United States Government Accountability Office Report to Congressional Committees MILITARY HEALTH August 2022 CARE Improved Procedures and Monitoring Needed to Ensure Provider Qualifications and Competence GAO-22-104668 August 2022 MILITARY HEALTH CARE Improved Procedures and Monitoring Needed to Ensure Provider Qualifications and Competence Highlights of GAO-22-104668, a report to congressional committees Why GAO Did This Study What GAO Found Since 2014, Congress and the The Defense Health Agency is responsible for ensuring the quality and safety of Department of Defense (DOD) have health care delivered by individual providers at its military medical treatment taken steps intended to strengthen facilities. However, GAO found that four selected facilities and the Defense patient safety in the Military Health Health Agency did not always adhere to the agency's clinical quality System. As part of those efforts, management procedures in part because they were unclear. Congress mandated that the Defense Health Agency, an agency within DOD, • Credentialing and privileging. GAO reviewed documentation for 100 be responsible for the military providers from four selected facilities and found that the facilities did not departments' administration of always adhere to the Defense Health Agency's procedures for credentialing facilities. This responsibility includes and privileging-the process of verifying that a provider has the appropriate ensuring individual providers are qualifications and abilities to deliver specific health care services. For qualified and competent to deliver safe, example, for about one-sixth of providers reviewed, the facilities did not verify high quality care to patients. all medical licenses before granting privileges. Additionally, for almost half of Congress included a provision in the providers reviewed, the facilities did not obtain clinical references from statute for GAO to review the Defense appropriate individuals such as the program director, as required. GAO found Health Agency's clinical quality this was partly due to the procedures being unclear about which providers management procedures. This report must have clinical references. addresses facilities' and the Defense Health Agency's adherence to these • Focused evaluations of concerns. The four selected facilities collectively procedures and the Defense Health conducted 20 focused evaluations to address clinical performance concerns Agency's monitoring of facilities' raised about individual providers. GAO's review showed that these facilities adherence. GAO reviewed did not always adhere to requirements. For example, for about half of these documentation from four facilities evaluations, facilities did not document the metrics for evaluating whether selected to obtain variation in location providers adequately addressed the concerns raised. GAO found that and military department. Additionally, nonadherence was due in part to unclear procedures, such as inconsistent GAO reviewed the Defense Health terminology for these evaluations. Agency's clinical quality management procedures and interviewed relevant Defense Health Agency officials about • Patient safety events that resulted in compensation. GAO found that the these procedures and related Defense Health Agency did not always adhere to its own requirements for monitoring efforts. GAO also evaluated reviewing patient safety events. Patient safety events, such as the the procedures and monitoring efforts misdiagnosis of a life-threatening condition, can involve compensation using federal internal control because of the potential for patient harm. The four selected facilities had 12 standards. such events that resulted in compensation to patients or their families. Specifically, the Defense Health Agency's reviews of nine of these events What GAO Recommends exceeded the required time limits for those reviews. Also, the Defense Health GAO is making two recommendations, Agency did not report providers involved in those nine events to a national to the Defense Health Agency to (1) database as required. clarify its clinical quality management GAO also found that the Defense Health Agency did not sufficiently monitor procedures and (2) conduct monitoring facilities' adherence to its clinical quality management procedures. As of May to better ensure facilities adhere to 2022, the Defense Health Agency monitored adherence to some credentialing these procedures. DOD concurred with and privileging requirements by running database reports on expired credentials, both recommendations. but did not monitor adherence to other requirements, such as certain performance evaluations. Defense Health Agency officials told GAO they have developed plans to monitor facilities' documentation of focused evaluations and View GAO-22-104668. For more information, patient safety events, but had not yet implemented these plans. contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov. United States Government Accountability Office Contents Letter 1 Background 4 Selected MTFs Did Not Always Adhere to Certain DHA Requirements for Credentialing and Privileging Providers 9 Selected MTFs Did Not Always Adhere to DHA Requirements for Conducting FPPEs for Cause 14 Selected MTFs Did Not Always Adhere to Certain DHA Requirements for Conducting PCE Reviews 18 DHA Did Not Always Adhere to DHA Requirements for Reviewing Patient Safety Events That Resulted in Compensation 21 DHA Monitoring of MTFs' Adherence to Its Requirements for Clinical Quality Management Is Insufficient 24 Conclusions 26 Recommendations for Agency Action 27 Agency Comments 28 Appendix I Objectives, Scope, and Methodology 29 Appendix II Comments from the Department of Defense 33 Appendix III GAO Contact and Staff Acknowledgements 36 Figures Figure 1: Adherence to Certain DHA Credentialing and Privileging Requirements for a Sample of Providers from Four Selected MTFs 10 Figure 2: Rate of Adherence to Certain DHA Requirements in 20 FPPEs for Cause at Four Selected MTFs 15 Page i GAO-22-104668 Military Health Care Abbreviations DHA Defense Health Agency DOD Department of Defense FPPE focused professional practice evaluation MTF military medical treatment facility NPDB National Practitioner Data Bank OPPE ongoing professional practice evaluation PCE potentially compensable event This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately. Page ii GAO-22-104668 Military Health Care Letter 441 G St. N.W. Washington, DC 20548 August 11, 2022 The Honorable Jack Reed Chairman The Honorable James M. Inhofe Ranking Member Committee on Armed Services United States Senate The Honorable Adam Smith Chairman The Honorable Mike Rogers Ranking Member Committee on Armed Services House of Representatives The Defense Health Agency (DHA) supports the delivery of health care to beneficiaries, including service members and their families, at military medical treatment facilities (MTF), which include 49 military hospitals and hundreds of health and dental clinics. These health care services are delivered by physicians, dentists, and other providers and range from routine examinations to complex surgical procedures. In 2014, news articles highlighted concerns about medical errors and lapses in patient safety at MTFs. For example, they identified failures to review serious patient safety events, which are incidents that could have resulted or did result in harm to a patient, such as the misdiagnosis of a life-threatening condition. 1 In August 2014, the Department of Defense (DOD) released a review of the Military Health System that addressed patient safety, among other issues. 2 DOD's review concluded that the Military Health System 1Sharon LaFraniere,"Military Hospital Care Is Questioned; Next, Reprisals," The New York Times (Dec. 20, 2014) accessed March 17, 2022, https://www.nytimes.com/2014/12/21/us/military-hospital-care-is-questioned-next- reprisals.html?_r=1 and Sharon LaFraniere and Andrew Lehren,"In Military Care, A Pattern of Errors but Not Scrutiny" The New York Times (June 28, 2014) accessed March 14, 2022, https://www.nytimes.com/2014/06/29/us/in-military-care-a-pattern-of-errors-but- not-scrutiny.html. 2Department of Defense, Final Report to the Secretary of Defense MHS Review (Washington, D.C.: Aug. 29, 2014). Page 1 GAO-22-104668 Military Health Care generally provided safe, quality, and timely care, but noted considerable variation across its MTFs. Congress and DOD have since taken steps intended to strengthen accountability, transparency, and standardization in the Military Health System. In particular, Congress mandated that the Director of DHA is to be responsible for the administration of each MTF no later than September 30, 2021. 3 DHA issued standardized clinical quality management procedures, which are requirements intended to help ensure that individual providers are qualified and competent to deliver safe, high-quality care to patients across the three military departments (Air Force, Army, and Navy). 4 While some aspects of the transition to DHA administration are still ongoing, the new DHA procedures took effect October 1, 2019. The National Defense Authorization Act for Fiscal Year 2020 included a provision for GAO to assess aspects of DOD's clinical quality management program, including its procedures for reviewing the quality and safety of providers' care. 5 In December 2020, we described DHA's procedures for preventing and responding to quality and safety concerns about providers delivering care to patients at MTFs. 6 Additionally, in March 2022, we testified before the House Armed Services Committee's Military Personnel Subcommittee on our preliminary observations from this review. 7 In this report, we examine 3See 10 U.S.C. § 1073c. 4See Department of Defense, Defense Health Agency, Defense Health Agency Procedures Manual 6025.13: Clinical Quality Management in the Military Health System, Volumes 3: Healthcare Risk Management and 4: Credentialing and Privileging (Falls Church, Va.: Aug. 29, 2019). In December 2020, we issued a report describing DHA's processes for preventing and responding to quality and safety concerns about individual health care providers at MTFs, including this DHA procedures manual. See GAO, Military Health Care: Defense Health Agency Procedures for Responding to Provider Quality and Safety Concerns, GAO-21-160R (Washington, D.C.: Dec. 1, 2020). 5Pub. L. No. 116-92, § 747, 133 Stat. 1198, 1473-1474 (2019). 6See GAO, Military Health Care: Defense Health Agency Procedures for Responding to Provider Quality and Safety Concerns, GAO-21-160R (Washington, D.C.: Dec. 1, 2020). 