In July, the Government Accountability Office said that the National Biodefense Strategy — issued by the White House in September 2018 — was still too young to pass judgment on implementation or assess how responsible agencies were moving forward with limited biodefense resources.
On Wednesday, the GAO assessed that “challenges with planning to manage change, limited guidance and methods for analyzing capabilities, and lack of clarity about decision-making processes, roles, and responsibilities” imperiled successful implementation of the plan to protect the country from biothreats.
The National Biodefense Strategy, a multiagency effort overseen by the Department of Health and Human Services, was issued with the goal of “a more efficient, coordinated, and accountable biodefense enterprise” established by setting up “a process to assess our capabilities and to prioritize biodefense resources and actions across the government.” The strategy, which covers biowarfare, accidental release of pathogens and naturally occurring outbreaks, “builds on lessons learned from past biological incidents to develop a more resilient and effective biodefense enterprise” including the 2001 anthrax attacks, the 2009 influenza pandemic, the 2014 Ebola epidemic, and the Zika epidemic.
At a Hudson Institute forum last week on challenges in containing the coronavirus, former Sen. Joe Lieberman (I-Conn.), co-chairman of the Bipartisan Commission on Biodefense, called the National Biodefense Strategy “a good document,” but said the commission is concerned that “implementation of it has slowed a bit more than it should be.”
The GAO’s new report said “a number of challenges… could limit long-term implementation success” of the strategy, including “no documented methodology or guidance for how data are to be analyzed to help the enterprise identify gaps and opportunities to leverage resources, including no guidance on how nonfederal capabilities are to be accounted for in the analysis.”
“Many of the resources that compose national capabilities are not federal, so enterprise-wide assessment efforts should account for nonfederal capabilities,” the report said. “Agency officials were also unsure how decisions would be made, especially if addressing gaps or opportunities to leverage resources involved redirecting resources across agency boundaries. Although HHS officials pointed to existing processes and directives for interagency decision making, GAO found there are no clear, detailed processes, roles, and responsibilities for joint decision-making, including how agencies will identify opportunities to leverage resources or who will make and enforce those decisions.”
Because of this lack of clarity, GAO said, “questions remain about how this first-year effort to catalogue all existing activities will result in a decisionmaking approach that involves jointly defining and managing risk at the enterprise level.”
“Without clearly documented methods, guidance, processes, and roles and responsibilities for enterprise-wide decision-making, the effort runs the risk of failing to move away from traditional mission stovepipes toward a strategic enterprise-wide approach that meaningfully enhances national capabilities.”
Officials from the eight agencies interviewed by GAO (HHS, USDA, DOD, DHS, State, VA, Justice, and EPA) reported first-year data-collection challenges with staffing and organizational resources, quantifying biodefense activities, and technology glitches. One unnamed agency said that their part of the biodefense effort didn’t have any full-time staff and “was seen as a collateral duty competing with regular priorities, which reduced the time devoted to identifying the necessary information.”
“The agencies involved in implementing the Strategy do not have a plan that includes change management practices that can help prevent these challenges from being carried forward into future efforts, and help reinforce enterprise-wide approaches, among other things,” GAO said. “…Officials at one large agency told us they treated the first year as a learning experience and that in the coming years, when agencies have sufficient time to respond to the data call, the quality of the data submitted should improve. Some officials we interviewed voiced concern that this first-year effort could set a poor precedent for these activities in future years if the challenges are not acknowledged and addressed.”
GAO also found “a lack of clear procedures and planning to help ensure that the Biodefense Coordination Team is prepared to analyze the data, once it has been collected, in a way that that leads to recognition of meaningful opportunities to leverage resources in efforts to maintain and advance national biodefence capabilities.” That team also “was not explicitly required to analyze nonfederal resources and there was no guidance that would help ensure agencies consistently and systematically included the contributions of nonfederal capabilities.” Not all agencies were able to provide a full-time representative to the team, as well.
HHS requested $5 million in fiscal year 2020 for administrative costs to implement the strategy, but did not receive the funds.
GAO noted that the “cultural shift” toward agencies working together on biodefense — joint decision-making and budget tradeoffs included — “may take years to fully develop.”
GAO recommended that HHS “direct the Biodefense Coordination Team to establish a plan that includes change management practices — such as strategies for feedback, communication, and education — to reinforce collaborative behaviors and enterprise-wide approaches and to help prevent early implementation challenges from becoming institutionalized,” and also direct the team “to clearly document guidance and methods for analyzing the data collected from the agencies, including ensuring that nonfederal resources and capabilities are accounted for in the analysis.”
The Biodefense Coordination Team should “establish a resource plan to staff, support, and sustain its ongoing efforts,” GAO added, and “clearly document agreed upon processes, roles, and responsibilities for making and enforcing enterprise-wide decisions.”
HHS concurred with the recommendations and said they were taking steps to meet the goals, yet GAO noted that a a funding resource was still needed for the operations of the Biodefense Coordination Team.