VA Health Care: Additional Training Could Improve Organ Transplant Referral and Evaluation Processes

As of June 2019, over 113,000 people in the United States—including veterans—were waiting for an organ transplant. In 2018, more than 36,000 organ transplants were performed at transplant centers across the country, including those within the Department of Veterans Affairs' (VA) Organ Transplant Program.

GAO was asked to review how VA administers and oversees its organ transplant program. This report, among other things, examines the process and timeliness with which VA reviews referrals and completes evaluations for organ transplants.

GAO reviewed data from VHA's Transplant Referral and Cost Evaluation Reimbursement database, documents related to VA's transplant program, and federal internal control standards. GAO conducted site visits to three of the 12 VATCs, selected to obtain diversity in geography and types of organs transplanted. At the selected VATCs, GAO reviewed facility data and documents related to organ transplants and interviewed officials. GAO also collected and reviewed information from the remaining nine VATCs.

The 12 Veterans Affairs' transplant centers (VATC), which are overseen by the Veterans Health Administration (VHA), almost always met the referral timeliness standard from fiscal years 2014 through 2018. When a veteran is determined to be a potential candidate for an organ transplant, he or she can receive a formal referral to a VATC. Depending on the type of referral, the VATC must meet specific timeliness standards for reviewing the referral and deciding if the veteran should receive a full evaluation. Likewise, VATCs have timeliness standards for conducting the full evaluation, and generally showed improvement in meeting that standard from fiscal years 2014 through 2018. For those delays in conducting full evaluations that did occur, GAO found they varied by organ type and VATC. Specifically, in fiscal year 2018, transplant evaluation timeliness ranged from 60 percent at two VATC kidney programs to 100 percent at kidney, liver, heart or lung programs across seven different VATCs.

According to VATC officials, transplant evaluation delays are caused when patients or caregivers are not available or not aware that they are required to be evaluated within 30 days of being referred. Although veterans may prefer to be seen at a later date, untimely evaluations can delay veterans' placement on the national organ donation waitlist. According to VHA data, 192 of the 1,617 transplant evaluation appointments completed in fiscal year 2018 did not meet the 30-day requirement. VATC officials said this was because veterans were not available or not aware of the requirement. GAO found that staff at referring VHA medical centers lacked a full understanding of the transplant referral and evaluation process. For example, VATC providers told GAO that transplant referrals are sometimes incomplete, requiring providers to spend extra time searching for information that should have been readily available. GAO found that additional training for medical center staff would help to improve the efficiency of the transplant referral process and the timeliness of transplant evaluations provided to veterans, a critical factor affecting veteran outcomes.

VHA should provide additional training for staff at VHA medical centers that refer patients for organ transplants on (1) submitting complete referrals and (2) understanding and communicating the veteran's role related to timely completion of transplant evaluations.

VA concurred in principle with the recommendation and described actions the department will take to address the recommendation.

Organ transplantation is a life-saving procedure for many Americans and  is the leading form of treatment for patients with severe organ failure. In  2018, individuals at transplant centers across the United States received  36,527 transplanted organs, including veterans receiving treatment  through the Department of Veterans Affairs (VA). However, as of June  2019, over 113,000 individuals remained on the waiting list to receive an  organ and an average of more than 20 people died each day waiting for  an organ.

To serve veterans in need of an organ transplant, VA established the VA  Organ Transplant Program in 1961. VA’s Veterans Health Administration  (VHA) administers the program, through which VHA refers, evaluates,  and provides solid organ transplant services to veterans through a  network of 12 VA transplant centers (VATC). More broadly, the Health  Resources and Services Administration, within the Department of Health  and Human Services, oversees the Organ Procurement and Transplantation Network (OPTN), which develops national policies for  organ allocation, maintains the waiting list of individuals seeking organ  transplants, and tracks data on individuals awaiting and receiving donated  organs in the United States, including veterans in the VA Organ  Transplant Program.

Media reports have raised concerns about barriers to care for veterans  needing an organ transplant; specifically, providing veterans with  reasonable access to transplant care. To address some of these  concerns, in June 2018, the VA MISSION Act of 2018 was enacted and  expands the agency’s ability to authorize community care for covered  veterans requiring an organ transplant and who have a medically  compelling reason to travel outside of the region in which they reside to  receive the transplant.

You asked us to provide an overview of the VA Organ Transplant  Program, including VHA’s management and oversight of the program.  This report  1.  describes how VHA provides organ transplants for veterans;  2.  provides information on the volume, outcomes, and associated  spending for organ transplants VHA provided from fiscal years 2014  through 2018; and  3.  examines the process and timeliness with which VHA provided  referrals and evaluations for organ transplants from fiscal years 2014  through 2018.

To describe how VA provides organ transplants for veterans, we reviewed  relevant VA and VHA policies and procedures, and prior GAO reports.  The VHA policies included the VHA directive that contains guidance on  how the program operates, and VHA tools and criteria for managing  transplant care. To obtain the perspectives of those overseeing and  operating within the VA Organ Transplant Program, we interviewed  officials from VHA’s National Surgery Office, which oversees the organ  transplant program, and gathered information from all 12 of the VATCs  that provide solid organ transplants. We conducted site visits to three  VATCs—located in Madison, Wisconsin; Nashville, Tennessee; and  Richmond, Virginia—to understand the overall transplant process; how  the program is administered, overseen, and assessed; how and where  transplant care is provided; and how lodging and transportation are  provided to veterans. To collect similar information from the nine VATCs  we did not visit, we used a structured question set to gather written  responses and documentation. Finally, we interviewed officials from the  Health Resources and Services Administration and the United Network  for Organ Sharing to understand their roles in the national organ  allocation and transplant systems.

To provide information on the volume, outcomes, and associated  spending for organ transplants provided by VHA from fiscal years 2014  through 2018, we collected and analyzed related VHA and publicly  reported data. Specifically, we reviewed documentation assessing the  quality of contracted transplant services from all VATCs that have  contracts with academic affiliates. We also analyzed mortality data from  VHA’s Transplant Referral and Cost Evaluation/Reimbursement  (TRACER) database for veterans who obtained a transplant from fiscal  years 2014 through 2018 and publicly reported data from the Scientific  Registry of Transplant Recipients to determine health outcomes and  transplant survival rates for the general population, including veterans  who received transplants during this time period. We assessed the  reliability of the data by reviewing relevant documentation, interviewing  knowledgeable United Network for Organ Sharing officials, and reviewing  the data for missing values. We concluded that the data were sufficiently  reliable for analyzing survival rates for the general population, but were  not sufficiently reliable for identifying veterans who received transplants  through VHA. As a result, we could not compare health outcomes,  including survival rates, between veterans in the database and the  general population. We also interviewed officials from VHA’s National  Surgery Office and Office of Finance. In addition, we interviewed VATC  staff at our site visit locations to gather information and perspectives on  the outcomes of solid organ transplants, and the contracts for transplant  services with academic affiliates.

To examine the process and timeliness with which VATCs provided  referrals and evaluations for veterans seeking organ transplants from  fiscal years 2014 through 2018, we reviewed policies outlining VA’s  process for preparing and reviewing transplant referrals and timeliness  standards related to transplant referrals and evaluations. We also  analyzed data from the TRACER database on organ transplant patient  referrals, evaluations, and transplants for fiscal years 2014 through  2018. To assess the timeliness of VATC referral reviews, we calculated  the number of business days or the number of hours—between the  referral submission date/time and the decision date/time—and compared  them to the timeliness standards. To assess the timeliness of VATC  evaluations, we calculated the number of calendar days between the  referral submission date and the evaluation date and compared them to  the timeliness standards. We assessed the reliability of the data by  reviewing relevant documentation, interviewing knowledgeable VHA  officials, and reviewing the data for missing values and outliers. We  determined that these data were sufficiently reliable for the purposes of  our audit objectives. Additionally, we interviewed VHA officials from the  National Surgery Office and from VATCs where we conducted site visits,  as well as those located in Birmingham, Alabama; Pittsburgh,  Pennsylvania; and Houston, Texas, about reasons for delays in referral  reviews and evaluations. Further, we interviewed officials from five VHA  medical centers that refer veterans for transplant services to hear their  perspectives on the training and education provided on the referral  process. We evaluated VHA’s process for sharing information with VHA  medical center transplant coordinators on submitting referrals and  scheduling evaluations for transplant candidates against federal internal  control standards.

