State and Local Restrictions on Employing Unauthorized Aliens

Summary: In May 2011, the Supreme Court ruled in Chamber of Commerce of the United States of America v. Whiting that federal immigration law did not preempt an Arizona statute that authorized or required the suspension or termination of the licenses of businesses that knowingly or intentionally hire unauthorized aliens, and also required that employers within Arizona use the federal government's E-Verify database to check employees' work authorization.

Summary: The doctrine of preemption derives from the Supremacy Clause of the U.S. Constitution, which establishes that federal law, treaties, and the Constitution itself are "the supreme Law of the Land." Thus, one essential aspect of the federal structure of government is that states can be precluded from taking actions that are otherwise within their authority if federal law is thereby thwarted. An act of Congress may preempt state or local action in a given area in any one of three ways: (1) the statute expressly states preemptive intent (express preemption); (2) a court concludes that Congress intended to occupy the regulatory field, thereby implicitly precluding state or local action in that area (field preemption); or (3) state or local action directly conflicts with or otherwise frustrates the purpose of the federal scheme (conflict preemption).

Summary: When it was enacted in 1952, the Immigration and Nationality Act (INA) did not regulate the employment of unauthorized aliens, and several states subsequently enacted measures prohibiting the employment of individuals who were not lawful residents of the United States. In a 1976 decision declining to find one such measure preempted, the Supreme Court recognized that it was "within the mainstream of [a state's] police power" to restrict the employment of aliens within their jurisdiction whose presence in the United States was not authorized by the federal government. However, in 1986, Congress enacted the Immigration Reform and Control Act (IRCA), which amended the INA to sanction employers of unauthorized aliens and expressly preempt states and localities from sanctioning employers other than through "licensing and similar laws." Then, in 1996, Congress enacted the Illegal Immigration Reform and Immigrant Responsibility Act (IIRIRA), which authorized the creation of a pilot program for verifying work authorization that ultimately developed into the program known as E-Verify. Under federal law, use of E-Verify by private entities is generally voluntary, and the Secretary of Homeland Security may not require persons or entities not specified in IIRIRA to participate.

Summary: Prior to Whiting, the federal courts of appeals had disagreed as to whether IRCA and IIRIRA preempted state and local measures like the Arizona statute. Some found that state licensing measures were within IRCA's "savings clause" even when the state independently determined whether an employer employed unauthorized aliens, and that IIRIRA did not prohibit states from requiring E-Verify use. Others found that licensing provisions disrupted the balance struck by Congress between deterring illegal immigration, minimizing burdens on employers, and preventing discrimination, and Congress did not want use of E-Verify to be mandatory.

Summary: The majority in Whiting relied primarily upon the "plain meaning" of IRCA and IIRIRA, while two dissents relied more heavily upon the legislative history and overall purpose of IRCA. The majority's decision apparently opens the door to additional state and local restrictions upon employing unauthorized aliens. However, several lower court decisions subsequent to Whiting suggest that any state and local E-Verify measures, in particular, may need to parallel federal law to avoid being found to be preempted. Measures that would criminalize the seeking or performance of work by unauthorized aliens were not at issue in Whiting, but were later found to be preempted in the Supreme Court's June 25, 2012, decision in Arizona v. United States.

This report discusses state and local restrictions upon employing unauthorized aliens in light of the May 26, 2011, decision by the Supreme Court in Chamber of Commerce of the United States of America v. Whiting . The Court's decision in Whiting arose from a facial challenge to the Legal Arizona Workers Act (LAWA), a predecessor of S.B. 1070, which authorized or required the suspension or termination of the licenses of businesses that knowingly or intentionally hire unauthorized aliens, as well as required that employers in Arizona use the federal government's E-Verify database to check employees' work authorization. Business, labor, and civil rights organizations had asserted that LAWA's licensing provisions were expressly and impliedly preempted by federal law and that its E-Verify provision was impliedly preempted.

The doctrine of preemption derives from the Supremacy Clause of the Constitution, which establishes that federal law, treaties, and the Constitution itself are "the supreme Law of the Land." Thus, one essential aspect of the federal structure of government is that states can be precluded from taking actions that are otherwise within their authority if federal law is thereby thwarted. An act of Congress may preempt state or local action in a given area in any one of three ways: (1) the statute expressly states preemptive intent (express preemption); (2) a court concludes that Congress intended to occupy the regulatory field, thereby implicitly precluding state or local action in that area (field preemption); or (3) state or local action directly conflicts with or otherwise frustrates the purpose of the federal scheme (conflict preemption).

In finding that LAWA was not preempted by federal immigration law, a majority of the Court apparently opens the door to additional state and local restrictions upon employing unauthorized aliens. However, several lower court decisions subsequent to Whiting suggest that any state and local E-Verify measures, in particular, may need to parallel federal law to avoid being found to be preempted. Measures that would criminalize the seeking or performance of work by unauthorized aliens were not at issue in Whiting , but were found to be preempted in the Supreme Court's June 25, 2012, decision in Arizona v. United States .

This report does not address state and local authority to enforce federal immigration law, or state and local measures designed to deter unauthorized aliens from entering into or settling within a jurisdiction by restricting their ability to obtain housing, perform work, or receive state or local public benefits. These topics are addressed in other CRS Reports, including CRS Report R42719, Arizona v. United States: A Limited Role for States in Immigration Enforcement , by [author name scrubbed] and [author name scrubbed], and CRS Report R41423, Authority of State and Local Police to Enforce Federal Immigration Law , by [author name scrubbed] and [author name scrubbed]. The report also does not address potential due process or other issues that could be raised by state and local measures restricting the employment of unauthorized aliens.

The Immigration and Nationality Act (INA) of 1952 established a "comprehensive federal statutory scheme for regulation of immigration and naturalization" and set "the terms and conditions of admission to the country and the subsequent treatment of aliens lawfully in the country." However, the INA did not originally regulate employment of unauthorized aliens. A number of states subsequently enacted measures prohibiting the employment of individuals who were not lawful residents of the United States. The constitutionality of one such measure—a California law providing that "[n]o employer shall knowingly employ an alien who is not entitled to lawful residence in the United States if such employment would have an adverse effect on lawful resident workers"—was at issue in the Supreme Court's 1976 decision in De Canas v. Bica . There, in declining to hold that the California statute was preempted by federal immigration law, the Court noted that

Power to regulate immigration is unquestionably exclusively a federal power. But the Court has never held that every state enactment which in any way deals with aliens is a regulation of immigration and thus per se pre-empted by this constitutional power, whether latent or exercised.

Further, the Court characterized prohibiting the employment of persons not entitled to work in the United States as "within the mainstream of [the State's] police power," and observed that the federal government had "at best" expressed a "peripheral concern" with the employment of unlawfully present aliens.

Federal regulation of the employment of unauthorized aliens expanded significantly in 1986, when the Immigration Reform and Control Act (IRCA) was enacted. IRCA amended the INA to make it unlawful for a person or other entity to hire, or to recruit or refer for a fee for employment in the United States, an alien, knowing that the alien is unauthorized. IRCA also required employees to attest their eligibility to work and present specified identification documents, which employers are to examine and attest that they appear to be genuine. The employer and employee attestations are accomplished through "I-9 forms," which are key to the verification process under IRCA. Employers who attempt to comply in good faith with these requirements are generally deemed to have complied notwithstanding technical or procedural failures to comply. Employers who violate IRCA's prohibitions on the unlawful employment of aliens may be subject to civil and/or criminal penalties under federal law. However, IRCA provides that, "[t]he provisions of this section preempt any State or local law imposing civil or criminal sanctions ( other than through licensing and similar laws ) upon those who employ, or recruit or refer for a fee for employment, unauthorized aliens." The language within the parentheses is commonly referred to as the "savings clause" because it potentially saves state and local "licensing and similar laws" from preemption. However, even when a state and local measure is not expressly preempted, as is the case here, the possibility of implied preemption remains.

Ten years later, Congress expanded upon IRCA's employment verification regime when it enacted the Illegal Immigration Reform and Immigrant Responsibility Act (IIRIRA). IIRIRA directed the Attorney General (later the Secretary of Homeland Security) to conduct three pilot programs for electronic employment eligibility confirmation, one of which, the Basic Pilot Program, ultimately developed into the E-Verify program. IIRIRA also provided that participation by private parties in the pilot programs is generally voluntary, and the Secretary of Homeland Security "may not require any person or other entity to participate." However, as an incentive for participation, IIRIRA provides that entities which opt to participate and obtain confirmation of the identify and employment eligibility of employees establish a rebuttable presumption that they have not violated IRCA.

Despite the enactment of IRCA and IIRIRA, concerns about the employment of unauthorized aliens persisted, particularly in states and localities that are significantly affected by unauthorized immigration. Beginning in 2006, several of these states and localities enacted or considered measures that would deter unauthorized aliens from entering or settling in their jurisdiction by restricting access to work, housing, and benefits. Those measures seeking to limit unauthorized aliens' ability to obtain work typically sanctioned employers of unauthorized aliens and/or required employers to use E-Verify to verify employees' work authorization.

