that on December 2, 2016, IHS distributed succession planning instructions and descriptions of the competencies associated with each position in IHS headquarters, area offices, and facilities to all headquarters office directors and area directors. In addition, HHS reported that IHS has contingency plans in place to ensure continuity of operations in emergency situations. However, as explained in our report, standards for internal control in the federal government state that the agency should have contingency plans in place to respond to sudden personnel changes, which would include non-emergency situations as well. HHS also provided technical comments, which we incorporated where appropriate. We are sending a copy of this report to the Secretary of the Department of Health and Human Services. The report will be available at no charge on GAO's website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or kingk@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. Officials from some area offices in our review reported significant turnover of staff in area office leadership positions. Officials from four of the nine area offices in our review reported that they had at least three area directors in the past 5 years, and three area offices reported that they had at least three chief medical officers. See table 2. In addition, area offices reported 19 federally operated facilities that had 4 or more chief executive officers (CEO) in the past 5 years. One area reported that one of its hospitals had 10 CEOs and 6 clinical directors in the past 5 years. See table 3. In addition to the contact named above, Kristi Peterson, Assistant Director; Kelly DeMots; Krister Friday; Keith Haddock; Lisa Rogers; Patricia Roy; Jennifer Whitworth; and Emily Wilson made key contributions to this report.

Summary:
IHS is charged with providing health care to American Indian/Alaska Native (AI/AN) people who are members or descendants of 567 tribes. AI/AN people born today have a life expectancy that is 4.4 years lower than all races in the United States, and they continue to die at higher rates than other Americans from preventable causes. Concerns about the quality of care provided to AI/ANs in IHS facilities have been identified recently by federal officials and tribal members. GAO was asked to review how IHS oversees the quality of care provided in its facilities. This report examines IHS's oversight of the quality of care provided in its federally operated facilities. GAO reviewed policies and guidance related to quality of care in federally operated facilities and interviewed IHS officials at the headquarters level and all nine area offices with federally operated facilities. GAO also examined documents from governance meetings between area office and facility staff. The Indian Health Service's (IHS) oversight of the quality of care provided in its federally operated facilities has been limited and inconsistent. While some oversight functions are performed at the headquarters level, the agency has delegated primary responsibility for the oversight of care to nine area offices. Area officials stated that the oversight they provide has included, for example, holding periodic meetings with facility staff, reviewing available quality performance data and reviewing adverse events. However, GAO found that this oversight was limited and inconsistent across IHS facilities, due in part to a lack of agency-wide quality of care standards. Specifically, GAO found: variation in the frequency of governing board meetings and the extent to which quality was a standing agenda item at these meetings; limited and inconsistent reporting of quality data across IHS areas and facilities; and inconsistent reporting of adverse events at federally operated facilities. These inconsistencies are also exacerbated by significant turnover in area leadership. Officials from four of the nine area offices in our review reported that they each had at least three area directors in the past five years. According to IHS officials, the agency has not defined contingency or succession plans for the replacement of key personnel, including area directors. IHS's lack of agency-wide quality of care standards and lack of contingency and succession plans for key personnel are inconsistent with federal internal control standards. These standards suggest that agencies should establish and review performance standards and then monitor data to assess the quality of performance over time, and define contingency and succession plans for the replacement of key personnel to help IHS continue achieving its objectives. As a result, IHS officials cannot ensure that facilities are providing quality health care. Recognizing the challenges it faces with overseeing and providing quality health care in its facilities, IHS finalized the development of a quality framework in November 2016 that outlines, at a high level, IHS's plan to develop, implement, and sustain a quality program intended to improve patient experience and ensure the delivery of reliably high quality health care. For example, the framework directs IHS to develop a quality office that will be responsible for identifying resource needs, structures, processes, and supports for an effective and sustainable quality assessment and performance improvement system. More specifically, the framework directs IHS to develop a process for monitoring select performance measures, such as measures of clinical care, patient access, and financial performance, for periodic review by leadership. The framework also explains that IHS will enhance its current patient safety reporting systems to encourage consistent use by staff. If effectively implemented, the quality framework could address the limited and inconsistent oversight of the quality of care provided in federally operated IHS facilities. As of November 2016, IHS officials stated that the agency has not yet selected quality performance measures but has plans to do so. GAO recommends that the Secretary of the Department of Health and Human Services direct the Director of IHS to (1) as it implements its quality framework, ensure that agency-wide standards for the quality of care provided in its federally operated facilities are developed, that facility performance in meeting these standards is monitored over time, and that enhancements are made to its adverse event reporting system, and (2) develop contingency and succession plans for the replacement of key personnel. HHS concurred with GAO's recommendations.