We conducted this performance audit from April 2018 to October 2019 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 the  evidence obtained provides a reasonable basis for our findings and  conclusions on our audit objectives.

VA administers one of the largest health care systems in the United  States and is charged, through the VHA, with providing health care  services to the nation’s eligible veterans. VHA expects to provide care to  more than 7 million veterans in fiscal year 2019 at health care facilities  across the country through a system of 18 regional networks known as  Veterans Integrated Service Networks. VHA has 172 medical centers  that offer a variety of inpatient and outpatient services, ranging from  routine examinations to complex surgical procedures. VHA’s health care  system also includes community-based outpatient clinics and other  facilities that generally limit services to primary care and some specialty  care. When veterans need services that are not available at VHA medical  facilities or within required driving distances or time frames, VHA may  purchase care from non-VHA providers through one of its community care  programs.

VHA’s National Surgery Office is charged with overseeing the VA Organ  Transplant Program, including the 12 VATCs that have established  specialty services to provide solid organ transplant surgery and post- operative care, in some cases in conjunction with an academic affiliate.  VATCs offer transplants for one or more organ types including heart,  kidney, liver, and lung. (See fig. 1.)

VHA considers transplant services provided through a VATC’s academic  affiliate as care provided within the VA Organ Transplant Program. VHA’s  National Surgery Office is responsible for clinical and operational  oversight, as well as policies related to the VA Organ Transplant  Program, including  facilitating and monitoring the transplant referral process; overseeing quality of care; and monitoring outcomes of veterans receiving transplants.

In 2013, VHA’s National Surgery Office established TRACER to track and  monitor the referrals, evaluations, and outcomes for organ transplants  performed at the VATCs. Referring VHA medical centers use the  database to enter a referral for a veteran to be evaluated at a VATC; and  VATCs use it to record referral reviews, patient evaluations, transplant  outcomes, and follow-up care. In addition, the database provides the  National Surgery Office with information used to monitor transplant  volumes, the referral and evaluation process, and clinical outcomes  across all VATCs. The VA Organ Transplant Program’s services include  pre-transplant evaluation and testing, transplant surgery, post-transplant  follow-up care, as well as transplant-related round-trip travel and lodging  for both the veteran and a caregiver. VHA covers the cost of lodging for  the veteran and caregiver through a variety of arrangements including  contracts with local hotels and on-site VHA medical center housing, such  as through the Fisher House Program. In addition, VHA may cover the  cost of transplant services provided by non-VA providers; for example,  when a veteran in urgent need of a heart transplant cannot travel to a  VATC that provides that service.

The VA MISSION Act includes provisions regarding VA’s authority to  cover organ transplant services by non-VA providers—referred to as  community care. Prior to the VA MISSION Act, VHA used its authority,  as needed, to contract for transplant services with providers in the  community when VHA care and services were not accessible in a timely  fashion; however, the act provides additional authority to improve  veterans’ access to transplant care and services through community  providers, and authorizes transplant procedures with living organ donors  who are not eligible for VHA care. On June 5, 2019, VA issued final  regulations for the act.

Oversight and Process for Organ Allocation in the United States

The Health Resources and Services Administration contracts with the  United Network for Organ Sharing—a private, nonprofit organization—to  manage the OPTN, which creates and maintains transplant policies and  bylaws that are applicable to all transplant centers in the United States,  including the VATCs and the academic affiliates performing transplants  under contract with them. OPTN documents organ allocation policies, and  collects and reports data on transplant recipients, donors, and outcomes.  OPTN also conducts periodic audits of transplant program performance,  including ensuring that transplant programs meet functional activity  requirements (i.e., performing a minimum number of transplants in a  proscribed period of time), and reviewing post-transplant patient survival  rates. In addition, OPTN assesses whether transplant centers have  established required quality assurance and performance improvement  programs to help ensure the quality and safety of the transplant services  provided.

When transplant centers, including the VATCs, identify a candidate for  organ transplantation, they register the patient in the OPTN’s centralized,  national computer network that matches organ donors with transplant  candidates, referred to in this report as the “national organ donation  waitlist.” Veterans do not receive preference for organ allocation. When  an organ becomes available, the computer network generates a list of  transplant candidates ranked by a standard set of criteria that generally  include factors such as blood and tissue type,  size of the organ, medical urgency of the candidate,  time on the waitlist, and geographic distance between the organ donor and transplant  candidate.

An organ procurement specialist then contacts the transplant program of  the top-ranked transplant candidate to determine if the available organ is  suitable for the candidate. If the organ is suitable, arrangements are  made to procure, transport, and store the donated organ, and for the  transplant candidate to travel to the transplant center for surgery. If the  organ is not suitable for a given candidate, the procurement specialist  contacts the transplant program of the next transplant candidate on the  list until the organ is found to be suitable for a transplant candidate.

Each year, VA allocates most of its appropriations for health care services  to VHA’s 18 Veterans Integrated Service Networks through the Veterans  Equitable Resource Allocation (VERA) system. VERA funds are allocated  for general purposes, such as treatment for basic and complex patients,  research and educational support, and equipment and maintenance  costs; as well as for specific purposes, such as preventative and primary  care initiatives and transplant care. The VERA model uses price groups— categories of veterans with similar resource needs based on the  complexity of their medical conditions—to determine the funding level for  each network. In addition, VHA’s National Surgery Office historically  allocated transplant specific purpose funds to the VATCs for solid organ  transplants, because the costs of transplant services were not fully  covered by general purpose funds. Beginning in fiscal year 2019, the  VERA model was modified to establish a new price group specifically for  transplant patients, allowing full funding with general purpose funds for  these services. VHA officials explained that this change is expected to  reduce the need for specific purpose funds to supplement transplant care.  VHA officials told us academic affiliate contracts are funded through the  medical services appropriations allocated to the VHA medical center  where the VATC is located.

VHA Provides Organ Transplants to Veterans through a Multi-Step Process

To receive an organ transplant in the VA Organ Transplant Program, a  veteran must go through a five-step process: (1) initial referral, (2) pre- operative evaluation, (3) listing on the OPTN national organ donation  waitlist, (4) transplant surgery, and (5) follow-up care that continues for  the remainder of the veteran’s life. See figure 2 for an overview of the five  steps.

Step 1: Initial screening and referral. A veteran seeking an organ  transplant begins the process by having an initial screening at a referring  VHA medical center. If VHA medical center providers determine that the  veteran is a potential candidate for an organ transplant, they may prepare  a formal referral to a VATC. To prepare a referral, the providers use an  organ-specific checklist and other tools developed by VHA’s National  Surgery Office with input from other experts in the field to perform a  standard set of assessments of the veteran’s clinical, social, and mental  health status. In addition, VHA officials told us that the initial screening  includes an assessment of the veteran’s social and family support; for  example, identifying a caregiver who can accompany and stay with the  veteran throughout the transplant process. In addition, there are organ- specific criteria, such as negative tobacco smoking screens for veterans  seeking a heart transplant, and up-to-date dialysis information for liver  and kidney transplant candidates. VHA officials noted that the providers  may consult with staff at a VATC as needed during the initial screening  phase.