As discussed below, the federal courts of appeals reached differing conclusions as to whether these measures were preempted by federal immigration law before the Supreme Court issued its decision in Whiting . Some courts found that state licensing measures were within IRCA's "savings clause" even when the state independently determined whether an employer employed unauthorized aliens, and that IIRIRA did not prohibit a state from requiring use of E-Verify. Others found that such measures were preempted because the licensing provisions disrupted the balance struck by Congress between deterring illegal immigration, minimizing burdens on employers, and preventing discrimination against those perceived as "foreign," and Congress did not want use of E-Verify to be mandatory. The Supreme Court granted certiorari in Whiting , in part, because of these differences among the courts of appeals.

Prior to the Supreme Court's decision in Whiting , some reviewing federal and state courts found that state and local measures suspending or revoking the licenses of businesses found to have employed unauthorized aliens and/or requiring employers within the jurisdiction to use E-Verify were not preempted by federal immigration law. For example, in Chicanos por la Causa v. Napolitano , the U.S. Court of Appeals for the Ninth Circuit unanimously rejected the plaintiffs' argument that the Legal Arizona Workers Act was expressly preempted because it provided for the suspension and termination of licenses of employers whom state officers determined had hired unauthorized aliens. The plaintiffs had asserted both that LAWA's savings clause "encompass[es] only licenses to engage in specific professions, such as medicine or law," and that Congress intended to permit revocation of the licenses of only those entities whom the federal government had determined violated IRCA. However, in an opinion that gave rise to the Supreme Court's decision in Whiting , the Ninth Circuit rejected these arguments based on the "plain" or dictionary meaning of "license," as well as the legislative history of IRCA. The Ninth Circuit also declined to find that LAWA's licensing provisions were impliedly preempted because of a "speculative, hypothetical possibility" of conflict in the practical operation of state and federal laws. The Ninth Circuit similarly found that LAWA's E-Verify requirements are not impliedly preempted by IIRIRA since Congress's making E-Verify voluntary at the federal level "did not in and of itself" indicate that Congress intended to prohibit states from requiring participation. A majority of the U.S. Court of Appeals for the Tenth Circuit also concluded that the E-Verify requirement of the Oklahoma Taxpayer and Citizen Protection Act of 2007 was not impliedly preempted in its decision in Chamber of Commerce of the United States of America v. Edmondson .

Other courts reached contrary conclusions, finding that state and local licensing measures and/or E-Verify requirements are preempted by federal immigration law. In particular, in Lozano v. City of Hazleton , the U.S. Court of Appeals for the Third Circuit unanimously found that a city ordinance with licensing provisions and an E-Verify requirement like those in LAWA was impliedly preempted. Although it reversed the district court's finding that the ordinance's licensing provisions were expressly preempted because they constituted "sanctions" under IRCA, the Third Circuit nonetheless found that the provisions impermissibly conflicted with IRCA because they disrupted the balance that Congress had crafted between the "competing policy objectives of effectively deterring employment of unauthorized aliens, minimizing the resulting burden on employers, and protecting unauthorized aliens and citizens perceived as 'foreign' from discrimination." According to the Third Circuit, the ordinance "substantially undermine[d]" this balance by prioritizing deterring the employment of unauthorized aliens over Congress's other objectives. The Third Circuit further found that the ordinance "contravene[d] congressional objectives by requiring the use of E-Verify when Congress had declined to do so." In so doing, the Third Circuit noted that other courts, including the Ninth Circuit, had found otherwise, but suggested that these decisions "fail[ed] to afford proper weight to the purposes underlying Congress's decision to retain E-Verify as a voluntary program."

In Whiting , the Supreme Court upheld LAWA's licensing provisions and E-Verify requirements in a 5-3 decision authored by Chief Justice Roberts. Justice Thomas concurred in the outcome and in those parts of the opinion which found that the statute's licensing provisions are not expressly preempted given the plain meaning of the relevant passages of IRCA and LAWA, and that the statute's E-Verify requirement is not impliedly preempted because it does not conflict with federal law. Three Justices dissented in two separate opinions which would have found LAWA's licensing provisions expressly preempted and its E-Verify requirements impliedly preempted. Justice Kagan recused herself.

The controlling opinion, written by Chief Justice Roberts, focused first upon the "plain wording" of IRCA's savings clause and the Arizona statute, noting that federal law saves from express preemption "licensing and similar laws" and that the Arizona law, "on its face, purports to impose sanctions through licensing laws." The petitioners had argued that LAWA does not constitute a licensing law under IRCA because LAWA defines "license" broadly, to include "any agency permit, certificate, approval, registration, charter or similar form of authorization," and governs only the suspension or termination of licenses, not their issuance. However, the Court rejected both arguments. It found that LAWA was a licensing law, in part, because LAWA's definition of "license" largely "parroted" the definition of "license" given in the Administrative Procedure Act (APA). The Court also found that laws which do not purport to govern the issuance of licenses constitute "licensing laws" under IRCA because a contrary construction would "run[] contrary to the definition [of license] that Congress itself has codified" in the APA, and "is also contrary to common sense." Further, the Court suggested that even if LAWA were not a "licensing law" for purposes of IRCA, IRCA's savings clause also encompasses "similar laws." While the petitioners had also asserted that the legislative history of IRCA supported a narrow interpretation of the savings clause, the Court found these arguments unpersuasive given that

no such limit is remotely discernible in the statutory text. Absent any textual basis, we are not inclined to limit so markedly the otherwise broad phrasing of the savings clause.... Congress's authoritative statement is the statutory text, not the legislative history.

The controlling opinion also found that LAWA's licensing provisions are not impliedly preempted by IRCA. In so finding, the Court noted that IRCA "specifically preserved authority for states" to impose sanctions through licensing and similar laws upon persons who employ unauthorized aliens. According to the Court, because Congress specifically preserved this authority, "it stands to reason" that Congress did not intend that the federal system would be exclusive and necessarily conflict with any state system. The Court further noted that Arizona's system, in particular, did not conflict with federal law, but rather "closely tracks IRCA's provisions in all material respects," adopting IRCA's definition of "unauthorized alien" and prohibiting state investigators from independently determining aliens' work authorization. The Court also cited 8 U.S.C. §1373(c), which requires federal officials to respond to state and local inquiries regarding persons' immigration status, as evidence that Congress did not intend for the federal system to be exclusive. In addition, the Court rejected petitioners' argument that LAWA upsets the balance that Congress sought to strike when enacting IRCA. It did so, in part, because "[r]egulating in-state businesses through licensing laws has never been ... an area of dominant federal concern," and LAWA does not "directly interefere[] with the operation of [any federal] program." It also rejected petitioners' assertion that LAWA's penalties for licensing violations, which the petitioners and Justice Breyer characterized as a "business death penalty," are such significant sanctions that they disrupt the balance struck by Congress. Instead, the Court viewed these sanctions as "typical attributes of a licensing regime," and noted that IRCA sought to balance state and federal interests, not just deterring unauthorized immigration, minimizing burdens on employers, and preventing discrimination against those perceived as "foreign." According to the Court, in enacting IRCA,

The principle that Congress adopted was not that the Federal Government can impose large sanctions, and the States only small ones.... [I]n preserving to the States the authority to impose sanctions through licensing laws, Congress did not intend to preserve only those state laws that would have no effect.

The Court further found that LAWA's E-Verify requirements were not impliedly preempted by federal law. The petitioners had asserted that these requirements conflicted with federal law because mandatory use of E-Verify impedes Congress's purpose in establishing a reliable and non-burdensome system of work authorization. However, the Court found that Arizona's requiring the use of E-Verify does not conflict with federal law because the text of IIRIRA only prohibits the Secretary of Homeland Security from requiring the use of E-Verify, not anyone else. The Court also emphasized that LAWA's E-Verify requirement is "entirely consistent" with federal law given that the consequences of using E-Verify were the same under federal and state law (i.e., the person was not entitled to a presumption that they had not violated IRCA). The Court further found that "the Federal Government has consistently expanded and encouraged the use of E-Verify." In addition, the Court noted that even the federal government disagreed with the petitioners' assertion that the E-Verify system would be overwhelmed—and Congress's purposes defeated—if other jurisdictions also required use of E-Verify.