7See GAO, Military Health Care: Preliminary Observations on DOD's Monitoring of Provider Qualifications and Competence, GAO-22-105890 (Washington, D.C.: Mar. 30, 2022). Page 2 GAO-22-104668 Military Health Care 1. selected MTFs' adherence to DHA credentialing and privileging requirements; 2. selected MTFs' adherence to DHA requirements for conducting evaluations of providers whose delivery of care has raised concerns; 3. selected MTFs' adherence to DHA requirements for reviewing providers involved in potentially compensable events; 4. DHA's adherence to its requirements for reviewing patient safety events that resulted in compensation to patients or their families; and 5. DHA's monitoring of MTF adherence to these requirements for clinical quality management. To examine MTFs' and DHA's adherence to DHA requirements, we reviewed relevant DHA procedures. 8 We interviewed relevant officials from DHA and each of the military departments about DHA procedures and assessed these procedures against federal internal control standards for control activities. 9 We selected four MTFs that varied based on factors such as geographic location and military departments. For each of the four MTFs, we reviewed MTF documentation of these procedures for individual providers and assessed it for adherence to the DHA requirements. We also interviewed relevant staff from each of the four MTFs. To examine DHA's monitoring of these procedures, we interviewed relevant officials, reviewed DHA's documentation, and assessed it against federal internal control standards related to monitoring. 10 See appendix I for additional details on our methodology, including how we selected MTFs and providers for our review. We conducted this performance audit from December 2020 to August 2022 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 8As of March 2022, the military departments continued to support implementation of certain clinical quality management procedures in their respective MTFs, including performing some of the DHA responsibilities for patient safety events that result in compensation. However, because DHA ultimately has the authority and responsibility for implementation of the procedures, we generally refer to DHA in this report. 9GAO, Standards for Internal Control in the Federal Government, GAO-14-704G (Washington, D.C.: Sept. 2014). Internal control is a process effected by an entity's oversight body, management, and other personnel that provides reasonable assurance that the objectives of an entity will be achieved. 10GAO-14-704G. Page 3 GAO-22-104668 Military Health Care that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. Background Transition to DHA Between October 2019 and March 2021, all three of the military Procedures for Clinical departments continued to support DHA by administering MTFs' implementation of the DHA procedures for clinical quality management. Quality Management Army and Air Force provided such support to DHA until March 2021 and October 2021, respectively. As of May 2022, Navy continued to provide support and will continue to do so until DHA is ready to assume full responsibility, which is expected no later than October 2022. Credentialing and Credentialing and privileging is an important process through which Privileging health care organizations gain assurance that providers are qualified and competent to deliver care. 11 During credentialing, MTF staff verify that a provider's professional credentials-such as medical licenses-are valid and appropriate for their requested clinical privileges. During privileging, MTF staff review these credentials and qualifications and grant permission and responsibility to a health care provider to perform specified health care services at the MTF, such as performing moderate or deep sedation. The initial appointment, or privileging cycle, typically lasts 1 year; subsequent privileging cycles may not exceed 24 months. As part of credentialing and privileging, MTF staff review the following types of information, among others: Provider medical licenses. Medical licenses are issued by state licensing boards. Before MTFs initially grant privileges, MTF staff must verify that each provider has at least one current, valid, active, and unrestricted license and that any additional licenses held by a provider, including inactive and expired licenses, are also in good standing. After privileges are granted, MTF staff must also verify that licenses that would expire during the privileging cycle are renewed, or allowed to expire in good standing if the provider has another active license. 11In December 2011, we made eight recommendations to improve credentialing and privileging in the Military Health System. DOD implemented four of the recommendations, and four recommendations remain unimplemented. See GAO, DOD Health Care: Actions Needed to Help Ensure Full Compliance and Complete Documentation for Physician Credentialing and Privileging, GAO-12-31 (Washington, D.C.: Dec. 15, 2011). Page 4 GAO-22-104668 Military Health Care National database queries. As part of the credentialing and privileging process, MTF staff query databases that may contain potentially adverse information about individual providers, including the following: • National Practitioner Data Bank (NPDB). The NPDB is an electronic repository administered by the U.S. Department of Health and Human Services that collects and releases information on providers such as those who have been disciplined by a state licensing board or have malpractice claims history. 12 The presence of information in the NPDB does not necessarily disqualify a provider from employment in the Military Health System. Instead, the credentials committee-a group of MTF staff responsible for making recommendations to MTF leadership on matters related to credentialing and privileging-must consider the potentially adverse information and assess whether it is appropriate to grant (or renew) the provider's privileges. • Department of Health and Human Services List of Excluded Individuals and Entities. This database tracks providers who are excluded from employment under federally funded health care programs for a variety of reasons, such as a conviction for Medicare fraud or patient abuse. Unlike the NPDB, appearing on the List of Excluded Individuals and Entities automatically disqualifies a provider from federal employment in any capacity, including in the Military Health System. Provider performance. MTF staff collect and review information about providers' performance to inform privileging decisions in a variety of ways, including the following: • Clinical references. Providers must each obtain two written references from individuals who can attest to their skills and qualifications. For certain types of providers, DHA requires the references to be completed by certain individuals, such as a military training program director. 12Established by Congress in 1986, the NPDB is a workforce tool that prevents practitioners from moving state to state without disclosure or discovery of previous damaging performance. The NPDB collects and releases information on providers who have been disciplined by a state licensing board, professional society, or health care entity, such as a hospital, or have been named in a medical malpractice settlement or judgment, among other things. The NPDB also includes providers who have been named in an active-duty death or disability payment. Industry standards call for health care entities to query the NPDB to determine if a provider has a history of substandard care and misconduct before appointing a provider to the entity's medical staff and when renewing clinical privileges. Page 5 GAO-22-104668 Military Health Care • Initial focused professional practice evaluations (FPPE). When a provider receives new privileges at an MTF, the provider must undergo a period of enhanced performance monitoring. 13 • Ongoing professional practice evaluations (OPPE). Providers who have successfully completed their initial FPPEs are moved to routine ongoing monitoring, referred to as an OPPE. • Performance assessments. MTF clinical supervisors must complete performance appraisals for each provider at the end of each privileging cycle. Performance assessments are based on OPPEs, or initial FPPEs for new providers, and inform decisions on renewing a provider's privileges. Focused Professional When concerns about a provider's clinical competence arise, such as Practice Evaluations for from a patient complaint or involvement in a patient safety event, MTFs may choose to place the provider on an FPPE for cause, a period of Cause enhanced monitoring. According to the DHA procedures manual, FPPEs for cause are not adverse in nature; rather, they are intended to help providers improve their skills in response to concerns. A provider who improves performance during the FPPE for cause may return to the routine ongoing monitoring cycle of OPPEs. However, if the provider fails to meet performance criteria, the FPPE for cause may be extended or, if concerns are significant, may result in an adverse privileging action, such as restriction or removal of privileges. DHA requires MTFs to document certain elements of the FPPE for cause plans and the evaluation outcome. For example, there must be an initial written plan documenting the duration or volume of the FPPE for cause; the metrics and criteria that will be used to evaluate the provider's performance; and who has been assigned as the preceptor, a clinical peer who evaluates the provider's clinical practice. The DHA procedures manual also requires the preceptor to provide regular written feedback to the provider and monthly updates to the credentials committee. Potentially Compensable During the course of providing health care, patient safety events- Event Reviews incidents that could have resulted or did result in harm to a patient-may 13This period of enhanced monitoring, referred to as an FPPE, may also be used to evaluate individual providers' performance when concerns are raised about the quality or safety of care that they deliver. When conducted for this reason, we refer to the evaluation as an FPPE for cause. Page 6 GAO-22-104668 Military Health Care occur. 14 DHA's health care risk management procedures include requirements for reviewing providers involved in certain patient safety events, referred to as potentially compensable events (PCE). Specifically, MTF staff must conduct PCE reviews for every patient safety event (1) that reaches a patient-regardless of whether the patient was harmed- and (2) for which an MTF risk assessment determines there is a likelihood of financial loss to the government. Such potential compensation includes an active-duty disability or death payment to a service member or their family, or payments associated with a potential or filed malpractice claim. 