Following the initial screening, if VHA medical center providers determine  that the veteran is a potential candidate for a transplant, they enter the  checklist information into the TRACER database, include the results of  the required assessments outlined in the checklist, and attach any  additional medical information, such as testing performed through care in  the community. VHA officials told us that the VATC to which the veteran  is referred is chosen based on factors including distance from the  veteran’s home and the types of organ transplants offered at the VATC.  Once the VHA medical center completes a referral in TRACER, the  information becomes available to the selected VATC.

Step 2: VATC referral review and veteran evaluation. When the VATC  receives a veteran’s referral, VATC staff review it to determine whether  the referral information is complete and the veteran meets the criteria to  continue the process. If so, VATC staff evaluate the veteran and perform  additional testing and clinical preparation needed to determine whether  the veteran is a transplant candidate. To reduce the travel burden on  veterans and their caregivers, providers at the veteran’s referring VHA  medical center may arrange for telehealth visits with the VATC for pre- transplant education and consultation. However, travel for in-person  appointments at the VATC is required for most veterans referred for  evaluation.

According to VATC officials we spoke with, the VATC considers the  severity of the veteran’s illness and overall need for a transplant. In some  cases, this assessment is conducted by a panel of experts composed of  VATC providers and providers from the academic affiliate, where  applicable. For example, some VATCs hold regular review meetings to  discuss cases up for consideration jointly with providers from the VHA  medical center and the academic affiliate, because individual cases may  be co-managed depending on the type of organ being transplanted and  the services provided at an individual VATC. Providers at some VATCs  provide care at both the VATC and its academic affiliate, allowing for  integrated clinical management of patients.

If the VATC determines the veteran is not a candidate for transplantation,  the referring VHA medical center can request a second opinion by  another VATC. If the veteran is once again determined not to be a  candidate, the referring VHA medical center can make a final appeal.  Appeals are forwarded to the VA’s Transplant Surgical Advisory Board,  comprised of subject matter experts, for consideration. According to VHA  policy, the board considers the appeal and makes a recommendation to  the National Director of Surgery (the head of VHA’s National Surgery  Office) who is responsible for facilitating second opinion requests, making  the final determination, and notifying the referring VHA medical center  regarding the final appeal determination. VHA reported that between  fiscal years 2014 and 2018, 39 decisions were appealed to the Transplant  Surgical Advisory Board, one of which was approved for resubmission to  another VATC for consideration.

Step 3: Listing on the national organ donation waitlist. If the VATC  determines that the veteran is a candidate for an organ transplant, VATC  staff add the veteran to the national organ donation waitlist. At this point  in the process, veterans follow the same procedure as the general  population seeking an organ transplant. To maximize the chances that  the veteran will receive an organ, the VATC staff may also discuss options the veteran can pursue for personally identifying a potential living  donor (if applicable for the organ needed). VATC officials noted that  they may provide other clinical interventions to help prolong a veteran’s  life and preserve his or her health while awaiting an organ; for example,  implanting a ventricular assist device into a veteran awaiting a heart  transplant.

Step 4: Transplant surgery. According to VATC officials, once a veteran  is placed on the OPTN national organ donation waitlist, depending on the  type of organ needed, the veteran and their caregiver may be required to  travel to the VATC and remain in close proximity while awaiting organ  availability. In some cases, such as for a liver transplant, a harvested  organ can be kept viable for longer periods, allowing time for a veteran to  travel from their home to the VATC once the organ becomes available.  Depending on the arrangement between a particular VATC and its  academic affiliate, the veteran could receive the transplant surgery and  post-operative care at either the VATC or the affiliate. For example, the  VATC in Richmond performs heart transplants and contracts with its  affiliate for liver transplants. The VATC in Nashville performs kidney  transplants and contracts with its affiliate for heart and liver transplants.  From fiscal years 2014 through 2018, 61 percent of the transplant  surgeries provided within the VA Organ Transplant Program were  performed by a VATC and 39 percent were performed by an academic  affiliate. See table 1 for a list of VATCs, organ types transplanted, and  contracts with academic affiliates.

Step 5: Follow-up care. Following the transplant surgery and the  immediate post-operative care provided by the VATC and its academic  affiliate, the veteran receives on-going follow-up care from both the VATC  and the referring VHA medical center. VHA providers monitor veterans  post-transplant for the remainder of their lives; for example, to oversee  post-transplant immunosuppression, and track survival rates and  outcomes for organ recipients. VA policy states that the VATC has  primary responsibility for providing care while the veteran is at the VATC  for the transplant and for providing specialized follow-up care after the  veteran is discharged. In general, however, following discharge from the  VATC, the veteran’s referring VHA medical center maintains responsibility  for the veteran’s care coordination.

VHA has policies and processes to allow for some aspects of transplant- related care, including follow-up care, to be done via telehealth—that is,  visits with a VATC provider remotely from the veteran’s referring VHA  medical center. VHA medical centers may establish telehealth  agreements with VATCs to ease the burden of travel for veterans and  their caregivers, and to allow for ongoing monitoring of the veteran’s  health post-transplant. Because VHA monitors transplant recipients for  the rest of their lives, using telehealth can decrease the need for the  veteran to travel back to the VATC unless a specific clinical need arises,  such as biopsies for heart transplant recipients. VHA officials noted that  follow-up care is facilitated by VA’s shared electronic health record, which  allows VHA providers to share medical records and other patient  information over time and across locations. Further, VHA providers noted  that follow-up care and communication between VATCs and primary care  teams can be more complicated in the private sector when transplant  services are not generally part of a patient’s whole system of care.

The Number of VHA Organ Transplants and Related Allocations and Spending Generally Increased from Fiscal Years 2014 through 2018

The Number of Organ Transplants at VATCs Increased between Fiscal Year 2014 and Fiscal Year 2018

VATCs provided about 1,700 organ transplants between fiscal year 2014  and fiscal year 2018. The number of organ transplants provided each  year generally increased, ranging from 300 transplants in fiscal year 2014  to a peak of 400 transplants in fiscal year 2017. During this 5-year period,  kidneys and livers were the most frequently transplanted organs,  representing 85 percent of all organs transplanted at VATCs. Heart and  lung transplants were much less common and represented the remaining  transplants. (See fig. 3.)

For the programs that were active during all 5 years from fiscal year 2014  through fiscal year 2018, the number of solid organ transplants performed  varied by VATC, ranging from 12 at the Birmingham VATC to 399 at the  Pittsburgh VATC. (See table 2.)

The nearly 1,700 transplants performed through the VA Organ Transplant  Program represent a relatively small portion—less than 20 percent—of  the VHA referrals for organ transplant between fiscal years 2014 and  2018. While thousands of veterans are referred for solid organ  transplants, far fewer veterans ultimately receive transplants. According  to VA officials, VHA considers all submitted transplant referrals; however,  many patients do not meet initial screening criteria to proceed with a  formal evaluation. For example, a veteran’s state of illness may not be  severe enough to warrant a full transplant evaluation. Further, some  veterans who are offered transplant evaluations decide not to proceed  following education about the process. Officials noted that in many cases,  the transplant evaluation reveals that a veteran does not meet the criteria  for a transplant, such as not having a committed caregiver who can  support the veteran through the evaluation and transplant procedure. Of  the veterans who are listed on the national organ donation waitlist, VHA  officials report that the number of transplants is limited by the supply of  organs, which does not meet the demand in the U.S. general population,  including veterans.

For veterans who received an organ transplant from a VATC between  fiscal year 2014 and fiscal year 2018, survival rates varied by organ type,  with the 3-year survival rate ranging from about 95 percent for kidney  transplants to 85 percent for lung transplants, according to National  Surgery Office data. (See table 3.) For national-level general population  survival rates, see appendix II.