Three Justices dissented in two separate opinions. Justice Breyer, in an opinion which Justice Ginsburg joined, rejected the majority's characterization of LAWA as a "licensing law" falling within IRCA's savings clause. According to this dissent, LAWA should be found to be expressly preempted because the legislative history of IRCA, coupled with the balance that IRCA established between deterring unauthorized immigration, minimizing burdens on employers, and preventing discrimination against those perceived as "foreign," demonstrate that Congress intended to exempt from preemption only a narrow class of state laws, such as those governing the licensing of agricultural labor contractors. Justice Breyer specifically objected to the majority's resort to the plain meaning of "license" in determining Congress's intent, asserting that the "statutory context" of the phrase, not its dictionary meaning, should be used to ascertain its meaning. He also criticized the majority opinion on the grounds that the opinion would create obstacles to the accomplishment and execution of the full purposes and objectives of Congress by "permit[ing] States to turn virtually every permission-related state law into an employment-related 'licensing' law." The dissent similarly would have found LAWA's E-Verify requirements preempted because, "[b]y making mandatory that which federal law seeks to make voluntary, the state provision stands as a significant 'obstacle to the accomplishment and execution of the full purposes and objectives of Congress.'" In particular, Justice Breyer suggested that the majority was mistaken in inferring permission for states to make the program mandatory from language in IIRIRA prohibiting the Secretary of Homeland Security from requiring the use of E-Verify.

Justice Sotomayor would also have found LAWA's licensing provisions expressly preempted. However, unlike Justice Breyer, she would have done so on the grounds that IRCA expressly preempts laws that permit states and localities to determine whether an employer has violated IRCA. Her dissent reached this conclusion primarily because the legislative history of IRCA evidenced Congress's desire to replace the pre-IRCA "patchwork" of state laws prohibiting the employment of unauthorized aliens with a "uniformly" enforced federal law. Accordingly, the dissent would find that states and localities are preempted from independently adjudicating whether an employer has employed an unauthorized alien. In support of this conclusion, the dissent also noted the limitations on use of I-9 forms under federal law, as well as the fact that federal law provides no mechanism for states to access information regarding aliens' work authorization. The dissent similarly would have found LAWA's E-Verify requirement impliedly preempted because it is "in contravention of the significant policy objectives motivating Congress' decision to make participation in the E-Verify program voluntary." While noting that the fact that state law makes mandatory something Congress made voluntary does not, per se , result in preemption, Justice Sotomayor emphasized that LAWA differs from other state laws in that it directly regulates the relationship between the federal government and private parties by requiring private employers to use the federal E-Verify database. The dissent also noted the U.S. government's "uniquely federal interest" in managing the use of the E-Verify database, and that Congress's decision not to create a mandatory program was based, in part, on the costs of such a program.

The Supreme Court's decision in Whiting apparently opens the door to the enactment of additional state and local measures restricting the employment of unauthorized aliens. However, several lower court decisions subsequent to Whiting suggest that any state and local E-Verify measures, in particular, may need to parallel federal law to avoid being found to be preempted. For example, a state court in Louisiana struck down a state statute that required employers to use E-Verify to verify the work authorization of all employees after finding that it was preempted by federal rules and regulations, which generally provide that E-Verify may only be used to verify the employment eligibility of new hires, not current employees. In another case, a federal district court in Missouri found that a municipal ordinance which would have fined employers who did not use E-Verify was preempted because it imposed sanctions that were not contemplated by federal law. Under federal law, use of E-Verify is generally voluntary, although those who do use E-Verify are generally entitled to a presumption that they have not employed an unauthorized alien. There do not appear to be any similar, post- Whiting decisions finding state or local licensing measures to be preempted because they differ significantly from the provisions of federal law. However, the controlling opinion in Whiting repeatedly emphasized how closely LAWA "tracks IRCA's provisions in all material respects," and reviewing courts could potentially find that state and local measures that "track" IRCA less closely are preempted, as they have with state E-Verify measures.

There have been calls for Congress to preempt state and local E-Verify requirements, in particular, because of the burdens that complying with various state and local requirements could impose on employers. Legislation has been introduced in recent Congresses that would do this. Legislation has also been introduced in recent Congresses that would expressly preempt state and local measures that prohibit employers from verifying new hires or current employees through E-Verify, as well as amend the employer sanctions provisions of the INA to establish that neither they nor any other federal law preempt state or local measures imposing civil or criminal sanctions upon those who employ unauthorized aliens. Along with the Supreme Court's decision in Whiting , the enactment of such legislation could also potentially shape the extent and nature of state and local restrictions on employing unauthorized aliens.

Question: What was the initial impact of INA?

Answer: When it was enacted in 1952, the Immigration and Nationality Act (INA) did not regulate the employment of unauthorized aliens, and several states subsequently enacted measures prohibiting the employment of individuals who were not lawful residents of the United States.

Question: How did courts rule on these state measures?

Answer: In a 1976 decision declining to find one such measure preempted, the Supreme Court recognized that it was "within the mainstream of [a state's] police power" to restrict the employment of aliens within their jurisdiction whose presence in the United States was not authorized by the federal government.

Question: What was the effect of the IRCA?

Answer: However, in 1986, Congress enacted the Immigration Reform and Control Act (IRCA), which amended the INA to sanction employers of unauthorized aliens and expressly preempt states and localities from sanctioning employers other than through "licensing and similar laws."

Question: What did the IIRIRA create?

Answer: Then, in 1996, Congress enacted the Illegal Immigration Reform and Immigrant Responsibility Act (IIRIRA), which authorized the creation of a pilot program for verifying work authorization that ultimately developed into the program known as E-Verify.

Question: To what extent is E-Verify required?

Answer: Under federal law, use of E-Verify by private entities is generally voluntary, and the Secretary of Homeland Security may not require persons or entities not specified in IIRIRA to participate.

Question: How were different arguments in Whiting divided?

Answer: The majority in Whiting relied primarily upon the "plain meaning" of IRCA and IIRIRA, while two dissents relied more heavily upon the legislative history and overall purpose of IRCA.

Question: What does the majority's decision support?

Answer: The majority's decision apparently opens the door to additional state and local restrictions upon employing unauthorized aliens.

Question: How is this affected by other rulings?

Answer: However, several lower court decisions subsequent to Whiting suggest that any state and local E-Verify measures, in particular, may need to parallel federal law to avoid being found to be preempted. Measures that would criminalize the seeking or performance of work by unauthorized aliens were not at issue in Whiting, but were later found to be preempted in the Supreme Court's June 25, 2012, decision in Arizona v. United States.


DOD Health Care: Defense Health Agency Should Improve Tracking of Serious Adverse Medical Events and Monitoring of Required Follow-up

Adverse medical events are unintended incidents that may harm a patient. Serious adverse medical events, called sentinel events, have specific follow-up requirements. The National Defense Authorization Act for Fiscal Year 2017 (NDAA 2017) requires DHA to assume the military services' administrative responsibilities, such as adverse medical event reporting, for all MTFs beginning October 1, 2018.

The NDAA 2017 included a provision for GAO to examine the reporting and resolving of adverse medical events in the military health system. Among other objectives, this report reviews (1) the extent to which sentinel events and RCA reports are tracked and DHA ensures it has received complete information, and (2) the extent to which DHA ensures it has received MOS reports. GAO examined relevant policies; analyzed the most current available data on sentinel events from 2013 through 2016; and interviewed officials with DHA, the military services, and four MTFs selected for variety in military service, size, and geographic location.

GAO found that the process for tracking the most serious adverse medical events, called sentinel events, and their root cause analysis (RCA) reports are fragmented, impeding the Defense Health Agency's (DHA) ability to ensure that it has received complete information. Unlike other adverse medical events, sentinel events—which may result in severe harm or death—have additional reporting requirements that must be met within specified time frames. For example, military treatment facility (MTF) officials must develop RCA reports, which identify causal factors and corrective actions for sentinel events. However, because the database that DHA uses to collect information on adverse medical events does not currently have the capability to track this information, the military services (Army, Navy, and Air Force) and DHA each maintain their own tracking records for sentinel events and RCA reports. Due to these fragmented tracking efforts, DHA reconciles its information on sentinel events and RCA reports through monthly emails to the military services—a time-consuming, inefficient process. DHA officials emphasized that this process relies on the military services' cooperation because DHA does not currently have the authority to compel their responses. Moreover, despite DHA's reconciliation efforts, GAO identified discrepancies and missing information in DHA's tracking record. As a result, DHA lacks critical information about why a sentinel event may have occurred and what actions, if any, MTFs should take to prevent similar incidents in the future. Recently, DHA replaced its previous system of emails with a new tracker tool that can be accessed on the military health system website. However, the new tracker does not allow the military services to make edits, and as a result, any corrections or additional information must be submitted to DHA via email, which may perpetuate previous inefficiencies.