15 During the PCE review, MTF staff identify providers who were significantly involved in the event and determine whether each of these providers delivered care that was consistent with standards. 16 DHA requires MTF staff to document information about the PCE review, such as the date of the event and the status of the review, in the centralized health care risk management database. MTF staff are required to commence the PCE review within 30 days of the notification date-the date they become aware that the event occurred-and must complete the PCE review within 180 days of the same notification date. Additionally, 14According to DHA procedures, the term "patient safety event" includes adverse events, no-harm events, near miss events, and unsafe conditions. Adverse events are events that resulted in harm to the patient, and may occur by either the omission or commission of medical care. DHA defines no-harm events as events that "reach" (i.e. involve) the patient, but did not cause harm. Near miss events are events that did not reach the patient. Unsafe conditions are conditions or circumstances other than a patient's own disease process or condition that increases the probability of an adverse event. DHA requires consideration of PCE reviews for adverse events and no-harm events. 15Active-duty service members who become retired or separated from service for physical disability may receive a disability payment as compensation. Similarly, when active-duty service members die, their beneficiaries may receive death benefit payments as compensation. A medical malpractice claim could be filed, for example, if during the course of treatment, a provider deviates from accepted norms of practice and causes or contributes to an injury to or death of the patient. Although any beneficiary could file a medical malpractice claim, prior to enactment of the National Defense Authorization Act of Fiscal Year 2020, DOD could only settle and pay such claims filed by or on behalf of non- active-duty service member patients, such as family members. The law was changed to allow DOD to settle and pay such claims filed by or on behalf of active-duty service members on or after January 1, 2020. Pub. L. No. 116-92, § 731, 133 Stat. 1198, 1457- 1460 (2019). Implementing regulations are at 32 C.F.R. Part 45, effective July 19, 2021. 16Standard of care determinations are based on the established standards of health care delivery at the time of the event, and may be based on professional literature, professional organization or society publications, facility policies and processes, and applicable health care laws. Page 7 GAO-22-104668 Military Health Care DHA requires MTF staff to consider actions against the significantly involved providers at two points in the review: • First, at the initiation of the review, MTF staff must document consideration of whether the event warrants an investigation for adverse privileging action, which involves removing the provider from patient care and potentially reducing or revoking the provider's privileges to deliver health care. • Second, if the completed review determines that the provider did not meet the standard of care, the credentials committee must consider additional actions, such as an adverse privileging action or placing the provider on an FPPE for cause. This credentials committee review is the final MTF step in the PCE review process for all cases that do not result in compensation. 17 Patient Safety Events That If a patient safety event results in compensation to patients or their Result in Compensation families for medical malpractice or an active-duty service member's death or disability, information from the PCE review is used to inform whether DHA reports a significantly involved provider to the NPDB. 18 The NPDB guidebook calls for reporting individual providers who were named in a medical malpractice payment to the NPDB within 30 days of the payment. 19 Pursuant to a 1992 agreement between DOD and the Department of Health and Human Services-the agency that administers the NPDB- DHA procedures call for the agency to report providers who were significantly involved in an event that resulted in compensation, but only if the agency's review of the case determines that the providers deviated 17For cases involving active-duty service members, additional procedures are required if the MTF standard of care review finds that a provider did not meet the standard of care and, as a result, the patient was harmed but a death or disability payment will be delayed. In those cases, DHA policy establishes additional procedures for potentially reporting the provider before the payment is made. 18DHA's procedures refer to "medical tort" claims, while the NPDB repository of reports contains information on "medical malpractice" payments. For the purpose of this report, we use these term synonymously. 19U.S. Department of Health and Human Services, Health Resources and Services Administration, Bureau of Health Workforce. National Practitioner Data Bank Guidebook (Rockville, Md.: October 2018), accessed March 3, 2022, https://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp. Page 8 GAO-22-104668 Military Health Care from the standard of care. 20 For events resulting in compensation, DHA must conduct additional steps to inform this reporting decision, and must do so within 270 days of payment or notification of payment; this time frame includes a 90-day extension to accommodate backlogs due to the COVID-19 pandemic and to the transition to DHA administration of MTFs. 21 These steps depend on the MTF's standard of care determination. • If the MTF determined that the provider met the standard of care, DHA must obtain an external civilian peer review to provide a second opinion. If the external reviewer also finds that the provider met the standard of care, the case may be closed. • If either the MTF or external review determines that the provider did not meet the standard of care, then a DHA panel of clinicians reviews the case and recommends whether to report the provider to the NPDB. The four selected MTFs did not always adhere to credentialing and Selected MTFs Did privileging requirements, which are intended to help ensure that providers Not Always Adhere to are qualified and competent. Specifically, the four selected MTFs did not always verify all medical licenses, conduct providers' performance Certain DHA assessments, or query national databases before granting providers Requirements for privileges, in accordance with requirements in the DHA procedures manual. For example, for 19 of our sample of 99 providers, staff at the Credentialing and selected MTFs did not query the Department of Health and Human Privileging Providers Services List of Excluded Individuals and Entities. 22 Querying this list could identify information disqualifying a provider from employment in the Military Health System, before granting privileges to deliver health care. 20DHA officials said the reason for the agreement between DOD and the Department of Health and Human Services is that payments, such as for malpractice claims, arising from health care provided by DOD providers are adjudicated against the United States government, not any individual health care providers who may have been involved. 21The DHA procedures manual requires DHA to report all significantly involved providers to the NPDB within 180 days of payment notification, unless DHA has made a final determination that the outcome was not caused or contributed to by the failure of the provider to meet the standard of care. However, in the context of the COVID-19 pandemic and the transition of responsibility from the military departments to DHA, DOD issued a waiver extending the deadline to 270 days from the date of payment or notification of payment for cases that would have reached the 180-day threshold between October 1, 2020 and March 31, 2022. 22The specific number of providers we reviewed for each requirement varied depending on the type of provider and the applicability of each requirement. Therefore, the number of providers we reviewed for each requirement does not always equal 100. Page 9 GAO-22-104668 Military Health Care See Figure 1 for how frequently the selected MTFs adhered to the DHA requirements for credentialing and privileging. Figure 1: Adherence to Certain DHA Credentialing and Privileging Requirements for a Sample of Providers from Four Selected MTFs Notes: We selected a non-generalizable sample of 25 providers who were granted privileges to deliver health care from October 2019 to August 2021 at each of the four selected MTFs, for a total of 100 providers. We reviewed MTFs' documentation of credentialing and privileging procedures for these providers to assess adherence to DHA requirements. The specific number of providers we reviewed for each requirement varied depending on the type of provider and the applicability of each requirement. Therefore, the number of providers we reviewed for each requirement does not always equal 100. Page 10 GAO-22-104668 Military Health Care a In addition to these 15 providers, there were four providers for whom we were unable to assess adherence to this requirement because the individuals completing the clinical reference form did not indicate their relationship to the providers. The following examples illustrate additional details from our analysis about when the selected MTFs did not adhere to certain DHA requirements for credentialing and privileging. Active licenses. The selected MTFs did not verify all of a provider's medical licenses before granting privileges, as required by DHA, for 13 of the 98 providers we reviewed. For four of these 13 providers, the MTFs could not provide documentation that staff verified any licenses before granting a provider privileges. The remaining nine of the 13 providers held active licenses in multiple states, and the MTFs verified at least one-but not all-of them before granting privileges. For example, one provider held 10 medical licenses, but the MTF only verified eight of those licenses before granting privileges. For some of the 13 providers, the MTFs failed to verify licenses because the providers did not disclose all of their licenses. 