VHA Allocations and Spending for Organ Transplants Increased from Fiscal Year 2014 through Fiscal Year 2018

Consistent with the increase in the number of organ transplants provided  between fiscal years 2014 and 2018, VHA’s allocations and spending for  transplant services also increased, similarly peaking in fiscal year 2017.  VHA funds these services using a combination of general purpose and  specific purpose funds. VHA’s National Surgery Office allocates  transplant specific purpose funding to the VATCs based upon the  transplant-related workload the VATCs report through TRACER. See  appendix III for additional information on transplant-related allocations  and expenditures.

VHA Allocation of Transplant Specific Purpose Funds. VHA  allocated $292 million in transplant specific purpose funds during this  5-year period, ranging from $50.3 million in fiscal year 2014 to  approximately $64.6 million in fiscal year 2018. (See table 5 in app.  III.) Transplant specific purpose funds are used to support program  overhead costs (infrastructure and maintenance) associated with  organ transplants performed at VATCs. In addition, they are used for  pre-transplant evaluations, lodging, and some miscellaneous costs  associated with transplants, such as living donor evaluations. Further,  transplant specific purpose funds are used to fund other VHA medical  centers without a VATC that perform certain transplant follow-up  care.

VHA Expenditures for Transplant-Related Services

VHA Expenditures of General Purpose and Specific Purpose  Funds for Veterans Receiving a Solid Organ Transplant. VHA  spent approximately $259 million for services provided to veterans  who received a solid organ transplant at a VATC during this 5- year period, ranging from $44.6 million in fiscal year 2014 to a  high of $57.7 million in fiscal year 2017. Similarly, VHA’s  spending for pre- and post-transplant care provided at VHA  medical centers totaled approximately $68.6 million during this  time, ranging from $10.8 million in fiscal year 2014 to $15.6 million  in fiscal year 2017. (See tables 6 and 7 in app. III.)

VHA Contracts with VATC Academic Affiliates. VHA spent over  $216 million on contract payments to academic affiliates for  transplant services during this period, ranging from $34.9 million in  fiscal year 2014 to a high of $49.9 million in fiscal year 2017. This  increased spending corresponded to an increase in the number of  transplants performed by academic affiliates, which totaled 669  transplants—nearly 40 percent of all VATC transplants from fiscal  year 2014 through fiscal year 2018. The highest volume—146  transplants—and the highest cost—$49.9 million—occurred in  fiscal year 2017. (See table 8 in app. III.)

VHA Contracts for Community Care. From fiscal year 2014  through fiscal year 2018, VHA spent $7.9 million for solid organ  transplant services provided to 53 veterans through community  care programs. (See table 9 in app. III.) According to VHA data,  over this 5-year period, 50 of these transplants were authorized  using title 38 U.S.C. § 1703 (“Non-VA Medical Care Program”).  The remaining three were funded using the Veterans Access,  Choice, and Accountability Act of 2014 (Choice Act)—totaling  approximately $411,000 of the $7.9 million. VA has reported that  while the Choice Act allows VHA to provide an eligible veteran  transplant care at a transplant center in the community, generally  at Medicare rates, organ procurement is only partially covered at  Medicare rates. This has resulted in community providers being  less willing to provide transplant services for VHA patients through  community care programs.

Timeliness of VHA’s Transplant Referrals and Evaluations Improved from Fiscal Years 2014 through 2018, but Inefficiencies in VA Processes Exist

Timeliness of Referral Reviews Improved from Fiscal Years 2014 through 2018, but Opportunities for Increased Efficiencies Exist

From fiscal years 2014 through 2018, VATCs received 10,494 referrals  from VHA medical centers. In that time, the percentage of VATC referrals  that met timeliness standards outlined by VHA’s National Surgery Office  improved.

Stable condition referrals: For veterans in stable condition, VHA  requires that VATCs review referrals and decide within 5 business  days whether veterans are potential candidates for an organ  transplant and should receive a full evaluation. The percentage of  referrals for which VATCs met the timeliness standard increased from  95 percent in fiscal year 2014 to 99 percent in fiscal year 2018.

Emergency condition referrals: For veterans in emergency  circumstances, VHA requires that VATCs review referrals and  document within 48 hours whether veterans are potential transplant  candidates and should receive a full evaluation. The percentage of  referrals for which VATCs met the timeliness standard increased from  94 percent in fiscal year 2014 to 98 percent in fiscal year 2018. (For  more information, see app. IV.)

National Surgery Office officials identified two possible drivers of the  observed improvements: (1) increased monitoring, and (2) providing real- time feedback to VATCs through TRACER. Providers at one VATC  noted that they use information from the National Surgery Office’s  Transplant Quarterly Reports to identify areas to improve and they  assigned a transplant team nurse the responsibility to monitor program  quality, including that timeliness requirements are being met. A provider  at a VATC where timeliness has improved since fiscal year 2014 and is  now at 100 percent explained that his facility has provided training to staff  at referring VHA medical centers they work with frequently. For example,  the official said he has hosted a workshop for transplant coordinators to  provide training on submitting transplant referral packets through  TRACER.

While VATCs almost always met timeliness standards in fiscal year 2018,  VATC officials in our review noted that transplant coordinators at referring  VHA medical centers sometimes submit referral packets that are  incomplete, requiring additional time and effort by the provider to search  for information not readily available and potentially adding delays to the  VATC review times. VHA requires that a complete referral packet be  submitted through TRACER using a referral progress note that contains  the required assessments outlined in the organ-specific checklist. The  referral packet can also include attachments to transmit some required  information, such as results for tests performed by community providers.  Providers at three VATCs told us that reviewing a complete referral  packet generally takes 30 minutes to an hour. However, in cases where  the packet is incomplete (for example, it does not include the results from  all the required assessments) the process is much less efficient and,  according to two providers we interviewed, can take up to 5 hours. VATC  providers explained that when not all test results are available in the  referral packet, they have to access another VHA medical center’s  electronic medical record system and search for the required information.  Accessing another medical center’s system adds time to the referral  review process and can take time away from the provider’s other duties,  such as providing follow-up care to transplant patients or monitoring  transplant outcomes.

Internal controls state that management should assign responsibility to  discrete units and demonstrate a commitment to develop competent  individuals in those units, such as through training, to enable the  organization to operate in an efficient manner and help achieve the  organization’s objectives. However, a lack of understanding or  implementation of the required information needed in the referral packets  can make the process for reviewing the referral packets inefficient in  some cases. Specifically, one VATC provider told us that incomplete  referral packets are often due to a lack of training for staff at the referring  VHA medical centers on the process for submitting referrals through  TRACER. In fact, four of the five transplant coordinators at referring VA  medical centers we interviewed reported a lack of training on submitting  transplant referrals through TRACER. Instead, for example, a transplant  coordinator at one referring VHA medical center said she received  assistance from a medical clerk at her facility on how to submit referrals  through TRACER. Officials at VHA’s National Surgery Office told us that  although there is no centralized, in-person training available for referring  VHA medical centers, the office published a training guide, which is  available on VA’s intranet and provides guidance on how to access  TRACER and refer patients for transplant evaluation. Despite this  resource, transplant coordinators from some referring VHA medical  centers still cited a need for additional training or other guidance. For  example, one official said training for new transplant coordinators would  be helpful as would regular updates on transplant criteria or policy  changes, such as through regular calls or a newsletter targeted at  transplant coordinators.