GAO found that DHA cannot ensure that it is receiving all reports on the implementation of corrective actions identified in RCA reports as required by a March 2015 memo. DHA officials stated that MTFs could meet this requirement by submitting copies of their measures of success (MOS) reports, which may be required by the Joint Commission, a hospital accrediting organization. As of September 2017, DHA had received 27 MOS reports for the 319 sentinel events that were reported in 2016. However, DHA does not know how many reports it is missing because MOS reports are not required for every sentinel event, and DHA did not began reconciling its information for these reports until January 2018, when it implemented its new tracker tool. Furthermore, GAO found that the new tracker tool documents the aggregate number of MOS reports received and does not indicate whether individual sentinel events have an MOS report, impeding DHA's ability to identify which reports are missing. This issue is compounded by the fact that the military services either track MOS reports in different ways or not at all, and military service officials said that DHA's requirement for MOS report submission is not clear. DHA officials stated that they expect to clarify this requirement in their update to the patient safety policy. Because it is unable to ensure it has received all reports on the implementation of corrective actions, DHA could be missing important information that could be used to help inform broader, system-wide patient safety improvement efforts.

GAO recommends that the Assistant Secretary of Defense (Health Affairs) ensure DHA (1) improve tracking of sentinel events and RCA reports, and (2) clarify its requirements for submitting reports on the implementation of corrective actions and consistently track and reconcile individual reports. DOD agreed with these recommendations.

One of the key patient safety responsibilities within the Department of  Defense’s (DOD) Military Health System (MHS) is the reporting and  tracking of adverse medical events—unintended health care incidents,  such as administering incorrect medication or treatment to a patient, that  may or may not result in harm. DOD’s Assistant Secretary of Defense for  Health Affairs sets policies—including patient safety policies—for the  MHS, and the Defense Health Agency (DHA) oversees the  implementation of these policies. The military services (Army, Navy, and  Air Force) and the National Capital Region (NCR) currently manage their  own hospitals and clinics, referred to as military treatment facilities (MTF).  In doing so, they develop policies that must align with DOD’s policies,  including policies for reporting adverse medical events that occur in their  facilities. However, the National Defense Authorization Act for Fiscal  Year 2017 (NDAA 2017) requires the transfer of administrative control of  MTFs, including the reporting of adverse medical events, to DHA,  beginning October 1, 2018.

Information gleaned from the reporting and tracking of adverse medical  events provides the military services, NCR, and DHA with critical  information that can be used to make improvements in the way health  care is delivered across the MHS. MTF officials are required to report all  adverse medical events in DHA’s Joint Patient Safety Reporting (JPSR)  system, which captures information on the factors—such as medication or  equipment—that may have contributed to the event. The most serious  type of adverse medical event is called a sentinel event, which can result  in unexpected death or serious physical or psychological harm to the  patient. For every sentinel event, MTF officials are required to prepare a  root cause analysis (RCA) report, which is intended to identify the factors  that caused or contributed to the sentinel event, as well as corrective  actions needed to prevent future incidents. For most sentinel events, an  additional report—a Measures of Success (MOS) report— may be  required by the Joint Commission, a hospital accrediting organization that  reviews sentinel events and assigns follow-up activities to accredited  MTFs for these events. This MOS report includes the determination of  whether the implementation of identified corrective actions was  successful.

In 2014, news articles highlighted concerns about medical errors and  lapses in patient safety at MTFs, including staff’s reluctance to report  these errors. In August 2014, DOD released a review of the MHS that  addressed patient safety, among other issues. While DOD’s review  found that the culture of safety within the system was comparable to that  found in the civilian sector, the report made a number of  recommendations that included the clarification of policy on the definitions  for sentinel events to reduce variation in interpretation. In December  2017, the DOD Inspector General released a follow-up report focused on  patient safety, which found that DOD had established courses of action to  resolve all relevant patient safety findings identified in the 2014 review.

The NDAA 2017 included a provision for us to examine several issues  related to DOD’s delivery of health care, such as reporting and resolving  adverse medical events. In this report, we examine  1.  the extent to which the military services’ and NCR’s policies align with  DOD’s policies for reporting adverse medical events;  2.  the extent to which the military services, NCR, and DHA track sentinel  events and RCA reports, and the extent to which DHA ensures it has  received complete information;  3.  the extent to which DHA ensures it has received MOS reports; and  4.  how DHA uses information about adverse medical events to make  improvements in its health care system.

To examine the extent to which the military services and NCR have  policies that align with DHA’s policies for reporting adverse medical  events, we reviewed and compared the military services’ and NCR’s  policies with DHA’s policies. We also reviewed relevant documents  related to these policies, including updated memorandums. In addition,  we interviewed officials from the military services’ medical commands and  NCR’s medical directorate to determine how they manage patient safety  efforts pertaining to reporting adverse medical events throughout their  MTFs and how the future transfer of this authority to DHA may affect  these efforts. We also conducted site visits to a non-generalizable  sample of four MTFs—Dwight. D. Eisenhower Army Medical Center (Fort  Gordon, Ga.), Robert E. Bush Naval Hospital (Twentynine Palms, Calif.),  Mike O’Callaghan Federal Medical Center (Nellis AFB, Nev.), and Walter  Reed National Military Medical Center (Bethesda, Md.)—to better  understand how the military services and NCR report adverse medical  events in their facilities. Our site selection criteria included one MTF from  each of the military services and NCR with a range of hospital sizes,  geographic diversity, and numbers of reported adverse medical events.  We also interviewed DHA officials, including officials from DHA’s Patient  Safety Program and the Patient Safety Analysis Center, and reviewed  relevant documentation about their patient safety policies, their plans to  update these policies, and how the future transfer of MTF administrative  responsibilities to DHA will impact the reporting of adverse medical  events.

To determine the extent to which the military services, NCR, and DHA  track sentinel events and RCA reports, we reviewed relevant military  service, NCR, and DHA policies to identify requirements for sentinel  events and RCA reports. We interviewed officials from the military  services, NCR, and DHA about their tracking processes for sentinel  events and RCA reports. We also interviewed officials during our site  visits to the four MTFs about how they transmit information about sentinel  events and their required RCA reports to their respective military service  or NCR. We evaluated our findings against the GAO Fragmentation,  Overlap, and Duplication: An Evaluation and Management Guide to  identify any potential fragmentation.

To determine how DHA ensures it has complete information, we reviewed  relevant DHA policies, interviewed DHA officials, and obtained documents  outlining DHA’s monitoring process. We obtained the most current data  available on reported sentinel events and RCA reports from 2013 through  2016 from tracking records maintained by each of the military services,  NCR, and DHA, and we compared the data to assess DHA’s monitoring  efforts. We interviewed military service, NCR, and DHA officials about  how these data are collected and documented, as well as the steps taken  to ensure that the data are complete, and on this basis we determined  that these data were sufficiently reliable for the purposes of our audit  objective.

To determine the extent to which DHA ensures that it has received MOS  reports, we reviewed relevant military service, NCR, and DHA policies to  identify requirements for completing and tracking these reports. We also  reviewed documentation on requirements for MOS reports from the Joint  Commission. We interviewed officials from the four MTFs we visited  about how they transmit MOS reports to their respective military services  or NCR. To determine how DHA monitors this information, we obtained  data from DHA’s tracking record on total MOS reports for reported  sentinel events from 2016, the first full year that such reports were  required to be submitted to DHA. We interviewed military service, NCR,  and DHA officials about how these data are collected and documented as  well as steps to ensure that these data are complete, and we determined  that these data were sufficiently reliable for the purposes of our audit  objective. We also assessed efforts to monitor MOS reports against  federal standards for internal controls.

To determine how DHA uses information about adverse medical events to  make improvements in its health care system, we reviewed  documentation on DHA’s patient safety initiatives, relevant DHA  publications, such as the Patient Safety Annual report, and the MHS  website. We also interviewed military service, NCR, and MTF officials  about the patient safety initiatives implemented by DHA, including how  these initiatives are communicated to them and how the information is  used to make improvements in their facilities.

We conducted this performance audit from February 2017 to April 2018 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

DHA requires the military services and NCR to categorize adverse  medical events by severity, using seven categories defined by the Agency  for Healthcare Research and Quality (AHRQ), ranging from unsafe  condition to death. (See table 1.)

MTF personnel must enter all adverse medical events in DHA’s JPSR  system, which was implemented in June 2011 in response to a statutory  mandate for the MHS to establish a patient care error reporting and  management system. The JPSR system is intended to provide ways to  facilitate the self-reporting, collection, and aggregation of adverse medical  event data across the MHS. The system includes prompts for information  about factors that may have contributed to the event, such as medication  or equipment, as well as the assignment of a severity category.

From 2013 through 2016, the total number of reported adverse medical  events in the JPSR system increased from over 76,000 to about 108,000.  When analyzing adverse medical events, DHA groups the data into three  categories—near miss, no harm, and harm. The highest increase was in  the near miss category (about 36,000 to 56,000) while the other two  categories increased to a lesser extent. According to an internal DHA  publication, a higher increase in near miss events alongside a decrease  in harm and no harm events is considered a positive trend because it  shows that more potential adverse medical events are being detected  before they reach the patient. (See fig. 1.)