23 When MTFs do not verify all licenses, they risk being unaware of an action taken against an unverified license. Renewed licenses. The selected MTFs did not verify 20 of 35 provider license renewals at the time when the licenses were scheduled to be renewed by the state licensing board, as required by DHA. In these cases, the license renewal did not coincide with the end of the privileging cycle, but instead occurred between privileging cycles. Without verifying that a provider's license was renewed at the scheduled time, including in between privileging cycles, MTFs allow providers to deliver care without current information about the status of their licenses. Clinical references. The selected MTFs did not obtain two clinical references, as required, for about one-third of the applicable providers in our review. The manual is unclear regarding whether clinical references are required when renewing privileges for existing providers. 24 Staff across all four selected MTFs also shared different responses when asked about adherence to this requirement, including uncertainty if 23MTF officials said they may not be aware of a license if a provider does not disclose it. For example, state license boards may list licenses that the provider holds in other states. We discovered providers in our review who did not disclose all licenses based on our review of documentation provided by the MTF. 24Specifically, the section of the procedures manual on clinical references only includes requirements for new providers. However, the manual also includes a table that indicates clinical references are required for renewal of privileges. Page 11 GAO-22-104668 Military Health Care clinical references were required before granting privileges. 25 However, DHA officials confirmed that two clinical references are required for all providers and acknowledged that the procedures manual could be clearer with regard to clinical references. Without clarifying the requirement that MTFs must obtain two clinical references for all providers, DHA increases its risk that MTFs cannot make informed decisions about the qualifications and competence of providers they privilege. Furthermore, eight out of 19 new providers did not provide references from required individuals. For example, some providers who joined the MTFs from civilian training programs did not provide references from the program director and a senior level staff provider. In addition, for four of the 19 providers, the individuals completing the clinical reference form did not clearly indicate their relationship to the providers. Without ensuring that the clinical references are completed by the appropriate individuals, MTFs may lack important first-hand information on the providers' performance. Ongoing professional practice evaluations. For 42 of 56 providers we reviewed, the selected MTFs did not conduct and document OPPEs every 6 months, as required by DHA. In some of these instances, MTFs documented some, but not all, of the OPPEs that were required during the prior privileging cycle. In other instances, MTFs did not provide documentation of any OPPEs for a given provider. Without conducting and documenting OPPEs, MTFs risk making privileging decisions without the necessary information on providers' performance. Officials from three of the four selected MTFs said that because of the requirement for ongoing and repeated documentation of OPPEs, it can be challenging for clinical staff such as physician supervisors to complete all of the paperwork in a timely manner. 26 To better adhere to this requirement, staff from some of the selected MTFs described plans to 25Staff from one of the selected MTFs also stated that they do not obtain clinical references for providers renewing their privileges; rather, they use the otherwise required performance assessment as a substitute for clinical references because, in their opinion, it captures the equivalent clinical competence information as the clinical references. 26Some MTF staff experienced similar challenges obtaining completed performance evaluations from clinical staff, such as supervisors. While the selected MTFs adhered to the requirement to complete performance assessments 90 percent of the time, we found that certain sections of the forms were sometimes not complete. Page 12 GAO-22-104668 Military Health Care improve the OPPE process such as standardizing performance monitoring schedules and hiring additional staff to track adherence. We also identified a lack of specificity in the DHA procedures manual that may increase the risk of MTFs granting privileges to unqualified or incompetent providers. The DHA procedures manual lacks specificity regarding the time frames for verifying medical licenses and querying national databases and documentation of MTFs' consideration of any concerns raised. Time frames for verifying medical licenses and querying national databases. The DHA procedures manual requires MTFs to verify medical licenses and query the List of Excluded Individuals and Entities and NPDB before privileges are granted. However, the manual does not specify how far in advance these procedures can be conducted. Our analysis showed variation in when the selected MTFs verified medical licenses and queried the List of Excluded Individuals and Entities database. For five providers, MTFs verified medical licenses more than 6 months before granting privileges. Similarly, for four providers, MTFs queried the List of Excluded Individuals and Entities database more than 6 months before granting privileges. For some of these nine providers, the MTF verified the medical license and queried the national database more than a year before privileges were granted. MTFs that conduct these procedures too far in advance risk missing timely discovery of new adverse information about a provider that arises between the MTF performing these checks and granting privileges. This includes information that could disqualify the provider from working at the MTF. Documentation of MTFs' consideration of any concerns raised. The DHA procedures manual states that the credentials committee must convene to review any provider applications or files that raise quality, safety, or other concerns. DHA officials told us they expect MTFs to document that the credentials committee considered this information but have not specified this expectation in the procedures manual. Accordingly, we found that the selected MTFs did not always document consideration of such concerns. For example, one MTF did not document its consideration of a provider's performance assessment from another MTF that raised significant concerns about the provider's competence and also indicated that the provider had resigned from the other MTF. In another instance, a provider's clinical reference was completed by an individual who had last observed the provider's performance nearly 10 years earlier. MTF officials confirmed that the 10-year time period would raise concerns. In the absence of documentation, it was not clear that Page 13 GAO-22-104668 Military Health Care MTF staff had considered or were aware of this information when granting privileges to these providers. The absence of documentation is inconsistent with federal internal control standards, which call for agencies to design appropriate types of control activities, such as documentation of significant events, to achieve objectives and respond to risks. 27 In terms of clinical quality management, significant events can include concerns that were raised during credentialing and privileging. In the absence of documentation, an MTF credentials committee's consideration of this potentially adverse information may not be readily available for making informed decisions about a provider's qualifications and competence to provide safe, high- quality care. This lack of available information could be particularly concerning in the Military Health System, where providers frequently transfer from one MTF to another. 28 The four selected MTFs did not consistently adhere to DHA requirements Selected MTFs Did for FPPEs for cause-that is, focused evaluations of providers about Not Always Adhere to whom concerns had been raised. We reviewed all 20 FPPEs for cause initiated by the four selected MTFs between October 1, 2019 and March DHA Requirements 1, 2021. For five of 10 requirements, our review showed that MTFs for Conducting adhered to DHA procedures less than half the time. 29 (See Figure 2.) Because of this inconsistent adherence, DHA lacks reasonable FPPEs for Cause assurance that FPPEs for cause are having their intended effect of validating providers' clinical competency and providing them opportunities for learning and improvement. 27GAO-14-704G. 28In our December 2011 report on DOD credentialing and privileging, we had a similar finding and recommendation regarding DOD not requiring MTFs to document their consideration of significant events during their reviews of credentials files. Despite issuing new standardized procedures, DOD has not taken action to implement this recommendation. See GAO-12-31. 29In 14 of the 20 cases we reviewed, the provider successfully returned to OPPE status (i.e., routine monitoring). Of the remaining six cases, one ended in the provider's resignation, two resulted in initiation of adverse privileging actions against the providers, two did not have clearly documented outcomes, and one was still ongoing at the time of our review. Page 14 GAO-22-104668 Military Health Care Figure 2: Rate of Adherence to Certain DHA Requirements in 20 FPPEs for Cause at Four Selected MTFs Notes: For all procedures, we reviewed documentation from all 20 FPPEs for cause with start dates between October 1, 2019, and March 1, 2021 conducted by our four selected MTFs. We assessed the documentation for these FPPEs for cause for adherence to the DHA procedures manual. a The preceptor is the clinical peer who evaluates the provider's clinical practice. b Volume includes such information as the number of cases to be reviewed, such as 10 cases per quarter. c Duration is a length of time, such as 60 days. Page 15 GAO-22-104668 Military Health Care d Metrics identify what activity or skill is being monitored, such as timely recording of notes from patient encounters. e Criteria specify the acceptable level of performance on the metrics by the provider to complete the FPPE, such as recording notes within 72 hours for 100 percent of patient encounters. f The credentials committee is a group of MTF staff responsible for making recommendations to MTF leadership regarding issues of credentialing and privileging, including FPPEs for cause. Importance of FPPEs for cause (case Two key DHA requirements for FPPEs for cause were infrequently study) implemented among selected MTFs: documentation of metrics and The importance of focused professional criteria. MTFs are required to include these two sections in the written practice evaluations (FPPE) for cause is plans for each FPPE in order to make clear to the provider and preceptor illustrated by one case we reviewed in which serious concerns about a provider's basic what skills they must focus on for the provider to be deemed successful in competence arose. The provider was placed completing these evaluations. 