Timeliness of Potential Transplant Candidate Evaluations Improved From Fiscal Years 2014 through 2018, but Some Delays Remain

In addition to timeliness requirements for referral review, VHA requires  that VATCs complete an evaluation of veterans within 30 calendar days  of receiving a referral to determine whether they are a candidate for  transplant and should be placed on the national organ donation waitlist.  From fiscal years 2014 through 2018, VATCs increased the percentage of  evaluations completed within this time frame, from 55 percent (576 of  1,045 appointments) in fiscal year 2014 to 89 percent (1,193 of 1,346  appointments) in fiscal year 2017, before dropping to 87 percent (1,325 of  1,521 appointments) in fiscal year 2018. National Surgery Office officials  attributed the overall improvement to increased monitoring and the  increased availability of telehealth for conducting transplant evaluations.  See appendix IV for more information on the timeliness of transplant  evaluations by VATCs from fiscal years 2014 through 2018.

The extent to which delayed evaluations occurred varied by VATC  location and by organ type each fiscal year. For example, in fiscal year  2018, we found that the average time from referral to completed  evaluation was less than 30 days for 19 of the 20 organ transplant  programs, and overall, 13 percent of evaluations were not completed  within 30 days. Of note, 51 of 128, or 40 percent, of evaluations for  kidney transplant at the Bronx VATC were completed more than 30 days  after the referral was submitted, with evaluations ranging from 5 to 84  days after submission. In contrast, all 69, or 100 percent, of liver  evaluations at the Nashville VATC were completed within 30 days, with  evaluations ranging from 0 to 28 days after the referral was submitted.  (See fig. 4.)

According to VHA data and three VATC providers we interviewed,  evaluation appointment availability is not a cause for delays in most  cases; rather, delays are primarily due to veteran preference. According  to VHA data for 1,617 evaluation appointments completed in fiscal year  2018, 1,412 appointments were scheduled within the 30-day requirement.  For the remaining 205 appointments, 13 were delayed due to lack of  appointment availability, and 192 appointments were delayed due to  veteran preference. According to providers at the three VATCs we  interviewed, while veterans may prefer to be seen at a later date for a  number of reasons, including that their caregiver is not available to travel,  veterans are not always aware that they should be evaluated within 30  days of being referred for a transplant. VHA requires the referring VHA  medical center to discuss the 30 day evaluation requirement with the  veteran prior to submitting the referral. According to VHA, in some cases  evaluation timeliness is a critical factor affecting patient outcomes.  Although a veteran may choose to be seen at a time beyond the 30-day  standard, postponing an evaluation may delay their placement on the  national organ donation waitlist, potentially having a negative impact on  their health and well-being.

Officials at five VATCs and two referring VHA medical centers reported  that additional training for transplant coordinators would be helpful for  improving evaluation timeliness. Additional training enables employees to  develop competencies and reinforce requirements, which is consistent  with internal control standards that state that management should  develop competent individuals to achieve the entity’s objectives.  According to one VATC provider, transplant coordinators at referring VHA  medical centers should be trained to discuss travel with the veteran  before submitting the referral, so the transplant coordinator and the  veteran understand that the evaluation should be completed within 30  days of referral, increasing the likelihood that veterans will be able to  schedule timely evaluations. A referring VHA medical center transplant  coordinator also said that additional training about the VATC’s processes  would be helpful in order to be better able to inform veterans and their  caregivers about what to expect from the transplant process.

Placing veterans on the national organ donation waitlist as soon as  possible is critical for potential transplant candidates to be matched with a  donor organ. Since fiscal year 2014, VHA has improved timeliness for  reviewing transplant referrals to determine if a veteran is a candidate and  for completing transplant evaluations. However, VHA medical center staff  do not always submit complete transplant referral packets through  TRACER, which can create inefficiencies and delay the referral review  process. Similarly, inefficiencies in the transplant evaluation process  occur when VATC and VHA medical center staff do not fully inform  veterans of their role in the transplant evaluation process, specifically,  that their evaluation be completed within 30 days of referral. Without  additional training to address these inefficiencies a veteran’s placement  on the national organ donation waitlist could be delayed.

The Under Secretary for Health should establish a requirement that  VHA’s National Surgery Office provide additional training to staff at  referring VHA medical centers on (a) submitting referral packets through  TRACER that are complete, and (b) understanding and communicating  the veteran’s role in the evaluation process related to the timely  completion of transplant evaluations. (Recommendation 1)

We provided a draft of this product to VA for comment.  In its comments,  reproduced in appendix V, the department concurred in principle with our  recommendation, reiterated the resources it currently makes available to  staff at referring VHA medical centers, and described actions it plans to  take to address the recommendation. Specifically, VHA’s National  Surgery Office plans to distribute a memorandum to all VHA facilities to  reinforce the available training and resources to support the staff at  referring VHA medical centers with submitting complete referrals, and to  ensure adequate communication of the veteran’s role in timely completion  of transplant evaluations. VA also provided technical comments, which  we incorporated as appropriate. In addition, we provided a draft of this  report to the Department of Health and Human Services for review and  they did not have any comments.

We are sending copies of this report to the appropriate congressional  committees, the Secretary of VA, the Secretary of the Department of  Health and Human Services, and other interested parties. In addition, the  report is 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 Office of  Congressional Relations and Office of Public Affairs can be found on the  last page of this report. Other major contributors to this report are listed in  appendix VI.

Appendix I: Department of Veterans Affairs Transplant Centers Providing Solid Organ Transplants (printable)

Appendix I: Department of Veterans Affairs  Transplant Centers Providing Solid Organ  Transplants (printable)

Appendix II: National Transplant Survival Rates by Organ Type for Fiscal Years 2014 through 2018

We analyzed national transplant survival rates by organ type using data  from the Scientific Registry of Transplant Recipients. All transplant  facilities across the United States, including Department of Veterans  Affairs transplant centers, provide data to this database. Table 4 shows  the national transplant survival rates by organ for fiscal years 2014  through 2018.

Appendix III: VA Resource Allocation and Veterans Health Administration Spending for Solid Organ Transplant Services

Annually, the Department of Veterans Affairs (VA) allocates most of its  appropriations for health care services to the Veterans Integrated Service  Networks within the Veterans Health Administration (VHA) through a  model called the Veterans Equitable Resource Allocation (VERA). The  VERA model is designed to fund patient care based on a methodology  that develops set, or “capitated,” rates for different groups or categories of  veterans with similar resource needs based on the complexity of their  medical conditions. Categories include oncology, visual impairment,  chronic mental illness, and critical illness. VERA uses a national formula  that considers the number of veterans and the complexity of care  provided; and certain geographic factors, such as local labor costs, in  determining how much each Veterans Integrated Service Network should  receive. VERA determines this amount based on each network’s activities  and needs in the following areas: patient care, equipment, nonrecurring  maintenance, education support, and research support. The networks, in  turn, allocate resources to their respective VHA medical centers, including  those with VA transplant centers (VATC). The networks distribute VERA  funds to VHA medical centers based on the complexity of patients treated  at the medical center in previous fiscal years.

This appendix provides VA’s reported allocations and expenditures for  solid organ transplant services through its VATCs and contracts with  academic affiliates and community providers from fiscal year 2014  through fiscal year 2018.

Table 5 shows VHA allocation of transplant specific purpose funds by  VATC for transplant-related services.

Table 6 shows VHA expenditures at each VATC for veterans who  received solid organ transplants.

Table 7 shows VHA expenditures for pre- and post-transplant services  provided by VHA medical centers without a VATC for veterans who  received transplants.

Table 8 shows the total number of transplants and contract payments  to academic affiliates for solid organ transplant services.

Table 9 shows total number and spending for solid organ transplants  provided by community care providers.

Appendix IV: Timeliness of Veterans Health Administration Transplant Referrals and Evaluations

The Veterans Health Administration (VHA) has timeliness requirements  for reviewing transplant referrals to determine whether veterans are  potential candidates for organ transplant and should receive a full  evaluation, and for completing timely evaluations for potential candidates.