The most severe types of adverse events are called sentinel events. In  March 2015, DOD issued a memo that revised its previous definition of a  sentinel event, which was an unexpected occurrence involving death or  serious physical or psychological injury or risk. The revised definition  states that a sentinel event is a patient safety event (not primarily related  to the natural course of the patient’s illness or underlying condition) that  results in death, permanent harm, or severe temporary harm. The  revised definition also added a list of events outlined by the Joint  Commission and the National Quality Forum that go beyond those that  result in unexpected death or serious physical or psychological harm to  the patient. (See app. I for the revised definition of sentinel events.)

From 2013 through 2016, DHA’s data showed an increase in the total  number of reported sentinel events—both medical and dental—from 121  to 319. Medical sentinel events approximately doubled from 101 to 206,  while dental sentinel events increased more than fivefold from 20 to 113.  (See fig. 2.) The sharp increase in events in 2015 may have been  influenced by DHA’s revised definition of sentinel events as well as the  Army’s inclusion of dental events that meet sentinel event criteria. A  DHA internal publication also noted that a culture shift in patient safety  reporting could have contributed to this increase.

As with all adverse medical events, MTF personnel must enter sentinel  events into the JPSR system; however, sentinel events have additional  reporting requirements that must be met within specified time frames. For  example, DHA policy requires MTF officials to report sentinel events to  their respective military service or NCR within 24 hours after they become  aware of the event. (See fig. 3, step 1.) MTFs also must report to and  comply with sentinel event reporting requirements established by the  Joint Commission. These requirements include the development and  submission of an RCA report for each sentinel event to identify the causal  and contributory factors associated with the event as well as the  corrective actions needed to prevent future incidents. The military  services and NCR submit copies of their RCA reports to DHA, which rates  the corrective actions included in each RCA report as stronger,  intermediate, or weaker based on an estimation of their effectiveness.  (See fig. 3, step 2.) DHA uses commercial process improvement software  called TapRooT to assist with the development of RCA reports, and DHA  requires all MTFs to use a methodology for its RCA reports that is  currently supported by this software.

Additionally, once the Joint Commission approves an RCA report and its  associated corrective action plan, it may require the preparation of an  MOS report that assesses the corrective actions 4 months after an RCA  report is submitted to determine whether the implementation of corrective  actions and outcome measures was successful. Unlike RCA reports,  these reports are only required for selected sentinel events as determined  by the Joint Commission. DOD’s March 2015 memo that revised the  definition of sentinel events contained an additional requirement for the  military services and NCR to submit copies of reports on the  implementation of corrective actions to DHA. (See fig. 3, step 3.) DHA  officials told us that MTFs could submit their MOS reports to meet this  requirement. For this report we use the term MOS report when referring  to this requirement.

Transition of MTF Administrative Responsibilities to DHA

Responsibility for the delivery of care in the MHS is shared among the  Office of the Assistant Secretary of Defense (Health Affairs), DHA, the  military service medical commands, and NCR’s medical directorate.  MTFs are currently under the direction and control of the Army Medical  Command, the Navy Bureau of Medicine and Surgery, and the Air Force  Major Commands. MTFs within the NCR are under the direction and  control of the NCR medical directorate, which reports to DHA. (See fig. 4.)

The NDAA 2017 included a provision that requires the Director of DHA to  be responsible for the administration of every MTF beginning October 1,  2018. This responsibility includes budgetary matters, patient safety  activities, information technology, and health care administration and  management, among other things. As part of the patient safety activities,  DHA officials will assume responsibility for adverse medical event  reporting. As required, DHA submitted initial plans to Congress in both  March and June 2017 about how it plans to implement its new  responsibilities. In September 2017, we reported that DHA’s plans  summarize its new roles and responsibilities at a high level and that a  significant amount of work remained to complete the implementation  plan. On March 30, 2018, DOD submitted an additional implementation  plan and stated that its final implementation plan will be completed by  June 30, 2018.

The Military Services’ and NCR’s Adverse Medical Event Policies Do Not Consistently Align with DOD’s Policies, but Transition to DHA’s Policies Is Planned

Policies established by the military services and NCR for reporting  adverse medical events are developed to implement DOD’s policies— which tend to be broad—and may include additional requirements specific  to their branch of military service. However, we found that aspects of  these policies do not consistently align with DOD’s policies, including the  definitions for adverse medical events and sentinel events, as well as  requirements for entering events into the JPSR system. (See table 2.)

Definition of adverse medical event. The Navy uses DOD’s  definition of an adverse medical event—which includes events that  may or may not result in harm to the patient. However, the Army, Air  Force, and NCR defined this term more narrowly, to include only an  event that causes actual harm to the patient. While the difference in  these definitions could potentially result in the underreporting of  events, officials from all four of the MTFs we visited told us that the  discrepancy does not have much of an impact because the individuals  who report these events—MTF personnel—are unlikely to be aware of  the difference and likely follow the broader DOD definition.

Policy on entering events in the JPSR system. Only NCR’s policy  states that adverse medical events should be entered into the JPSR  system. However, Army, Navy, and Air Force officials as well as  officials from one MTF we spoke with stated that they record all  adverse medical events in the JPSR system even though their  policies do not require it.

Policy on reviewing adverse medical events. NCR and Air Force  policies, which align with DOD’s policy, require a review of an adverse  event that is based on whether there is harm to the patient. In  contrast, Army and Navy policies do not require that an adverse  medical event be reviewed on the basis of whether there is harm to  the patient, but they do require the event to be reviewed for the level  of severity and probability of recurrence. However, Navy officials  told us that reviewing an event for severity includes an assessment of  harm to the patient even though this is not clearly stated in their  policy. Additionally, all of the MTF officials we interviewed said that  the JPSR system requires them to review an adverse medical event  on the basis of whether there is harm to the patient and to assign a  harm scale category.

Memorandum that revised the definition of a sentinel event. Only  the Army’s draft policy aligned with DOD’s March 2015 revised  definition of sentinel events. However, MTF officials from the other  military services and NCR told us that even though the revised  definition was not in their policies, they were aware of the memo and  were using this definition.

Memorandum that requires the military services and NCR to  submit copies of their reports on the implementation of  corrective actions to DHA. The Army’s draft policy that aligned with  DOD’s revised definition of sentinel events also included a section  requiring the submission of these reports to DHA. The policies of the  other military services and NCR do not include this requirement.  However, officials from the other military services we interviewed told  us that they are aware of this requirement and are submitting MOS  reports to meet this requirement. NCR officials told us that they are  aware of this requirement but have not begun submitting these  reports.

In March 2017, DOD’s senior military medical leadership published  operating principles to guide the implementation of specific MHS  requirements outlined in the NDAA 2017. One of the operating principles  to guide the transition of MTF administrative responsibilities to DHA  requires DHA to create all health care policies for the direct care system  (the MTFs) to ensure greater consistency and eliminate duplicative  governance. As a result, the military services and NCR will no longer be  establishing their own policies. According to DHA officials, the transition  for DHA to be the single policy writer for MTFs will take time, and policies  issued by the military services and NCR will remain in place until they are  superseded by revised DHA policies. DHA officials are in the process of  updating the department’s patient safety policy through the Patient Safety  Improvement Collaborative, a working group that includes patient safety  representatives from all of the military services, NCR, and DHA.  However, as of January 2018, DHA officials were uncertain as to when  this effort would be complete.

Fragmented Process for Tracking Sentinel Events and RCA Reports Impedes DHA’s Ability to Ensure It Has Received Complete Information

Process Used by the Military Services, NCR, and DHA to Track Sentinel Events and RCA Reports Is Fragmented

We found that the process used by the military services, NCR, and DHA  to track sentinel events is fragmented. (See fig. 5.) Similar to all other  types of adverse events, DHA requires that sentinel events be recorded in  the JPSR system. However, DHA officials told us there are additional  follow-up reports and associated deadlines for sentinel events that go  beyond the JPSR system’s current tracking capabilities, and as a result,  officials from each of the military services and NCR told us they track  sentinel events in their own tracking record outside of the JPSR system.  Officials told us the military services and NCR receive reports about  sentinel events from their MTFs via email, which are then entered in their  respective internal tracking records and reported to DHA via email. DHA  then enters and tracks the sentinel events in its own internal tracking  record. DHA officials told us that they do not believe that all sentinel  events are being entered in the JPSR system, and that the JPSR system  does not currently have the capability to pull sentinel event data for  tracking purposes. As a result, the same sentinel events are entered  and tracked in two separate tracking records—DHA’s tracking record and  the tracking records maintained by the military services or NCR.

In a similarly fragmented process, MTFs email RCA reports—a  requirement for sentinel events—separately to their respective military  services or NCR, which then emails them to DHA. Although DHA  requires MTFs to use a methodology currently supported by the TapRooT  system to complete their RCA reports, DHA officials told us the TapRooT  software is not compatible with most MTFs’ computer systems, and as a  result, MTFs do not share RCA reports through this system. Instead, they  told us MTFs use the methodology from the TapRooT system to prepare  the RCA report as a standalone document. Officials told us MTFs then  email the RCA reports to their military service or NCR, which notates the  RCAs in their respective internal tracking record. The military services  and NCR email the RCA reports to DHA, which notates the reports in its  own internal tracking record.