30 on an FPPE for cause due to wide-ranging concerns covering diagnostic ability, knowledge of medications, expression of • In nearly half of cases we reviewed, MTFs failed to document the empathy, and more. Clinical staff notes state metrics for assessing provider performance in their written FPPE that over the course of the FPPE, the provider regressed clinically and displayed poor plans. Metrics identify what activity or skill is being monitored, such as judgment. Clinical staff eventually deemed the timely recording of notes from patient encounters. provider unable to safely see patients. Ultimately, the facility suspended this • MTFs failed to document criteria in roughly two-thirds of the cases we provider's privileges. Source: GAO analysis of Department of Defense military reviewed. Criteria establish the acceptable level of performance to treatment facility documentation. | GAO-22-104668 complete the FPPE for cause, such as recording notes within 72 hours for 100 percent of patient encounters. In the absence of clearly defined metrics and criteria for success, providers and their preceptors may not focus on the areas in which concerns were raised, and the provider may be returned to regular performance monitoring before areas of concern are adequately addressed. One MTF that developed its own template for FPPE for cause written plans adhered to requirements more consistently than the other three selected MTFs. For example, this MTF documented the reason for every FPPE for cause we reviewed, as required, while the remaining three selected MTFs did not. 31 However, some required procedures were not included in this MTF's template. This MTF adhered to the procedures not included in its template-documenting metrics, documenting criteria, and including both chart review and direct observation in the monitoring 30At the start of each FPPE for cause, MTFs must compile a written plan documenting not only metrics and criteria, but also such information as the name of the preceptor, the reason for the FPPE for cause, and the volume or duration of the evaluation. The preceptor is the clinical peer who evaluates the provider's clinical practice. 31The other three MTFs documented the reason for half of the 10 FPPEs they conducted during the period of our review. Page 16 GAO-22-104668 Military Health Care plan-no more often than the other MTFs. As of January 2022, DHA officials confirmed they had not developed an FPPE for cause plan template to be used agencywide, but were considering doing so. Additionally, we found deficiencies in the records for FPPE for cause documentation across all four selected MTFs. Specifically, we found that these MTFs did not document the outcome of the FPPE for cause, as required, in eight of the 20 cases we reviewed. Nor did preceptors consistently provide the required regular feedback to the provider and updates to the credentials committee. For only seven of the 20 cases did we find that providers received written feedback while on these evaluations. The credentials committee received monthly written updates on the providers' progress for only eight of the 20 providers. 32 According to the DHA procedures manual, the credentials committee is responsible for reviewing FPPEs for cause and is to use these monthly updates to decide at each monthly meeting whether to return the provider to OPPE, extend the FPPE for cause, or summarily suspend the provider. Without monthly updates, the credentials committee may not have the necessary information to make this evaluation. Selected MTFs' inconsistent adherence to FPPE for cause requirements may be partially due to unclear terminology in the DHA procedures manual. Specifically, the DHA procedures manual does not always make a clear distinction between requirements that apply to initial FPPEs- used to evaluate all new providers-and those that apply to FPPEs for cause-used to evaluate providers about whom concerns have been raised. Some portions of the procedures manual imply that an "FPPE with monitoring and evaluation" is another term for an FPPE for cause; other sections use the same term to refer to initial FPPEs. This inconsistent use of terms makes it difficult to understand which requirements apply to each type of evaluation. When asked, DHA officials clarified that FPPE with monitoring and evaluation is only intended to refer to FPPEs for cause, but they acknowledged that the current procedures manual uses the same term to refer to initial FPPEs. Officials stated that they intend to remove this ambiguity in a future revision to the manual. Without this clarification, MTF staff may not complete necessary steps to investigate concerns about a provider's performance. Further, some MTF staff reported finding the current DHA procedures manual confusing or unclear. For example, staff at one MTF felt that the 32For another six providers, the committee received updates for some but not all months. Page 17 GAO-22-104668 Military Health Care procedures manual did not make it clear when or whether MTFs are allowed to extend FPPEs for cause or what should happen if a provider is deemed unready to return to OPPE at the end of the FPPE for cause. Staff at another MTF stated that much of the DHA procedures manual was vague. The four selected MTFs did not always adhere to certain DHA Selected MTFs Did requirements for 19 completed reviews of potentially compensable events Not Always Adhere to (PCE). These PCE reviews focus on the care delivered by providers who were significantly involved in patient safety events that MTF risk Certain DHA assessments determined were likely to result in possible compensation to Requirements for patients or their families. 33 Conducting PCE • Two of the selected MTFs did not complete any PCE reviews because Reviews they failed to conduct the required credentials committee review of the standard of care determinations, the last step for the MTF in the PCE review process. • The other two MTFs completed PCE reviews and adhered to some DHA procedures, such as conducting and documenting standard of care reviews. We found that the two selected MTFs that completed PCE reviews did not adhere to DHA requirements in two key areas: 1) documenting consideration of actions that the MTF could take against significantly involved providers and 2) conducting PCE reviews within the required time frames. Documentation of actions considered. The two selected MTFs that completed PCE reviews did not always adhere to DHA procedures for documenting their consideration of actions that the MTF could take for significantly involved providers, including adverse privileging actions and FPPEs for cause. Specifically, DHA requires consideration of such actions at two key points in the PCE review process-the initiation of every PCE review and the completion of the standard of care review, if 33We reviewed documentation of 19 completed PCE reviews conducted by two of the selected MTFs on patient safety events that occurred between October 1, 2019 and March 1, 2021 and that the selected MTFs determined may result in future compensation to patients or their families, but had not resulted in compensation at the time of our review. The two MTFs completed seven and 12 PCE reviews, respectively. The 19 PCE reviews included 43 significantly involved providers, 40 of whom the MTFs determined met the standard of care in the corresponding events. These 19 PCE reviews did not include cases that resulted in compensation-that is, medical malpractice, active-duty death, or active-duty disability payment. Page 18 GAO-22-104668 Military Health Care the provider did not meet the standard of care. The two MTFs did not document whether they considered removing a provider from patient care and taking adverse privileging actions against any of the 43 providers at the initiation of the 19 completed PCE reviews. While such actions may be limited to rare instances of egregious patient safety events, the procedures manual specifies that the decision for or against such action must be documented for every PCE, which helps to ensure that MTFs are considering appropriate actions for each case. Conversely, for the three providers (out of the 43 in our review) who did not meet the standard of care, the selected MTFs did adhere to the DHA requirement to document the consideration of adverse privileging action or other actions, such as FPPE for cause. 34 Timeliness of PCE reviews. The MTFs also did not always adhere to DHA timeliness requirements for commencing and completing the PCE reviews. The two MTFs commenced five of the 19 completed PCE reviews within 30 days of the notification date, as required. However, we identified two PCE reviews that were commenced 84 and 109 days after notification, respectively, and one MTF did not clearly document the commencement dates for the remaining 12 PCE reviews. 35 Further, the selected MTFs did not always complete the 19 PCE reviews within 180 days of notification, as required. 36 Specifically, the number of days from notification to completion ranged from 91 to 546, with more than 80 percent of the PCE reviews we examined exceeding 180 days. For one of the MTFs, which was responsible for 12 of the 16 reviews that exceeded 180 days, the delay was largely due to staff's lack of awareness of the DHA requirement to conduct the credentials committee 34Specifically, one MTF documented that one of the three providers had already completed an FPPE for cause at the time the credentials committee reviewed the standard of care determination. For the other two providers who did not meet the standard of care, the MTFs documented their decisions not to take additional action. 35We were unable to determine the commencement date for the other 12 completed PCE reviews because the MTF that conducted these reviews did not routinely enter information into the centralized database at the beginning of the PCE review. As a result, the date the MTF created the record did not reflect the date the MTF commenced the PCE review. 