Timeliness of referral reviews improved from fiscal year 2014 through  fiscal year 2018. VHA requires that for veterans in stable condition,  Department of Veterans Affairs transplant centers (VATC) review referrals  and decide within 5 business days whether veterans are potential  candidates for an organ transplant and should receive a full evaluation.  For emergency cases, VATCs should perform this review and document  the results within 48 hours. Table 10 shows the number of referrals  reviewed and the percentage of timely referrals for each VATC and organ  transplant program from fiscal year 2014 through fiscal year 2018.

VHA requires that VATCs complete an evaluation of stable veterans  within 30 calendar days of receiving a referral to determine whether they  are a candidate for transplant and should be placed on the national organ  donation waitlist. The percentage of evaluations completed within the  required time frame increased from 55 percent in fiscal year 2014 to 87  percent in fiscal year 2018, although some variation can be seen by  organ type and location within each fiscal year. Table 11 shows the  number of completed evaluations and the percentage of timely  evaluations for each VATC and organ transplant program from fiscal year  2014 through fiscal year 2018.

Appendix V: Comments from the Department of Veterans Affairs

Appendix VI: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Marcia A. Mann (Assistant  Director), Jill K. Center (Analyst-in-Charge), Colin Ashwood, Emily Binek,  Emily Bippus, Shana Deitch, Keith Haddock, and Ebony Russ made key  contributions to this report. Also contributing were Krister Friday,  Jacquelyn Hamilton, Giselle Hicks, Drew Long, Vikki Porter, and Ethiene  Salgado-Rodriguez.

If a veteran needs a transplant (such as a kidney), the Department of Veterans Affairs has 12 solid organ transplant centers around the country. Veterans are initially screened at a VA medical center, which can refer them to a transplant center.

The transplant center typically has 30 days to evaluate and decide whether the veteran continues the process—the next step being placement on the national organ waitlist.

VA almost always met its referral timeliness standard and generally improved the speed of evaluations from 2014 through 2018. We recommended that VA provide additional training to speed transplant referrals and evaluations.


Critical Infrastructure Protection: Progress and Challenges in DHS's Management of Its Chemical Facility Security Program

Thousands of facilities across the United States contain hazardous chemicals that could be used by terrorists to inflict mass casualties or harm surrounding populations. In accordance with the DHS Appropriations Act, 2007, DHS established the CFATS program to, among other things, identify and assess the security risk posed by chemical facilities. DHS inspects high-risk facilities after it approves facility security plans to ensure that the facilities are implementing required security measures and procedures.

This statement summarizes progress and challenges related to DHS's CFATS program management. This statement is based on prior products GAO issued from July 2012 through August 2018, along with updates as of September 2018 on actions DHS has taken to address GAO's prior recommendations. To conduct the prior work, GAO reviewed relevant laws, regulations, and DHS policies for administering the CFATS program; how DHS assesses risk; and data on high-risk chemical facilities. GAO also interviewed DHS officials and relevant stakeholders.

The Department of Homeland Security (DHS) has made progress addressing challenges that GAO's past work identified to managing the Chemical Facility Anti-Terrorism Standards (CFATS) program. The following summarizes progress made and challenges remaining in key aspects of the program.

Identifying high-risk chemical facilities. In July 2015, GAO reported that DHS used self-reported and unverified data to determine the risk of facilities holding toxic chemicals that could threaten surrounding communities if released. GAO recommended that DHS should better verify the accuracy of facility-reported data. DHS implemented this recommendation by revising its methodology so it now calculates the risk of toxic release, rather than relying on facilities to do so.

Assessing risk and prioritizing facilities. In April 2013, GAO reported weaknesses in multiple aspects of DHS's risk assessment and prioritization approach. To improve this process, GAO recommended that DHS enhance its risk assessment approach to incorporate all elements of risk and conduct a peer review after doing so. DHS implemented both recommendations by revising the CFATS risk assessment methodology to include threat, vulnerability, and consequence to better cover the range of security issues, and conducting peer reviews and technical reviews to verify and validate the CFATS program's new risk assessment approach.

Reviewing and approving facility site security plans . DHS is to review facility security plans to ensure their security measures meet DHS standards. In April 2013, GAO reported a 7- to 9-year backlog for these reviews. In July 2015, GAO reported that DHS had made substantial progress in addressing the backlog—estimating that it could take between 9 and 12 months for DHS to review and approve security plans for the approximately 900 remaining facilities. DHS has since taken additional action to expedite these activities and has eliminated this backlog.

Inspecting facilities and ensuring compliance. In July 2015, GAO found that nearly half of the facilities DHS had inspected were not fully compliant with their approved security plans and that DHS did not have documented procedures for managing facilities' compliance. GAO recommended that DHS document procedures for managing compliance. DHS revised CFATS procedures that, as of February 2019, GAO is reviewing to determine if they sufficiently address the recommendation.

Conducting stakeholder and first responder outreach. In August 2018, GAO reported that DHS shares some CFATS information with first responders and emergency planners but these stakeholders may not have all of the information they need to minimize the risk of injury or death when responding to incidents at high-risk facilities. GAO recommended that DHS should, among other things, take actions to explore opportunities to improve information-sharing with first responders and emergency planners. DHS concurred with this recommendation and reported in September 2018 that it is conducting additional outreach and taking other actions to implement it.

GAO has made various recommendations to strengthen DHS's management of the CFATS program, with which DHS has generally agreed. DHS has implemented or described planned actions to address these recommendations.

Thank you for the opportunity to discuss our past work on the Department  of Homeland Security’s (DHS) efforts to manage its Chemical Facility  Anti-Terrorism Standards (CFATS) program. Thousands of facilities that  produce, use, or store hazardous chemicals could be of particular interest  to terrorists who might seek to use toxic chemicals to inflict mass  casualties in the United States. These chemicals could be released from  a facility to cause harm to surrounding populations; they could be stolen  and used as chemical weapons or as their precursors (the ingredients for  making chemical weapons); or they could be stolen and used to build an  improvised explosive device. Past incidents remind us of the danger that  these chemicals pose, including the 2013 ammonium nitrate explosion at  a fertilizer storage and distribution facility in West, Texas, which killed at  least 14 people and damaged or destroyed at least 200 homes, and the  1995 domestic terrorist attack on the federal building in Oklahoma City,  Oklahoma, where 168 people were killed using ammonium nitrate  fertilizer mixed with fuel oil.

The Department of Homeland Security Appropriations Act, 2007, required  DHS to issue regulations to establish risk-based performance standards  (performance standards) for securing high-risk chemical facilities. DHS  subsequently established the CFATS program in 2007 to, among other  things, identify high-risk chemical facilities and assess the risk posed by  them; place facilities considered to be high-risk into one of four risk-based  tiers (with tier 1 being the highest risk tier and 4 being the lowest); assess  facility security; approve security plans prepared by facilities; and inspect  facilities to ensure compliance with regulatory requirements. DHS’s  CFATS rule established 18 performance standards that identify the areas  for which a facility’s security posture are to be examined, such as  perimeter security, access control, and cyber security. To meet these  standards, facilities are free to choose whatever security programs or  processes they deem appropriate so long as DHS determines that the  facilities achieve the requisite level of performance in each of the  applicable areas. The Protecting and Securing Chemical Facilities from  Terrorist Attacks Act of 2014 (CFATS Act of 2014), enacted in December  2014, in effect, reauthorized the CFATS program for an additional 4  years, while also imposing additional implementation requirements on  DHS for the program. In January 2019, the Chemical Facility Anti- Terrorism Standards Program Extension Act, was enacted and extended  the authorization by 15 months.

DHS’s Cybersecurity and Infrastructure Security Agency’s Infrastructure  Security Compliance Division (ISCD) manages the CFATS program.  According to DHS, the department received approximately $911 million  for the CFATS program for the period beginning fiscal year 2007 through  fiscal year 2018.