Fragmented Tracking Impedes DHA’s Ability to Ensure That It Has Complete Information on Sentinel Events and RCA Reports

Because the process used by the military services, NCR, and DHA to  track sentinel events and RCA reports is fragmented, DHA officials told us  they must rely on their reconciliation process to ensure they have  complete information. Specifically, on a monthly basis, DHA officials email  separate spreadsheets of DHA’s sentinel event records to each of the  military services and NCR requesting confirmation of reported sentinel  events and the status of overdue RCA reports, among other information.  DHA officials acknowledged that their reconciliation process is inefficient  and told us that their full-time employees and contractors spend an  average of 80 hours per month working on it. Additionally, officials told us  that sometimes information about sentinel events and RCA reports is lost  or not effectively communicated due to complexities related to routing the  email submissions and to turnover in the contract staff who track and  reconcile this information. The cooperation of the military services and  NCR is key to this process because officials told us that DHA currently  has no authority to compel a response from these entities, although this  may change with the transition of MTF administrative responsibilities to  DHA. DHA officials told us they sometimes do not receive a response to  their emails, and in these cases, DHA assumes concurrence.

In an effort to improve the reconciliation process and compliance with  RCA report submission requirements, DHA officials told us that they  developed a new tool called the Comprehensive Analysis Progress  Tracker for all three military services and NCR. DHA officials told us this  tracker shows the full cycle of each sentinel event, including which RCAs  are overdue, and is available on the MHS internal website. DHA officials  told us that this tracker, launched in October 2017, replaced the previous  system of separate monthly reconciliation emails with individual  spreadsheets for each military service and NCR. In January 2018, DHA  officials told us they began using this tracker at monthly Patient Safety  Improvement Collaborative meetings and will use it during monthly check-ins with the military services and NCR to discuss delayed or missing  items. However, the military services and NCR cannot directly edit the  Comprehensive Analysis Progress Tracker. As a result, DHA officials told  us that the military services and NCR will continue to use email to submit  their sentinel events and RCA reports as well as any corrections or  additional information needed for the tracker, which may perpetuate  previous inefficiencies.

Despite Reconciliation Efforts, DHA Does Not Have Complete Information on Sentinel Events and RCA Reports

Despite DHA’s efforts to reconcile its information on sentinel events and  RCA reports, we identified discrepancies and missing information in its  tracking record.

We found that the sentinel events in all of the military service and NCR  tracking records matched DHA’s tracking record except for those of the  Navy. Specifically, DHA had a record of 19 sentinel events that the Navy  did not have for 2013 through 2016. DHA officials were not sure of the  reason for the discrepancy between their tracking record and the Navy’s,  but told us that sometimes sentinel events are reported to DHA and later  determined to not be reportable, and DHA is not given the updated status  of the event. Navy officials told us that although they initially reported  these 19 events as sentinel, the Joint Commission informed the Navy that  it did not consider these events to be sentinel after reviewing the Navy’s  submission. Navy officials told us that they determined these events also  did not meet other sentinel event criteria per DHA’s revised definition,  which goes beyond the definition used by the Joint Commission. Further,  Navy officials told us they informed DHA that these events had been  deemed non-sentinel by the Joint Commission, and DHA’s tracking  record subsequently noted this. However, DHA did not remove the events  from its tracking record.

We found discrepancies in the number of RCA reports when comparing  DHA’s internal tracking record to the military services’ and NCR’s internal  tracking records. In some instances, we found that DHA had more RCA  reports in its tracking record than the military services or NCR for reported  sentinel events, and in other instances, DHA had fewer RCA reports in its  tracking record than the military services or NCR:

DHA had more RCA reports in its internal tracker than in the Army’s  internal tracker for 2015 (2 more) and 2016 (1 more).

DHA had fewer RCA reports than the Air Force in 2013 (3 less), 2014  (2 less), 2015 (13 less), and 2016 (1 less).

Additionally, DHA had fewer RCA reports for reported sentinel events  for NCR in 2015 (1 less) and 2016 (18 less).

Officials with the military services and NCR told us they did not know why  there were differences between their tracking records and those of DHA.  However, Army and NCR officials offered potential reasons for these  differences.

Army officials told us that they may have fewer RCA reports than DHA  because they recently transitioned their sentinel event and RCA  tracking record from a spreadsheet format to a database, and some  reports may not have been copied into the database.

NCR officials told us their tracking record may not match DHA’s  tracking record because an MTF may submit only one RCA report to  DHA that covers multiple similar sentinel events, so DHA may have  fewer reports documented in its internal tracking record.

For some reported sentinel events, we found that the required RCA  reports had not been recorded in any tracking record for the Army, NCR,  or DHA. (See table 3.)

Army and NCR officials told us that they did not know why they did not  have a record of an RCA report for every sentinel event in their internal  tracking record. However, these officials explained that there are a  number of potential reasons that RCA reports could be missing, including  insufficient MTF staff to carry out these activities, and MTF officials’  confusion about the revised definition of a sentinel event.

DHA officials told us that they did not know the reasons for the  discrepancies between the tracking records for the military services,  NCR, and DHA or for the missing RCA reports. Specifically, DHA officials  did not know whether these reports were completed but not submitted to  DHA or were not completed at all. They told us that they rely on the  cooperation of the military services and NCR to submit these reports and  cannot enforce the requirement, although this may change with the  transition of MTF administrative responsibilities to DHA. Because of these  discrepancies and missing RCA reports, DHA lacks critical information  about why a sentinel event may have occurred and what actions, if any,  MTFs should take to prevent similar incidents in the future.

We have previously reported that when fragmentation or overlap exists,  there may be opportunities to increase efficiency. In particular, our prior  work identified management approaches that may improve efficiency and  effectiveness, including implementing process improvement methods and  technology improvements. As MTF patient safety responsibilities are  transitioned to DHA, the fragmented tracking process may hamper DHA’s  ability to efficiently and effectively monitor sentinel events and RCA  reports, potentially leading to missed opportunities for systemic  improvements.

DHA’s Efforts to Ensure It Receives MOS Reports Are Limited and Impeded by Inconsistent Report Tracking and Unclear Requirements about Report Submission

DHA’s Efforts to Ensure It Receives MOS Reports Are Limited and Impeded by Inconsistent Report Tracking

As of September 2017, DHA had received 27 MOS reports for the 319  sentinel events that were reported in 2016. However, DHA does not know  how many reports it is missing because its efforts to reconcile information  for these reports have been limited. Prior to January 2018, DHA did not  include MOS reports as part of its reconciliation process for sentinel  events and RCA reports. However, in January 2018, DHA officials told us  they added MOS reports to their new monthly reconciliation process using  the Comprehensive Analysis Progress Tracker. While this tracker  displays the total number of MOS reports DHA has received, it does not  display whether individual reported sentinel events have an associated  MOS report. Without this information, DHA may be unable to identify  which MOS reports are missing. DHA officials told us that they may revise  the Comprehensive Analysis Progress Tracker to follow up on MOS  reports associated with specific sentinel events in the future.

DHA’s efforts to identify which MOS reports are missing are further  impeded by the military services’ and NCR’s inconsistent tracking efforts.  Specifically, the military services and NCR have been tracking the  submission of their MOS reports in different ways or not at all.

Army officials had told us that the completion of MOS reports was  noted in their internal tracking record for sentinel events and RCAs.  Army officials subsequently told us that as of January 2018, they  began tracking whether MOS reports were submitted to DHA in the  notes section of their internal tracking record.

Navy officials told us they indicated the due date of the MOS report  and the date of its submission to DHA in their internal tracking record  for sentinel events and RCA reports.

Air Force officials told us they indicated in their internal tracking record  for sentinel events and RCA reports the date that the MOS report was  sent to DHA. However, they told us the Air Force’s process for  tracking and submitting MOS reports to DHA has been inconsistent,  and they plan to revise it in the future.

NCR officials told us they did not track the completion of MOS reports  or their submission to DHA.

Because of these issues, DHA may not be able to fully reconcile its  information for individual MOS reports or identify the reports it is missing,  impeding its ability to obtain complete information on the effectiveness of  MTFs’ corrective action plans. This is inconsistent with federal internal  control standards, which require management to identify and respond to  risks to achieve its objectives, and for management to use quality  information to achieve its objectives.

DOD’s Requirement to Submit Reports on the Implementation of Corrective Actions Is Unclear

The requirement in DOD’s memo to submit reports on the implementation  of corrective actions is unclear, which may also impact DHA’s ability to  ensure that it is receiving these reports for all sentinel events. DHA  officials told us that MTFs could meet this requirement by submitting  copies of their MOS reports. According to the Joint Commission’s  guidance, the Joint Commission assigns MOS reports on an ad hoc  basis, depending on the sentinel event, RCA report, and corrective  actions, and as a result, an MOS report is not necessarily required for  each sentinel event.