36In addition to the 19 completed reviews, we also identified 23 ongoing PCE reviews that had exceeded the 180-day completion requirement at the time of our analysis. The amount of time since the MTFs had been notified of these events to the time of our analysis ranged from 183 to 540 days, with an average of 327 days. Twelve of the 23 ongoing reviews were from the two MTFs that did not have any completed PCE reviews due to the lack of credentials committee review. Page 19 GAO-22-104668 Military Health Care review. Staff at this MTF said they completed all 12 reviews when they became aware of this requirement in mid-calendar year 2021. We found that the selected MTFs' nonadherence to PCE review timeliness requirements was due in part to a lack of clarity in the DHA procedures manual and inadequate tools for documenting the required PCE review information. Specifically, DHA requires MTFs to commence PCE reviews within 30 days of notification but has not defined when a PCE review is considered commenced. Further, the centralized database is not designed to systematically capture and document the date commencement occurs. While the database includes a field that captures the notification date, it does not include a specific field for the commencement date. DHA and some MTF officials said the date the MTF creates the record for the PCE review in the database would represent the commencement date; however, we did not find this to be the case for 12 of the 19 PCE reviews. Similarly, while DHA requires completing the PCE review within 180 days of notification of the event, we found that DHA has not defined when a PCE is considered completed by the MTF. Further, while the credentials committee review is the last step for a PCE review that is specified in the procedures manual, the database does not include a field for capturing the date of this review. When asked, DHA officials said MTFs should use a field that captures the MTF standard of care review date to calculate the number of days to completion. However, according to the DHA procedures manual, the standard of care review is not the MTF's last step in the process, and thus the cases would not be complete at that time. As noted above, some MTFs were not aware of the requirement to conduct the credentials committee review, which had implications for their ability to complete the PCE review. Further, we found that the selected MTFs used the database field for the MTF standard of care review date inconsistently. Of the two MTFs with completed PCE reviews, one MTF generally used this field to capture the date the standard of care review was complete for all significantly involved providers, while the other MTF generally used this field to capture the date of the credentials committee review. As a result, the centralized health care risk management database does not accurately capture the PCE review completion date and DHA does not have reasonable assurance that MTFs are conducting PCE reviews in a timely manner. Page 20 GAO-22-104668 Military Health Care DHA did not always adhere to the DHA requirements for reviewing 12 DHA Did Not Always patient safety events that occurred at the selected MTFs and resulted in Adhere to DHA compensation to patients or their families. Specifically, DHA did not always (1) complete its reviews within required time frames or (2) report Requirements for providers to the NPDB when reviews exceeded time frames, as required Reviewing Patient under DHA procedures. Safety Events That Timeliness. Our review of documentation indicated that DHA did not Resulted in complete its required review in a timely manner for nine of the 12 patient safety events from the four selected MTFs that resulted in Compensation compensation. 37 • For three of these nine cases, DHA completed its review more than 270 days after the date of payment, which is inconsistent with the DHA requirement. The amount of time elapsed from payment to completion ranged from 301 to 467 days for these three reviews. 38 • For the other six cases, DHA had not completed its required reviews at the time of our review. The payments in these ongoing cases were made between 420 and 746 days before DHA provided us with information in February 2022. 39 Our review of the documentation for the 12 patient safety events that resulted in compensation indicated that delays occurred at the DHA level. Specifically, we found that the selected MTFs generally completed their standard of care reviews for these 12 cases in about 90 days or less. However, the amount of time elapsed from completion of the MTFs' reviews to initiation of the DHA reviews ranged from 27 to 642 days, with an average of about 348 days. Moreover, in half of the 12 cases, DHA initiated its reviews after our inquiry about the status of these patient 37DHA is required to report all significantly involved providers to the NPDB within 180 days of payment notification, unless DHA has made a final determination that the outcome was not caused or contributed to by the failure of the provider to meet the standard of care. However, for cases that would have reached the 180-day threshold between October 1, 2020, and March 31, 2022, DOD issued a waiver extending the deadline to 270 days from the date of payment or notification of payment. 38DHA's review of six of the 12 cases was complete at the time of our review. For all six of these completed cases, the external review corroborated the MTF-level determination that the significantly involved providers met the standard of care, and DHA closed the cases without a report to the NPDB. 39At that time, five of these cases were pending completion of the required external review. One case, which involved a provider who the MTF determined did not meet the standard of care, was pending completion of the required review by a DHA panel of clinicians. Page 21 GAO-22-104668 Military Health Care safety event reviews. In all six of these cases, the MTF-level standard of care review had been completed more than a year before the DHA review was initiated. We found that multiple factors contributed to the delays in DHA's reviews of the patient safety events that resulted in compensation. First, DHA officials said that they lacked adequate staffing to process these cases during the transition of responsibility for administration of the MTFs from the military departments to DHA. DHA officials said that this issue was exacerbated by the COVID-19 pandemic. Officials told us in March 2022 that they had improved their capacity to process these cases by hiring and training new staff, as well as obtaining contractor support. Second, DHA lacks a process to obtain and evaluate complete information about patient safety events that resulted in compensation and thus require DHA review. DHA officials described challenges to obtaining information about all active-duty death and disability payments that resulted from health care, including obtaining access to this information from other entities within DOD. DHA officials stated that most active-duty death and disability payments are not related to health care and thus do not require MTFs to conduct a PCE review or DHA to review the case. DHA officials told us that identifying the cases that were related to health care would require a clinician to review cases individually, which is a resource-intensive task that would have to be conducted by staff with clinical expertise. DHA officials stated in May 2022 that they are committed to addressing the logistical challenges to obtaining and evaluating complete information about all patient safety events that resulted in compensation. In addition, although DHA has taken some steps to obtain information about active-duty death and disability payments, challenges remain. In May 2022, DHA officials said they were considering requesting access to information about active-duty deaths from the Office of the Under Secretary of Defense for Personnel and Readiness, which maintains this information, particularly now that DHA had the clinical staff to conduct these reviews. DHA officials also said that in April 2022 they obtained data on all existing active-duty disability payments and evaluated whether DHA was notified about the payments when they were associated with patient safety events. While DHA officials told us in April 2022 that they had identified an additional 71 active-duty death and nine active-duty disability cases, these efforts are neither comprehensive nor ongoing. In the meantime, DHA officials continue to rely on information that MTF staff enter into the centralized database, which our review found is not always Page 22 GAO-22-104668 Military Health Care complete. DHA officials said that failure by the MTFs to enter complete information into the database contributed to their lack of awareness of some of the cases and delays in completing their reviews. DHA's lack of a process to obtain and evaluate complete information about patient safety events that result in compensation, and thus require DHA review, is inconsistent with federal internal control standards for information and monitoring. 40 According to federal internal control standards, management needs a way to identify and obtain relevant data to be able to meet their objectives. Once management obtains the complete and accurate data, it can be used for evaluations and oversight to further help them achieve their objectives. Without obtaining and monitoring the DOD data on patient safety events that result in compensation, DHA lacks awareness of whether MTFs are appropriately reviewing the care delivered by providers who were involved in these events and whether additional DHA reviews are needed. NPDB reporting. We also found that DHA did not report the nine providers to the NPDB for whom the headquarters-level review exceeded 270 days, as required. Specifically, the DHA procedures manual states that if a final reporting decision has not been made within 270 days of the payment, DHA must report the provider to the NPDB immediately. 