My testimony today summarizes our past work examining DHS’s  management of the CFATS program, and provides updates on actions  DHS has taken to address our prior recommendations. This testimony is  based on our reports issued from July 2012 through August 2018. For these reports, we reviewed applicable laws and regulations, DHS policies  and procedures, DHS data on tiered facilities, information on the  approach DHS used to determine a facility’s risk, and process for  reviewing security plans. We also interviewed DHS officials about how  facilities are placed in risk-based tiers, how DHS assesses risk, and how  it reviews and approves facility security plans. Additional details on the  scope and methodology are available in our published reports. In  addition, this statement contains updates as of September 2018 from  DHS on actions it has taken to address the recommendations made in  our prior reports.

The work upon which this statement is based was conducted 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.

DHS Has Made Progress Addressing Past Challenges, But Some Actions are Still Under Way

Our past work has identified progress and challenges in a number of  areas related to DHS’s management of the CFATS program, including (1)  the process for identifying high-risk chemical facilities; (2) how it assesses  risk and prioritizes facilities; (3) reviewing and approving facility site  security plans; (4) inspecting facilities and ensuring compliance; and (5)  efforts to conduct outreach with stakeholders and first responders.

Identifying High-Risk Chemical Facilities

In May 2014, we found that more than 1,300 facilities had reported having  ammonium nitrate to DHS. However, based on our review of state data  and records, there were more facilities with ammonium nitrate holdings  than those that had reported to DHS under the CFATS program. Thus,  we concluded that some facilities weren’t required to report to DHS and  some that were required may have failed to do so. We recommended  that DHS work with other agencies, including the Environmental  Protection Agency (EPA), to develop and implement methods of  improving data sharing among agencies and with states as members of a  Chemical Facility Safety and Security Working Group. DHS agreed with  our recommendation and has since addressed it. Specifically, DHS  compared DHS data with data from other federal agencies, such as EPA,  as well as member states from the Chemical Facility Safety and Security  Working Group to identify potentially noncompliant facilities. As a result of  this effort, in July 2015, DHS officials reported that they had identified  about 1,000 additional facilities that should have reported information to  comply with CFATS and subsequently contacted these facilities to ensure  compliance. DHS officials told us that they continue to engage with states  to identify potentially non-compliant facilities. For example, as of June  2018, DHS officials stated that they have received 43 lists of potentially  noncompliant facilities from 34 state governments, which are in various  stages of review by DHS. DHS officials also told us that they hired an  individual to serve as the lead staff member responsible for overseeing  this effort.

DHS has also taken action to strengthen the accuracy of data it uses to  identify high-risk facilities. In July 2015, we found that DHS used self- reported and unverified data to determine the risk categorization for  facilities that held toxic chemicals that could threaten surrounding  communities if released. At the time, DHS required that facilities self- report the Distance of Concern—an area in which exposure to a toxic  chemical cloud could cause serious injury or fatalities from short-term  exposure—as part of its Top-Screen. We estimated that more than  2,700 facilities with a toxic release threat had misreported the Distance of  Concern and therefore recommended that DHS (1) develop a plan to  implement a new Top-Screen to address errors in the Distance of  Concern submitted by facilities, and (2) identify potentially miscategorized  facilities that could cause the greatest harm and verify that the Distance  of Concern of these facilities report is accurate. DHS has fully  addressed both of these recommendations. Specifically, in response to  the first recommendation, DHS implemented an updated Top-Screen  survey in October 2016 and now collects data from facilities and conducts  more accurate modeling to determine the actual area of impact (formerly  called the Distance of Concern), rather than relying on the facilities’  calculation. In response to the second recommendation, DHS officials  reported in November 2016 that they reassessed all facility Top-Screens  that reported threshold quantities of chemicals posing a toxic release  threat, and identified 158 facilities with the potential to cause the greatest  harm. In April 2018, DHS officials reported that all of these facilities have  since been reassessed using updated Top-Screen information and,  where appropriate, assigned a risk tier.

Assessing Risk and Prioritizing Facilities

DHS has also taken actions to better assess regulated facilities’ risks in  order to place the facilities into the appropriate risk tier. In April 2013, we  reported that DHS’s risk assessment approach did not consider all of the  elements of threat, vulnerability, and consequence associated with a  terrorist attack involving certain chemicals. Our work showed that DHS’s  CFATS risk assessment methodology was based primarily on  consequences from human casualties, but did not consider economic  consequences, as called for by the National Infrastructure Protection Plan  (NIPP) and the CFATS regulation. We also found that (1) DHS’s  approach was not consistent with the NIPP because it treated every  facility as equally vulnerable to a terrorist attack regardless of location or  on-site security and (2) DHS was not using threat data for 90 percent of  the tiered facilities—those tiered for the risk of theft or diversion—and  using 5-year-old threat data for the remaining 10 percent of those facilities  that were tiered for the risks of toxic chemical release or sabotage. We  recommended that DHS enhance its risk assessment approach to  incorporate all elements of risk and conduct an independent peer review  after doing so. DHS agreed with our recommendations and has  implemented actions to address both of them.

Specifically, with regard to our recommendation that DHS enhance its risk  assessment approach to incorporate all elements of risk, DHS worked  with Sandia National Laboratories to develop a model to estimate the  economic consequences of a chemical attack. In addition, DHS worked  with Oak Ridge National Laboratory to devise a new tiering methodology,  called the Second Generation Risk Engine. In so doing, DHS revised the  CFATS threat, vulnerability, and consequence scoring methods to better  cover the range of CFATS security issues. Additionally, with regard to our  recommendation that DHS conduct a peer review after enhancing its risk  assessment approach, DHS conducted peer reviews and technical  reviews with government organizations and facility owners and operators,  and worked with Sandia National Laboratories to verify and validate the  CFATS program’s revised risk assessment methodology.

To further enhance its risk assessment approach, in the fall of 2016, DHS  also revised its Chemical Security Assessment Tool (CSAT), which  supports DHS efforts to gather information from facilities to assess their  risk. According to DHS officials, the new tool—called CSAT 2.0—is  intended to eliminate duplication and confusion associated with DHS’s  original CSAT. DHS officials told us that they have improved the tool by  revising some questions in the original CSAT to make them easier to  understand; eliminating some questions; and pre-populating data from  one part of the tool to another so that users do not have to retype the  same information multiple times. DHS officials also told us that the  facilities that have used the CSAT 2.0 have provided favorable feedback  that the new tool is more efficient and less burdensome than the original  CSAT. Finally, DHS officials told us that, as of June 2018, DHS  completed all notifications and processed tiering results for all but 226  facilities. DHS officials did not provide an estimated target completion  date for these pending risk assessments, noting that completing the  assessments is highly dependent on the facilities providing the necessary  Top-Screen information.

Reviewing and Approving Facility Site Security Plans

DHS has also made progress reviewing and approving facility site  security plans by reducing the time it takes to review these plans and  eliminating the backlog of plans awaiting review. In April 2013, we  reported that DHS revised its procedures for reviewing facilities’ security  plans to address DHS managers’ concerns that the original process was  slow, overly complicated, and caused bottlenecks in approving plans.  We estimated that it could take DHS another 7 to 9 years to review the  approximately 3,120 plans in its queue at that time. We also estimated  that, given the additional time needed to do compliance inspections, the  CFATS program would likely be implemented in 8 to 10 years. We did not  make any recommendations for DHS to improve its procedures for  reviewing facilities’ security plans because DHS officials reported that  they were exploring ways to expedite the process, such as reprioritizing  resources and streamlining inspection requirements. In July 2015, we  reported that DHS had made substantial progress in addressing the  backlog—estimating that it could take between 9 and 12 months for DHS  to review and approve security plans for the approximately 900 remaining  facilities. DHS officials attributed the increased approval rate to  efficiencies in DHS’s review process, updated guidance, and a new case  management system. Subsequently, DHS reported in its December 2016  semi-annual report to Congress that it had eliminated its approval  backlog.