DHA officials told us that they intended to obtain a report on the  implementation of corrective actions for every sentinel event, and they  believed that an MOS report was required and thus would be reported for  every sentinel event, similar to RCAs. However, DHA officials told us that  they learned from the military services and NCR at the January 2018  Patient Safety Improvement Collaborative meeting that an MOS report  was not required for every sentinel event and that DHA’s requirement for  submitting reports on the implementation of corrective actions was  unclear. Specifically, DHA officials told us the military services and NCR  told DHA that the 2015 memo did not state when the reports on the  implementation of corrective actions are required by DHA. For example,  the memo did not state whether DHA requires this report for a reported  sentinel event and RCA when the Joint Commission does not.

DHA’s unclear requirement is inconsistent with internal control standards,  which require management to review policies for continued relevance and  effectiveness in achieving the entity’s objectives. Under the current  policy, DHA cannot be sure it is receiving all reports on the  implementation of corrective actions—such as MOS reports—as it  intended, and therefore, it may be missing important information on the  effectiveness of MTFs’ implementation of their corrective actions that  could be used to help inform broader system-wide improvements. DHA  officials told us that they expect to clarify this requirement in DHA’s  update to its patient safety policy.

DHA Uses Information about Adverse Medical Events to Inform System-wide Patient Safety Improvement Initiatives

We found that DHA has introduced several system-wide patient safety  improvement initiatives informed by data on adverse medical events from  the JPSR system and data on sentinel events from DHA’s tracking  database, including the following:  DHA’s Partnership for Improvement. In January 2015, DHA  established an MHS-wide information technology system called the  Partnership for Improvement. The Partnership for Improvement collects  data from MTFs and assesses MTF performance on approximately 38  health care measures that were established by a committee of MHS  officials and designed to improve readiness, population health, and  quality of care as well as control costs. Three of these measures focus on  patient safety—central line-associated bloodstream infection, unintended  retained foreign object, and wrong site surgery. To track these  measures, DHA officials told us that they created an associated  performance dashboard, including acceptable ranges for each measure,  to provide visibility into MHS, military service-, and NCR-level  performance. The dashboard is available to all MHS users on the system  website and allows MTF leaders and staff to review MTF-level  performance data. DHA officials conduct quarterly system-wide  performance assessments on these measures. DHA officials told us they  use the data on this dashboard to determine what is improving and where  to make changes. Officials from each of the military services, NCR, and  each of the MTFs we visited told us they are aware of the Partnership for  Improvement and its associated dashboard and that they review the data  to assess their performance.

Publications on Patient Safety. DHA produces several types of  publications using adverse medical event and sentinel event data that  officials told us are generally distributed to MTFs through the military  services and NCR, including the following.

Patient Safety Data Snapshot. This monthly publication contains an  overview of adverse medical event and sentinel event data, trends  across the MHS, and short descriptions of sentinel events that have  been reported in the system in the same month. Additionally, this  publication may include reports of medical product deficiencies, or  materials that have been determined to be or are suspected of being  harmful, defective, deteriorated, or unsatisfactory because of  malfunction or design.

Annual patient safety report. This yearly publication provides a  retrospective status update on MHS patient safety initiatives and in- depth adverse event and sentinel event trend analysis, system-wide  and by military service. Content includes trends in adverse events  reported in JPSR, sentinel events, and RCAs, including information on  weaker, intermediate, and stronger corrective actions. This report also  describes progress on Partnership for Improvement measures  system-wide and by military service and NCR, the culture of patient  safety, and collaboration across DHA, the military services, and NCR.  The report also details online resources for MHS officials.

Focused review. According to officials, focused review publications  are produced three times a year, and the topics are related to adverse  medical events and associated follow-up data provided to DHA as  determined by data and performance trends. For example, in  September 2016, the publication included an explanation of the basic  components of an RCA, including their associated corrective actions  and factors DHA considers when determining if they are stronger,  intermediate, or weaker. This publication included 2013 through 2016  system-wide data, such as the number of RCAs submitted, the most  common root cause categories, and the proportion of RCAs with  stronger, weaker, or no corrective actions. The publication also  included an example of a decrease in occurrences of wrong-site  surgery accompanied by an improvement in RCAs with stronger  corrective actions, common pitfalls in conducting high-quality RCAs,  and recommendations to conduct better RCAs.

Patient safety alerts. DHA uses these publications to inform the  MHS about immediate hazards, and officials told us they produce  these publications on an as-needed basis. For example, a July 2016  report was focused on unintended retained foreign objects during  surgery, specifically, pieces of gloves. The publication described  recent occurrences of retained pieces of gloves, glove selection best  practices, tips for preventing unintended retention, and corrective  actions when retention occurs.

Global Trigger Tool. The Global Trigger Tool is a new tool for collecting  adverse medical event data by selecting a sample of medical charts that  was implemented MHS-wide as of September 2017. Unlike traditional  methods to detect adverse events, the Global Trigger Tool does not focus  on voluntary reporting and tracking of adverse medical events. Instead, a  team of three reviewers managed by DHA uses the tool methodology to  retrospectively examine a random selection of patient medical charts at a  facility over time to identify “triggers” (or clues) that may lead to an  adverse medical event. The 53 triggers include events such as a patient  fall or readmission to the emergency department within 48 hours of  treatment. If a trigger is discovered, the medical chart is further reviewed  to determine if an adverse event occurred. After the Global Trigger Tool  review is complete, the contractor is able to provide facility leaders with  rates of harmful adverse events per 1,000 patient days and per 100  admissions. Results from the tool are intended to aid MTFs in  understanding the true frequency of harm events and in identifying  systemic issues that contribute to patient safety events. All inpatient  MTFs across the MHS will use the tool, and implementation began in  2017. The Global Trigger Tool has just begun to provide data to the  MTFs, and DHA officials told us that 6 to 12 months of data is  recommended before the tool can be used to make improvements.

Sentinel Event and Root Cause Analysis (SERCA) tool. In October  2017, DHA released a dashboard called the SERCA tool, which DHA  officials told us will allow all MTF patient safety leaders to share lessons  learned in the course of sentinel event follow-up in real time. The SERCA  tool displays sentinel event and RCA data from DHA’s internal tracking  record reported by the military services and NCR. It is intended to provide  quick, online access to sentinel event trends MHS-wide and at the military  service, NCR, and MTF levels. The SERCA tool is also intended to  facilitate sharing of lessons learned and best practices based on sentinel  events and RCAs in a single platform. DHA officials told us that  individuals with access to the system will be able to see a breakdown of  corrective actions submitted by other MTFs for a particular type of  sentinel event and whether these corrective actions were rated as  stronger, intermediate, or weaker by DHA. DHA officials told us that for  now, they will allow the military services and NCR to determine who has  access to the system. Officials from two military services and NCR told us  that they have access to this tool and are responsible for granting access  to their MTFs. One MTF we visited told us they have access to this tool.  However, it is too early to evaluate how the SERCA tool will be used to  make improvements.

Each year, thousands of adverse medical events are reported at MTFs.  Tracking and conducting follow-up on these events is crucial for officials  to learn from and prevent these events in the future. As DHA assumes  administrative responsibility for all MTFs, its role in ensuring that sentinel  events—the most serious type of adverse medical events—are reported  and tracked and that required follow-up is conducted will become  increasingly critical. However, the current fragmented and inconsistent  tracking process across the military services and NCR has impeded the  efficiency of DHA’s efforts to ensure DHA has complete information about  sentinel events and RCA reports. Furthermore, DHA cannot ensure that it  is receiving all reports on the implementation of corrective actions, such  as MOS reports, and does not know how many reports it is missing for a  number of reasons, including those related to policy, tracking, and  reconciliation efforts. Collectively, all of these information gaps impair  DHA’s ability to fully understand the types of sentinel events that are  occurring in its MTFs, the corrective actions that have been implemented,  and whether these actions have been effective. This information is  essential to prevent adverse medical events from occurring in the future  and to ensure that the care provided by MTFs is safe and effective.

We are making the following two recommendations to the Assistant  Secretary of Defense (Health Affairs):

Ensure DHA improves as appropriate the systems and processes  used by the military services, NCR, and DHA to track sentinel events  and RCA reports and require the military services and NCR to  communicate with DHA the reasons RCA reports are not completed  for reported sentinel events. (Recommendation 1)

Ensure DHA clarifies its requirement that reports on the  implementation of corrective actions, such as MOS reports, should be  completed and submitted to DHA, and to work with the military  services and NCR to develop a standard system to help DHA  consistently track and reconcile information about individual reports.  (Recommendation 2)

DOD provided written comments on a draft of this report, including  technical comments, which we incorporated as appropriate. In its written  comments, which are reprinted in appendix II, DOD concurred with both  of our recommendations. In response to our first recommendation, DOD  acknowledged that its current tracking efforts for sentinel events and  RCAs are fragmented, inefficient, and unreliable. DOD stated that in the  future, it envisions a single system to track and monitor sentinel events,  RCAs, and corrective action implementation plan reports.  A single  system would eliminate the fragmentation associated with tracking these  reports and the need for a cumbersome reconciliation process, potentially  improving the completeness and reliability of DHA’s patient safety data as  well as its ability to identify and implement system-wide improvements.

