	DHS and the White House Have Taken Action to Enhance Biosurveillance

In December 2009, we published a report assessing DHS’s efforts to  establish the National Biosurveillance Integration Center (NBIC). We  reported that NBIC was not fully equipped to carry out its mission  because it lacked key resources—data and personnel—from its partner  agencies, a situation that could be at least partially attributed to  collaboration challenges NBIC faced. In August  2012, DHS issued the National Biosurveillance Integration Center  Strategic Plan. In June 2010, we reported on federal efforts that support a national  biosurveillance capability and the extent to which mechanisms were in  place to guide the development of a national biosurveillance capability. The  White House did not comment on these recommendations. In July 2012, the White House released the National Strategy for  Biosurveillance to describe the U.S. government’s approach to  strengthening biosurveillance. The strategy describes guiding principles,  core functions, and enablers for strengthening biosurveillance. A strategic implementation plan is to be  completed within 120 days of the strategy issuance. The strategy does  not fully meet the intent of our June 2010 and October 2011  recommendations, as discussed later in this statement, but it is possible  that it will when the implementation plan is complete. DHS Did Not Develop Critical Knowledge before Proceeding with the Gen-3 Acquisition

		DHS Proceeded with the Gen-3 Acquisition before Establishing a Mission Need

DHS approved the Gen-3 acquisition in October 2009 without fully  developing critical knowledge that would help ensure sound investment  decision making, pursuit of optimal solutions, and reliable performance,  cost, and schedule information. DHS Did Not Fully Develop Performance, Cost, and Schedule Information

In October 2009, DHS approved the Gen-3 acquisition at Acquisition  Decision Event (ADE) 2A—one of the key formal decision points in DHS’s  Acquisition Life-cycle Framework—based on information contained in  acquisition documents provided by the BioWatch program. Further, we reported  that some performance, cost, and schedule expectations presented at  ADE-2A were not developed in accordance with DHS guidance and good  acquisition practices—like accounting for risk in schedule and cost  estimates. Specifically, certain performance  requirements have been revised, the estimated date for full deployment  has been delayed from fiscal year 2016 to fiscal year 2022, and the  expected life cycle cost has changed from the $2.1 billion point estimate  prepared for ADE-2A to a risk-adjusted $5.8 billion estimate, calculated at  the 80 percent confidence level. We recommended that before continuing the acquisition, DHS reevaluate  the mission need and alternatives and develop performance, cost, and  schedule information in accordance with guidance and good acquisition  practices. DHS concurred with the recommendations but plans to proceed  with the next step in the acquisition—performance testing—while  implementing them. Several Steps Remain before Gen-3 Is Ready for Deployment

The BioWatch program completed initial testing and evaluation on a Gen- 3 prototype technology in June 2011, but several steps remain before   For example, the BioWatch  Gen-3 can be deployed and operational.program must complete additional testing. Observations about Prior Strategy Recommendations and the July 2012 National Strategy for Biosurveillance

In the report on Gen-3 released today, we noted that beyond the  uncertainty related to the costs and benefits of the planned Gen-3  approach, there is additional uncertainty about the incremental benefit of  this kind of environmental monitoring as a risk mitigation activity because  of its relatively limited scope. Rather, we believe  the need to consider value within the larger biosurveillance enterprise as  part of an effort to define mission need for a single federal program like  Gen-3 provides a timely and concrete illustration of the kind of issues we  sought to address with our June 2010 recommendation. The  recommendation for the Homeland Security Council to direct the National  Security Staff to identify a focal point to lead the development of a  national biosurveillance strategy was grounded in previous work on  desirable strategy characteristics for complex homeland security  missions. We recognized the difficulty that decision makers and program  managers in individual federal agencies face prioritizing resources to help  ensure a coherent effort across a vast and dispersed interagency,  intergovernmental, and intersectoral network. However, the strategy does not yet offer a mechanism to identify resource  and investment needs, including investment priorities among these  various efforts. Accordingly, the enterprise is still without a framework to  guide the systematic identification of risk, assessment of resources  needed to address those risks, and the prioritization and allocation of  investment across the entire biosurveillance enterprise, as we  recommended in June 2010. We are encouraged by the National Strategy for Biosurveillance and the  work the White House has done to date to provide a platform for  achieving a well-integrated national biosurveillance enterprise.
Why GAO Did This Study

