DHS Office of Inspector General: Preliminary Observations on Long-Standing Management and Operational Challenges

What GAO Found

GAO’s preliminary work has identified a number of management and operational challenges, including frequent leadership turnover, since fiscal year 2015 that have impeded the overall effectiveness of the Department of Homeland Security (DHS) Office of Inspector General (OIG). DHS OIG senior leaders have acknowledged that these challenges have contributed to organizational weaknesses, and have taken steps to begin addressing some of them. GAO’s preliminary work has identified issues in the following areas, among others:

  • Strategic planning: DHS OIG has not consistently developed strategic plans, which are a necessary input for developing the organization’s other guiding documents and governance framework. Specifically, DHS OIG has operated for 4 of the past 6 years without a strategic plan, and the plan it adopted for fiscal years 2018–2019 included some, but not all, of the elements considered standard for federal entities. In 2020, DHS OIG contracted with a nonprofit academy of government experts to develop a strategic plan for fiscal years 2021–2025, with expected delivery in June 2021.
  • Quality assurance: Internal and external reviews have reported on concerns about quality assurance in some of DHS OIG’s work. In 2017 and 2018, after an internal review found that some reports issued by DHS OIG may not have adhered to the professional standards cited, DHS OIG retracted 13 audit reports that had been issued over a 5-year period. In 2018, an external review determined that DHS OIG needed to improve its system of quality control. Though DHS OIG concurred with all of the recommendations from that external review, it did not fully implement them. In addition, DHS OIG has not established roles and responsibilities for an organization-wide quality assurance program. Moreover, GAO’s preliminary work indicates that current staff allocations may limit DHS OIG’s quality assurance reviews to focusing on audit work and not on the other types of work it produces, including inspections, evaluations, special reviews, and management alerts.
  • Timeliness: DHS OIG project time frames for work from its offices of Audits and Special Reviews and Evaluations have increased over the 4 fiscal years GAO assessed. For example, in fiscal year 2017, 79 of 102 Office of Audits projects were completed in 1 year or less and eight of 102 took more than 18 months. In fiscal year 2020, seven of 67 reports were completed in 1 year or less and more than half (35 of 67) took more than 18 months. In addition, DHS OIG has not assessed time frames for work completed by these offices, though timeliness in reporting is a key element of effective oversight and DHS OIG staff considered it an organizational weakness.

GAO will complete its evaluation of these and other management and operational areas, and will issue a final report in the coming months.

Why GAO Did This Study

DHS OIG has a critical role in providing independent and objective oversight of DHS, which encompasses multiple operational and support components. OIGs are expected to maintain high standards of professionalism and integrity in light of their mission, according to quality standards developed by the community of federal Inspectors General. However, DHS OIG has faced a number of challenges that have affected its ability to carry out its oversight mission effectively.

This statement is based on GAO’s draft report on DHS OIG’s management and operations, which is currently at the agency for comment. It provides preliminary observations on DHS OIG’s strategic planning processes; quality assurance processes; and reporting time frames for work from DHS OIG’s offices of Audits and Special Reviews and Evaluations.

To develop these preliminary observations, GAO reviewed relevant federal laws and quality standards for federal OIGs as well as DHS OIG documentation, including organizational policies; internal communications such as emails and memoranda; and DHS OIG’s semiannual reports to Congress and published reports. GAO also analyzed DHS OIG project data from fiscal years 2015 through 2020, and interviewed DHS OIG leaders and other staff.

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Vaccine Platform Technologies Supported by Operation Warp Speed, as of January 2021 As of January 30, 2021, five of the six OWS vaccine candidates have entered phase 3 clinical trials, two of which—Moderna's and Pfizer/BioNTech's vaccines—have received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). For vaccines that received EUA, additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical trials already underway before the EUA was issued. Technology readiness. GAO's analysis of the OWS vaccine candidates' technology readiness levels (TRL)—an indicator of technology maturity— showed that COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations. FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines. To meet OWS timelines, some vaccine companies relied on data from other vaccines using the same platforms, where available, or conducted certain animal studies at the same time as clinical trials. However, as is done in a non-pandemic environment, all vaccine companies gathered initial safety and antibody response data with a small number of participants before proceeding into large-scale human studies (e.g., phase 3 clinical trials). The two EUAs issued in December 2020 were based on analyses of clinical trial participants and showed about 95 percent efficacy for each vaccine. These analyses included assessments of efficacy after individuals were given two doses of vaccine and after they were monitored for about 2 months for adverse events. Manufacturing. As of January 2021, five of the six OWS vaccine companies had started commercial scale manufacturing. OWS officials reported that as of January 31, 2021, companies had released 63.7 million doses—about 32 percent of the 200 million doses that, according to OWS, companies with EUAs have been contracted to provide by March 31, 2021. Vaccine companies face a number of challenges in scaling up manufacturing to produce hundreds of millions of doses under OWS's accelerated timelines. DOD and HHS are working with vaccine companies to help mitigate manufacturing challenges, including: Limited manufacturing capacity: A shortage of facilities with capacity to handle the vaccine manufacturing needs can lead to production bottlenecks. Vaccine companies are working in partnership with OWS to expand production capacity. For example, one vaccine company told GAO that HHS's Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production. Additionally, the U.S. Army Corps of Engineers is overseeing construction projects to expand capacity at vaccine manufacturing facilities. Disruptions to manufacturing supply chains: Vaccine manufacturing supply chains have been strained by the global demand for certain goods and workforce disruptions caused by the global pandemic. For example, representatives from one facility manufacturing COVID-19 vaccines stated that they experienced challenges obtaining materials, including reagents and certain chemicals. They also said that due to global demand, they waited 4 to 12 weeks for items that before the pandemic were typically available for shipment within one week. Vaccine companies and DOD and HHS officials told GAO they have undertaken several efforts to address possible manufacturing disruptions and mitigate supply chain challenges. These efforts include federal assistance to (1) expedite procurement and delivery of critical manufacturing equipment, (2) develop a list of critical supplies that are common across the six OWS vaccine candidates, and (3) expedite the delivery of necessary equipment and goods coming into the United States. Additionally, DOD and HHS officials said that as of December 2020 they had placed prioritized ratings on 18 supply contracts for vaccine companies under the Defense Production Act, which allows federal agencies with delegated authority to require contractors to prioritize those contracts for supplies needed for vaccine production. Gaps in the available workforce: Hiring and training personnel with the specialized skills needed to run vaccine manufacturing processes can be challenging. OWS officials stated that they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas. OWS officials also stated that they requested that 16 DOD personnel be detailed to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire the required personnel. As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions, with the unemployment rate and number of unemployed in January 2021 at nearly twice their pre-pandemic levels in February 2020. In May 2020, OWS was launched and included a goal of producing 300 million doses of safe and effective COVID-19 vaccines with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goal. Such vaccines are crucial to mitigate the public health and economic impacts of the pandemic. GAO was asked to review OWS vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges. GAO administered a questionnaire based on HHS's medical countermeasures TRL criteria to the six OWS vaccine companies to evaluate the COVID-19 vaccine development processes. GAO also collected and reviewed supporting documentation on vaccine development and conducted interviews with representatives from each of the companies on vaccine development and manufacturing. For more information, contact Karen L. Howard and Candice N. Wright at (202) 512-6888 or howardk@gao.gov or wrightc@gao.gov.
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