41 DHA officials indicated in March 2022 that they had submitted a request to the DOD Office of the Assistant Secretary for Health Affairs for an additional waiver to retrospectively extend the amount of time that DHA is allowed before being required to report these providers to the NPDB. Officials said they were seeking this waiver to avoid reporting providers to the NPDB due to DHA's administrative delays that the providers cannot control. As of May 2022, the Office of the Assistant Secretary for Health Affairs had not approved the waiver. DHA officials emphasized that if any providers are determined to have not met the standard of care at the completion of the headquarters review procedures, officials would report these 40GAO-14-704G. 41The DHA procedures manual requires DHA to report all significantly involved providers to the NPDB within 180 days of payment notification, unless DHA has made a final determination that the outcome was not caused or contributed to by the failure of the provider to meet the standard of care. However, in the context of the COVID-19 pandemic and the transition of responsibility from the military departments to DHA, DOD issued a waiver extending the deadline to 270 days from the date of payment or notification of payment for cases that would have reached the 180-day threshold between October 1, 2020 and March 31, 2022. Page 23 GAO-22-104668 Military Health Care providers in accordance with the procedures manual. However, in the absence of either obtaining a waiver or reporting these providers, DHA is not adhering to its procedures manual. When DHA does not complete the required reviews of patient safety events that result in compensation, and do so in a timely manner, DHA is not fulfilling its responsibility to report to the NPDB providers who may have delivered substandard care that resulted in an active-duty death, active-duty disability, or medical malpractice payment. 42 Further, DHA's failure to report providers in a timely manner to the NPDB may hinder other health care organizations' efforts to obtain complete information about providers' involvement in these patient safety events when granting them privileges. DHA does not sufficiently monitor MTFs' adherence to its requirements DHA Monitoring of for clinical quality management, including credentialing and privileging, MTFs' Adherence to FPPEs for cause, and PCE reviews. While DHA has taken some steps to begin monitoring adherence since the implementation of the procedures Its Requirements for in October 2019 and officials expect to expand on these efforts, DHA's Clinical Quality current monitoring is insufficient and additional monitoring has not yet been implemented. Management Is Insufficient Credentialing and privileging. DHA did not monitor MTFs' adherence to credentialing and privileging requirements between October 2019 and fall 2021. 43 Since the fall of 2021, DHA has taken some steps to improve its monitoring efforts, but does not yet review MTF adherence to certain procedures. 44 42As noted above, pursuant to a 1992 agreement between DOD and the Department of Health and Human Services-the agency that administers the NPDB-DHA procedures call for the agency to report providers who were significantly involved in an event that resulted in payment, but only if the agency's review of the case determines that such providers deviated from the standard of care. This is different from other health care entities that report to the NPDB all providers involved in patient safety events for which payments are made, regardless of whether the providers' care caused or contributed to the event. 43DHA officials told us that between October 2019 and fall 2021, they primarily consulted with and educated MTFs by holding monthly meetings with MTF staff, providing training to new MTF staff, and responding to questions from MTF staff about the procedures. 44DHA officials also noted that they may conduct site visits and review documents not found in the database if they identify deficiencies in their monitoring of the database or if an MTF requests a visit, however these visits are not routine. Page 24 GAO-22-104668 Military Health Care For example, DHA officials stated that in the fall of 2021 they began reviewing reports generated from the centralized database on the number of certain types of credentials, such as licenses, that are expired. After reviewing these reports, DHA officials said they also conduct a more in- depth monthly review of the credentials records extracted from the database for a sample of providers. However, DHA cannot use reports from the centralized database to monitor initial FPPEs or OPPEs because MTFs are not required to enter information on these requirements into the database. This is particularly concerning given the low rate of adherence that we identified among the selected MTFs for OPPEs. In May 2022, DHA officials reported plans to update the DHA procedures manual to require MTFs to upload documentation of FPPEs and OPPEs to the centralized database and estimated that this revision would go into effect in the fall of 2022. 45 Focused professional practice evaluations for cause. DHA did not monitor MTFs' adherence to FPPE for cause requirements from October 2019 until at least March 2022. 46 In April 2022, DHA officials told us they developed a tool for monitoring information about FPPEs for cause. DHA's monitoring tool captures information such as the end date of each FPPE for cause, the reasons for the evaluations, and presence of written plans documenting clear measures for success. However, DHA has not indicated plans to monitor MTF adherence to other key FPPE for cause requirements, such as monthly written updates to the credentials committee or documentation that the provider received written notification of the FPPE outcome. Further, DHA lacks complete information to monitor FPPEs for cause because these evaluations are maintained at the MTF-level. Like initial FPPEs, FPPEs for cause are not required to be entered into the centralized database by MTF staff. DHA officials indicated plans to revise the procedures manual to begin requiring MTFs to enter this information and estimated that this requirement will go into effect in fall of 2022. In the 45Additionally, the military departments-including Navy, which as of May 2022 was still responsible for supporting DHA's monitoring-also conducted limited monitoring of MTF adherence to DHA credentialing and privileging procedures. Officials from Army and Navy reported having conducted additional monitoring activities prior to the transition to DHA management. For example, Army officials reported they had previously conducted audits of MTFs' credentialing and privileging documentation but have discontinued these efforts since the MTF management responsibility transitioned to DHA. 46We also found no evidence that individual military departments had monitored MTF implementation of FPPE for cause requirements prior to the transition of responsibility to DHA. Page 25 GAO-22-104668 Military Health Care interim DHA officials said they must rely on individual MTFs to send them information about providers on FPPEs for cause. As of April 2022, officials said they are monitoring providers on FPPEs for cause who were returned to practice following adverse privileging action procedures, a subset of the providers on these evaluations. Potentially compensable event reviews. From October 2019 through March 2022, DHA officials said that their office was ramping up capacity and had not begun monitoring PCE reviews. In April 2022, DHA officials said they were developing a dashboard tool for monitoring information about PCE reviews, to be implemented in May 2022. Officials indicated that the dashboard would allow them to monitor information such as the number and status of PCE reviews at each MTF. DHA officials said that they planned to use the tool to select a sample of PCE reviews to audit for adherence to the DHA procedures later in 2022. 47 However, DHA did not share details about what types of adherence would be reviewed. Further, until this monitoring approach is fully implemented, DHA relies on the MTFs to implement the procedures for PCE reviews appropriately. DHA's insufficient monitoring of MTFs' adherence to its requirements for clinical quality management is inconsistent with federal internal control standards for monitoring, which state that management should establish and operate monitoring activities, as well as evaluate issues and remediate deficiencies. 48 In the absence of adequate monitoring, DHA lacks assurance that MTFs are adhering to procedures to ensure providers are competent to provide quality care and that all concerns about individual providers are addressed; this increases risks to patient safety. Additionally, without monitoring MTFs' implementation of the procedures, DHA may be missing an opportunity to identify areas in which the MTFs may be struggling to implement the DHA procedures. DHA is responsible for ensuring that providers in its MTFs are qualified Conclusions and competent to deliver health care services to service members and their families, as well as ensuring that concerns about providers' clinical care are reviewed and addressed. Our review shows that four selected MTFs did not always adhere to DHA's procedures for credentialing and 47DHA officials described plans to conduct this monitoring through its market offices, which are responsible for groups of MTFs in geographic areas. 