In response to our second recommendation, DOD stated that it will clarify  the difference between an MOS report, which may be required by the  Joint Commission, and a corrective action implementation plan report,  which will always be required by DOD for reported sentinel events. DOD  explained that when an MOS report is required by the Joint Commission,  this report will satisfy DOD’s requirement.  However, when the Joint  Commission does not require an MOS report for a sentinel event, DOD  will require a corrective action implementation plan report.  DOD stated  that it expects the revised policy to be signed in late summer 2018 and in  effect by October 1, 2018—the date that DHA is to assume responsibility  for the administration of all MTFs.

We are sending copies of this report to the Secretary of Defense and  appropriate congressional committees. In addition, the report will be  available at no charge on GAO’s website at http://www.gao.gov.

If you or your staffs 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 can be found on the  last page of this report. Other major contributors to this report are listed in  appendix III.

Appendix I: Department of Defense’s (DOD) Revised Definition of a Sentinel Event

In a March 2015, the Assistant Secretary of Defense for Health Affairs  issued a memorandum about improving the sentinel event and root cause  analysis (RCA) reporting processes. This memorandum also revised  DOD’s definition of sentinel events, which previously stated that a sentinel  event is an unexpected occurrence involving death or serious physical or  psychological injury or risk. The revised sentinel event definition is a  patient safety event (not primarily related to the natural course of the  patient’s illness or underlying condition) that reaches a patient and results  in death, permanent harm, or severe temporary harm. This revised  definition also includes additional types of events outlined by the Joint  Commission and the National Quality Forum. (See table 4.)

DOD described the following sentinel events that are outlined by the Joint  Commission:

Suicide of any patient receiving care, treatment, and services in a  staffed around-the clock care setting or within 72 hours of discharge,  including from the hospital’s emergency department.

Unanticipated death of a full-term infant or discharge of an infant to  the wrong family.

Abduction of any patient receiving care, treatment, and services.

Any elopement (unauthorized departure) of a patient from a staffed  around-the-clock care setting (including the emergency department),  leading to death, permanent harm, or severe temporary harm to the  patient.

Destruction of red blood cells transfusion reaction involving  administration of blood or blood products that have major blood group  incompatibilities.

Rape, assault (leading to death, permanent harm, or severe  temporary harm), or homicide of any patient receiving care, treatment,  and services while on site at the hospital.

Invasive procedure, including surgery, on the wrong patient, at the  wrong site, or that is the wrong (unintended) procedure.

Unintended retention of a foreign object in a patient after an invasive  procedure.

Severe neonatal excess of bilirubin (bilirubin >30 milligrams/deciliter).

Prolonged fluoroscopy with cumulative dose >1,500 rads to a single  field or any delivery of radiotherapy to the wrong body region or >25  percent above the planned radiotherapy dose.

Fire, flame, or unanticipated smoke, heat, or flashes occurring during  an episode of patient care.

Any maternal death or severe maternal or morbidity occurring during  or after birth (24 hours).

Appendix II: Comments from the Department of Defense

Appendix III: GAO Contact and Staff Acknowledgments

In addition to those named above, key contributors to this report were:  Bonnie Anderson, Assistant Director; Danielle Bernstein, Analyst-in- charge; Jacquelyn Hamilton; Elizabeth T. Morrison; Vikki Porter; and  Helen Sauer.

Medical errors, system vulnerabilities, or process failures can permanently or temporarily harm—or kill—patients. In military health facilities, it's critical to track and analyze these "sentinel events" to help prevent them in the future.

The military services and the Defense Health Agency both track such events. Agency officials told us they spend 80 hours a month reconciling their records with the military services, but in some instances, the records don't match. The agency may be missing opportunities to make military health care safer. We recommended improving the tracking of sentinel events and follow-up requirements.

Question: What is impeding the Defense Health Agency's ability to ensure that it has received complete information?

Answer: GAO found that the process for tracking the most serious adverse medical events, called sentinel events, and their root cause analysis (RCA) reports are fragmented, impeding the Defense Health Agency's (DHA) ability to ensure that it has received complete information.

Question: What differentiates sentinel events from other medical events?

Answer: Unlike other adverse medical events, sentinel events—which may result in severe harm or death—have additional reporting requirements that must be met within specified time frames. For example, military treatment facility (MTF) officials must develop RCA reports, which identify causal factors and corrective actions for sentinel events.

Question: To what extent does the DHA track such information?

Answer: However, because the database that DHA uses to collect information on adverse medical events does not currently have the capability to track this information, the military services (Army, Navy, and Air Force) and DHA each maintain their own tracking records for sentinel events and RCA reports. Due to these fragmented tracking efforts, DHA reconciles its information on sentinel events and RCA reports through monthly emails to the military services—a time-consuming, inefficient process. DHA officials emphasized that this process relies on the military services' cooperation because DHA does not currently have the authority to compel their responses.

Question: What did GAO identify about DHA's tracking record?

Answer: Moreover, despite DHA's reconciliation efforts, GAO identified discrepancies and missing information in DHA's tracking record. As a result, DHA lacks critical information about why a sentinel event may have occurred and what actions, if any, MTFs should take to prevent similar incidents in the future.

Question: How has DHA attempted to address such problems?

Answer: Recently, DHA replaced its previous system of emails with a new tracker tool that can be accessed on the military health system website.

Question: What is the extent of the success of this new tracker?

Answer: However, the new tracker does not allow the military services to make edits, and as a result, any corrections or additional information must be submitted to DHA via email, which may perpetuate previous inefficiencies.

Fragmented Process for Tracking Sentinel Events and RCA Reports Impedes DHA’s Ability to Ensure It Has Received Complete Information

Fragmented Tracking Impedes DHA’s Ability to Ensure That It Has Complete Information on Sentinel Events and RCA Reports

Despite Reconciliation Efforts, DHA Does Not Have Complete Information on Sentinel Events and RCA Reports

DHA’s Efforts to Ensure It Receives MOS Reports Are Limited and Impeded by Inconsistent Report Tracking and Unclear Requirements about Report Submission

DHA’s Efforts to Ensure It Receives MOS Reports Are Limited and Impeded by Inconsistent Report Tracking

Question: What was discovered by GAO about DHA's ability to receive reports on the implementation of corrective actions identified in RCA reports?

Answer: GAO found that DHA cannot ensure that it is receiving all reports on the implementation of corrective actions identified in RCA reports as required by a March 2015 memo. HA officials stated that MTFs could meet this requirement by submitting copies of their measures of success (MOS) reports, which may be required by the Joint Commission, a hospital accrediting organization.

Question: What characterizes DHA's use of the MOS reports thus far?

Answer: As of September 2017, DHA had received 27 MOS reports for the 319 sentinel events that were reported in 2016. However, DHA does not know how many reports it is missing because MOS reports are not required for every sentinel event, and DHA did not began reconciling its information for these reports until January 2018, when it implemented its new tracker tool. Furthermore, GAO found that the new tracker tool documents the aggregate number of MOS reports received and does not indicate whether individual sentinel events have an MOS report, impeding DHA's ability to identify which reports are missing.

Question: What is the experience of military officials using the tracker?

Answer: This issue is compounded by the fact that the military services either track MOS reports in different ways or not at all, and military service officials said that DHA's requirement for MOS report submission is not clear.

Question: What is the likely consequence of this missing information?

Answer: Because it is unable to ensure it has received all reports on the implementation of corrective actions, DHA could be missing important information that could be used to help inform broader, system-wide patient safety improvement efforts.

Question: How has DHA responded to this issue?

Answer: DHA officials stated that they expect to clarify this requirement in their update to the patient safety policy.

DOD’s Requirement to Submit Reports on the Implementation of Corrective Actions Is Unclear

Question: What provision for the GAO did the NDAA 2017 include, in regards to medical events?

Answer: The NDAA 2017 included a provision for GAO to examine the reporting and resolving of adverse medical events in the military health system.

Question: What are two of the objectives that the report reviews?

Answer: Among other objectives, this report reviews (1) the extent to which sentinel events and RCA reports are tracked and DHA ensures it has received complete information, and (2) the extent to which DHA ensures it has received MOS reports.

Question: How did GAO collect information for the report?

Answer: GAO examined relevant policies; analyzed the most current available data on sentinel events from 2013 through 2016; and interviewed officials with DHA, the military services, and four MTFs selected for variety in military service, size, and geographic location.

Transition of MTF Administrative Responsibilities to DHA