Finally, we found in our 2017 review that DHS took action to implement  an Expedited Approval Program (EAP). The CFATS Act of 2014  required that DHS create the EAP as another option that tier 3 and tier 4  chemical facilities may use to develop and submit security plans to  DHS. Under the program, these tier 3 and 4 facilities may develop a  security plan based on specific standards published by DHS (as opposed  to the more flexible performance standards using the standard, non- expedited process). DHS issued guidance intended to help facilities  prepare and submit their EAP security plans to DHS, which includes an  example that identifies prescriptive security measures that facilities are to  have in place. According to committee report language, the EAP was  expected to reduce the regulatory burden on smaller chemical  companies, which may lack the compliance infrastructure and the  resources of large chemical facilities, and help DHS to process security  plans more quickly. If a tier 3 or 4 facility chooses to use the expedited  option, DHS is to review the plan to determine if it is facially deficient,  pursuant to the reporting requirements of the CFATS Act of 2014. If  DHS approves the EAP site security plan, it is to subsequently conduct a  compliance inspection.

In 2017, we found that DHS had implemented the EAP and had reported  to Congress on the program, as required by the CFATS Act of 2014. In addition, as of June 2018, according to DHS officials, only 18 of the 3,152  facilities eligible to use the EAP had opted to use it. DHS officials  attributed the low participation to several possible factors including:

DHS had implemented the expedited program after most eligible  facilities already submitted standard (non-expedited) security plans to  DHS;  facilities may consider the expedited program’s security measures to  be too strict and prescriptive, not providing facilities the flexibility of  the standard process; and  the lack of an authorization inspection may discourage some facilities  from using the expedited program because this inspection provides  useful information about a facility’s security.

We also found in 2017 that recent changes made to the CFATS program  could affect the future use of the expedited program. As discussed  previously, DHS has revised its methodology for determining the level of  each facility’s security risk, which could affect a facility’s eligibility to  participate in the EAP.

Inspecting Facilities and Ensuring Compliance

In our July 2015 report, we found that DHS began conducting compliance  inspections in September 2013, and by April 2015, had conducted  inspections of 83 of the inspected 1,727 facilities that had approved  security plans. Our analysis showed that nearly half of the facilities were  not fully compliant with their approved site security plans and that DHS  had not used its authority to issue penalties because DHS officials found  it more productive to work with facilities to bring them into compliance.  We also found that DHS did not have documented processes and  procedures for managing the compliance of facilities that had not  implemented planned measures by the deadlines outlined in their plans.  We recommended that DHS document processes and procedures for  managing compliance to provide more reasonable assurance that  facilities implement planned measures and address security gaps. DHS  agreed and has since taken steps toward implementing this  recommendation. Specifically, DHS revised CFATS Standard Operating  Procedures that, as of February 2019, we are reviewing to determine if  they sufficiently document the processes and procedures currently being  used to track noncompliant facilities and ensure facilities implement  planned measures as outlined in their approved site security plans.

In August 2018, we reported that our analysis of DHS data since our 2015  report showed that DHS has made substantial progress in conducting and  completing compliance inspections. Specifically, our analysis showed  that DHS increased the number of compliance inspections completed per  year since DHS began conducting compliance inspections in 2013 and  that, for the 2,466 high-risk facilities with an approved site security plan as  of May 2018, DHS had conducted 3,553 compliance inspections. Of  these, DHS issued corrective actions to two facilities that were not in  compliance with their approved site security plan.

In our August 2018 report, we also found that DHS developed a new  methodology and performance measure for the CFATS program in order  to evaluate security changes made by high-risk chemical facilities, but  that the methodology does not measure the program’s impact on  reducing a facility’s vulnerability to an attack. We found that DHS could  take steps to evaluate vulnerability reduction resulting from the CFATS  compliance inspection process. We recommended that DHS incorporate  vulnerability into the new methodology to help measure the reduction in  the vulnerability of high-risk facilities to a terrorist attack, and use that  data in assessing the CFATS program’s performance in lowering risk and  enhancing national security. DHS agreed and is taking steps to  implement this recommendation. Specifically, in September 2018, DHS  reported making progress towards the implementation of two new  performance metrics by the end of the first quarter of fiscal year 2019.  DHS officials stated that these metrics should, among other things,  evaluate the progress of individual facilities in enhancing their security  while part of the CFATS program and be used to demonstrate an  increase in the security posture across the population of CFATS facilities.

Conducting Stakeholder and First Responder Outreach

In April 2013, we reported that DHS took various actions to work with  facility owners and operators, including increasing the number of visits to  facilities to discuss enhancing security plans, but that some trade  associations had mixed views on the effectiveness of DHS’s outreach.  We found that DHS solicited informal feedback from facility owners and  operators in its efforts to communicate and work with them, but did not  have an approach for obtaining systematic feedback on its outreach  activities. We recommended that DHS take action to solicit and document  feedback on facility outreach consistent with DHS efforts to develop a  strategic communication plan. DHS agreed and has implemented this  recommendation by developing a questionnaire to solicit feedback on  outreach with industry stakeholders and began using the questionnaire in  October 2016.

In August 2018, we reported that DHS shares some CFATS information  with first responders and emergency planners, but these stakeholders  may not have all of the information they need to minimize the risk of injury  or death when responding to incidents at high-risk facilities. While  certain facilities are required under the Emergency Planning and  Community Right-to-Know Act of 1986 to report some chemical inventory  information, which local officials told us they rely on to prepare for and  respond to incidents at chemical facilities, we found over 200 chemicals  covered by CFATS that may not be covered by these reporting  requirements. We also reported that DHS developed a secure interface  called the Infrastructure Protection (IP) Gateway that provides access to  CFATS facility-specific information that may be missing from required reporting. However, we found that the IP Gateway is not widely used at  the local level and officials from 13 of 15 selected Local Emergency  Planning Committees we contacted—consisting of first responders and  covering 373 CFATS high-risk facilities—said they did not have access to  CFATS data in the IP Gateway. We recommended that DHS should take  actions to encourage access to and wider use of the IP Gateway and  explore other opportunities to improve information-sharing with first  responders and emergency planners. DHS concurred with this  recommendation and reported in September 2018 that they are taking  actions to implement it. Specifically, DHS has revised three fact sheets  and an outreach presentation to include information on the IP Gateway  and how to request access to it. In addition, DHS plans to ensure contact  is made with first responders representing the top 25 percent of CFATS  high-risk chemical facilities by no later than March 2019 so that they are  properly prepared to respond to incidents at these facilities.

Chairman Thompson, Ranking Member Rogers, and Members of the  Committee, this completes my prepared statement. I would be pleased to  respond to any questions that you may have at this time.

If you or your staff members have any questions about this testimony,  please contact me at (202) 512-3841 or andersonn@gao.gov. Contact  points for our Offices of Congressional Relations and Public Affairs may  be found on the last page of this statement. Other individuals making key  contributions to this work include Ben Atwater, Assistant Director; Hugh  Paquette, Analyst-in-Charge; Chuck Bausell, Michele Fejfar, Tracey King,  and Tom Lombardi.

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Thousands of U.S. facilities handle hazardous chemicals and could be targets for terrorists—e.g., the chemicals could be stolen and used to build explosive devices.

The Department of Homeland Security identifies and assesses the security risk of these facilities. We've made a number of recommendations in the past to help DHS address challenges it faces in doing so.

We testified that DHS has made progress on our recommendations. For example, DHS began to calculate the risk of toxic chemical release rather than relying on individual facilities to do it. Additionally, DHS eliminated its backlog of facility security plan reviews.