48GAO-14-704G. Page 26 GAO-22-104668 Military Health Care privileging, FPPEs for cause, and PCE reviews. We found a lack of clarity in DHA's procedures manual and insufficient monitoring of MTFs contributed to this lack of adherence. DHA has taken some steps to address the monitoring deficiencies we identified in our review. However, DHA's monitoring approach will not be fully implemented until later in 2022. DHA's insufficient monitoring also highlights the need to hold MTFs accountable for ensuring that providers are qualified and competent. DHA only recently assumed the military departments' responsibilities for administration of MTFs and the implementation of the new DHA procedures manual. With these new responsibilities, it is critical that DHA address deficiencies in clinical quality management to ensure that health care providers at MTFs are qualified and competent to deliver safe, high- quality care to service members and their families. We are making the following two recommendations to DHA: Recommendations for Agency Action The Director of the Defense Health Agency should revise the procedures manual for clinical quality management to better ensure requirements are clear and specific. Revisions should • clarify whether clinical references are required for providers whose privileges are being renewed. • specify how far in advance of privileging an MTF is allowed to verify licenses and query the NPDB and List of Excluded Individuals and Entities. • specify that MTF staff must document their consideration of information that raises concerns during the credentialing and privileging process. • clarify requirements for FPPEs for cause, including clear distinctions between requirements that apply to initial FPPEs and those that apply to FPPEs for cause. • specify how DHA defines commencing and completing a PCE review and how MTFs should document these milestones in DOD's centralized healthcare risk management database. (Recommendation 1) The Director of the Defense Health Agency should implement monitoring of clinical quality management procedures at MTFs and ensure that the monitoring approach includes Page 27 GAO-22-104668 Military Health Care • an assessment of MTF adherence to credentialing and privileging, FPPE for cause, and PCE review procedures. • a process for obtaining and evaluating information about all patient safety events that resulted in compensation and require DHA review. (Recommendation 2) We provided a draft of this product to DOD for review and comment. In its Agency Comments written comments, reproduced in appendix II, DOD concurred with both recommendations. We will send copies of this report to the appropriate congressional committees, the Secretary of Defense, and other interested parties. In addition, the report will be available at no charge on GAO's website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or SilasS@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix III. Sharon M. Silas Director, Health Care Page 28 GAO-22-104668 Military Health Care Appendix I: Objectives, Scope, and Appendix I: Objectives, Scope, and Methodology Methodology We selected four military medical treatment facilities (MTF) to analyze adherence to the Defense Health Agency (DHA) procedures for all five of our objectives. We selected these four MTFs to include representation from each of the military departments and geographical distribution. 1 Each of these selected MTFs also had at least 100 providers, such as physicians and dentists, who were privileged to deliver health care services. 2 To examine MTFs' adherence to DHA credentialing and privileging requirements, we reviewed credentialing and privileging documentation for a non-generalizable sample of 100 providers across the four MTFs. We selected a non-generalizable sample of 25 privileged providers from each MTF to include variation in appointment type (including military, civilian, and contract providers) and clinical specialties (such as family medicine and surgery). We also included some providers who were receiving privileges at the MTFs for the first time and some who already held privileges, as well as some providers who were on a temporary appointment from another MTF. For the selected providers, we assessed MTF documentation for adherence to the DHA procedures for nine credentialing and privileging procedures, such as verifying individual providers' medical licenses and reviewing performance evaluations. The specific number of providers we reviewed for each requirement varied depending on the type of provider and the applicability of each procedure. Therefore, the number of providers we reviewed for each requirement does not always equal 100. We also interviewed relevant staff from selected MTFs about their implementation of the credentialing and privileging procedures. Finally, we assessed DHA's credentialing and privileging procedures against federal internal control standards related to control activities. 3 1When we selected MTFs in early 2021, DHA was responsible for administering clinical quality management procedures for two MTFs; the three military departments were each supporting DHA by continuing to administer clinical quality management for their respective MTFs. We selected one MTF from each. 2To inform our MTF selection, DHA and each of the military departments provided data on the number of privileged providers at each MTF as of January 2021, and the number of PCEs that were initiated by each MTF between October 1, 2019, and December 31, 2020. 3GAO, Standards for Internal Control in the Federal Government, GAO-14-704G (Washington, D.C.: Sept. 2014). Internal control is a process effected by an entity's oversight body, management, and other personnel that provides reasonable assurance that the objectives of an entity will be achieved. Page 29 GAO-22-104668 Military Health Care Appendix I: Objectives, Scope, and Methodology To examine MTFs' adherence to DHA requirements for conducting evaluations of providers whose delivery of care has raised concerns, we reviewed MTF documentation of all focused professional practice evaluations (FPPE) for cause that were conducted by the four selected MTFs and initiated between October 1, 2019, and March 1, 2021. 4 The MTF documentation we reviewed generally included the plan developed at the start of the FPPE, monthly progress updates, and the final evaluation of the provider's performance on the FPPE for cause. We assessed MTF documentation for adherence to the DHA requirements. Further, we interviewed MTF staff regarding their implementation of the FPPE for cause procedures. To examine MTFs' adherence to DHA requirements for reviewing providers involved in potentially compensable events (PCE), we identified all PCE reviews that were conducted by the four selected MTFs on patient safety events that occurred between October 1, 2019 and March 1, 2021. We assessed MTF documentation of PCE reviews that were complete at the MTF level at the time of our review for adherence to the applicable DHA requirements. 5 Because MTFs are required to complete their PCE reviews within 180 days of the notification date of the event, we limited our review to cases for which the MTF was notified at least 180 days before our review, which ranged from December 2020 to March 2021. Further, we interviewed MTF staff regarding their implementation of the PCE review procedures. To examine DHA's adherence to its requirements for reviewing patient safety events that resulted in compensation to patients or their families, we identified patient safety events that occurred at the four selected MTFs between October 1, 2019, and March 1, 2021, that resulted in an active-duty death, active-duty disability, or medical tort, such as malpractice, payment. We analyzed PCE reviews of patient safety events that resulted in compensation separately because DHA procedures specify additional requirements for DHA review of these cases. We reviewed both DHA's and military departments' implementation because, at the time of our review, the military departments were continuing to support implementation of the DHA clinical quality management 4Each of the MTFs identified the list of providers that had been on FPPEs for cause during this time. We ensured the lists were complete by reviewing MTF documentation. 5We did not assess adherence for PCE reviews that were ongoing at the time we conducted our work to avoid any real or perceived influence on the outcome of cases that were still undergoing review. Page 30 GAO-22-104668 Military Health Care Appendix I: Objectives, Scope, and Methodology procedures manual in their respective MTFs, including in some cases performing the DHA responsibilities for patient safety events that resulted in compensation. However, because DHA ultimately has the authority and responsibility for implementation of the procedures, we generally refer to DHA in this report. Because DHA is required to complete its review of cases involving payments within 270 days of the date a payment is made, which includes a 90-day extension to accommodate backlogs due to the DHA transition and the COVID-19 pandemic, we limited our review to cases for which the payment date was at least 270 days before our review in February 2022. That is, we reviewed cases with a payment date between October 1, 2019 and May 10, 2021. 6 We reviewed documentation of these cases and interviewed DHA about their reviews. We also evaluated DHA's procedures against federal internal control standards related to information and monitoring. 7 Finally, to examine DHA's monitoring of MTF adherence to credentialing and privileging, FPPE for cause, and PCE reviews, we interviewed officials from DHA, the DOD's Office of the Assistant Secretary for Health Affairs, the three military departments, and the four selected MTFs. We also reviewed documentation of DHA's monitoring. We evaluated the information we received against federal internal control standards related to monitoring. 8 We conducted this performance audit from December 2020 to August 2022 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 6The DHA procedures manual requires DHA to report all significantly involved providers to the National Practitioner Data Bank within 180 days of payment notification, unless DHA has made a final determination that the outcome was not caused or contributed to by the failure of the provider to meet the standard of care. However, in the context of the COVID- 19 pandemic and the transition of responsibility from the military departments to DHA, DOD issued a waiver extending the deadline to 270 days from the date of payment or notification of payment for cases that would have reached the 180-day threshold between October 1, 2020 and March 31, 2022. Our scope included cases that would have reached the 270-day threshold before February 4, 2022, the date on which DHA provided information and documentation (or February 3, 2022, the date on which Navy provided such information) regarding the status of the cases that we identified from the four selected MTFs. 7GAO-14-704G. 8GAO-14-704G. Page 31 GAO-22-104668 Military Health Care Appendix I: Objectives, Scope, and Methodology that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. Page 32 GAO-22-104668 Military Health Care Appendix II: Comments from the Department Appendix II: Comments from the Department of Defense of Defense Page 33 GAO-22-104668 Military Health Care Appendix II: Comments from the Department of Defense Page 34 GAO-22-104668 Military Health Care Appendix II: Comments from the Department of Defense Page 35 GAO-22-104668 Military Health Care Appendix III: GAO Contact and Staff Appendix III: GAO Contact and Staff Acknowledgements Acknowledgements Sharon M. Silas at (202) 512-7114 or silass@gao.gov GAO Contact In addition to the contact named above, Ann Tynan (Assistant Director), Staff Kaitlin M. McConnell (Analyst-in-Charge), Bianca Eugene, Jeanne Acknowledgements Murphy-Stone, and Zoe Ziliak Michel made key contributions to this report. Also contributing were Jennie F. Apter, Jacquelyn Hamilton, Alice Lin, and Vikki Porter. 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