A catastrophic biological event could have devastating consequences. The U.S. government has efforts to provide early detection and warning of biological threats. DHSs BioWatch, which aims to detect certain pathogens in the air, is one such program. DHS has been pursuing a third generation of BioWatch technology (Gen-3) to further enhance detection. GAO has published a series of reports on national biosurveillance efforts, including a report released today on DHSs efforts to acquire Gen-3. This statement discusses (1) prior biosurveillance work and related federal efforts, (2) todays report on the Gen-3 acquisition, and (3) prior strategy recommendations and the White Houses July 2012 National Strategy for Biosurveillance. This statement is based on GAO reports published from December 2009 to September 2012 and GAOs review of the National Strategy for Biosurveillance in relation to prior GAO recommendations for a national biosurveillance strategy.

What GAO Found

The Department of Homeland Security (DHS) and the White House have acted to strengthen biosurveillance consistent with prior GAO recommendations made from December 2009 through October 2011.In August 2012, DHS issued a strategic plan for its National Biosurveillance Integration Center (NBIC) that officials say was written in coordination with federal partners and designed to respond to GAOs December 2009 findings that NBIC did not have key resources to carry out its mission, in part due to collaboration issues it faced. In July 2012, the White House released the National Strategy for Biosurveillance, which describes guiding principles, core functions, and enablers for strengthening biosurveillance. In June 2010, GAO recommended a national biosurveillance strategy to provide a unifying framework for building and maintaining a national biosurveillance capability. In October 2011, GAO also recommended the strategy account for the need to leverage resources and respond to challenges while partnering with nonfederal entities. The July 2012 strategy partially responds to the issues GAO called for such a strategy to address, but does not fully address them, as discussed below. A strategic implementation plan is to be published within 120 days of strategy issuance (October 2012), and may align the strategy more fully with the array of issues GAO identified.
DHS approved the Generation-3 (Gen-3) acquisition in October 2009, but it did not fully engage its acquisition framework to ensure that the acquisition was grounded in a justified mission need and that it pursued an optimal solution. The performance, schedule, and cost expectations presented in required documents when DHS approved the acquisition were not developed in accordance with DHS guidance and good acquisition practiceslike accounting for risk in schedule and cost estimates. Since October 2009, the estimated date for full deployment has been delayed from fiscal year 2016 to fiscal year 2022. The 2009 life-cycle cost estimatea point estimate unadjusted for riskwas $2.1 billion. In June 2011, DHS provided a risk-adjusted estimate at the 80 percent confidence level of $5.8 billion. Several steps remain before DHS can fully deploy Gen-3 including additional performance testing, operational testing, and developing location specific deployment plans.
The White Houses National Strategy for Biosurveillance serves as a foundation for enterprisewide efforts and begins to define mission, goals, and objectives, as we called for in making the June 2010 strategy recommendation; however, the strategy does not yet offer the mechanism GAO recommended to identify resource and investment needs, including investment priorities. Accordingly, the biosurveillance enterprise remains without a framework to guide the systematic identification of risk, assessment of resources needed to address those risks, and the prioritization and allocation of investment across the entire enterprise. In recommending a national strategy, GAO recognized the challenges individual federal programs and agencies face prioritizing resources to help ensure a coherent effort across the dispersed biosurveillance enterprise. Todays report on Gen-3 offers a timely and concrete example of this challengeto assess the extent to which Gen-3 warrants the investment of scarce resources when the incremental value of the environmental monitoring Gen-3 offers is considered as part of a layered biosurveillance strategy.

What GAO Recommends

In prior reports, GAO made biosurveillance recommendations to DHS and the White House Homeland Security Council. DHS concurred with prior recommendations. The White House did not comment. In todays report, GAO recommended that before continuing the Gen-3 acquisition, DHS reevaluate the mission need and alternatives and update associated performance, schedule, and cost information. DHS concurred but stated it plans to reevaluate the acquisition and pursue performance testing concurrently. We believe DHS should first develop the critical information we recommended.