oversight

Biosurveillance: Observations on BioWatch Generation-3 and Other Federal Efforts

Published by the Government Accountability Office on 2012-09-13.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                            United States Government Accountability Office


GAO                         Testimony
                            Before the Subcommittees on Emergency Preparedness,
                            Response, and Communications and Cybersecurity,
                            Infrastructure Protection, and Security Technologies
                            Committee on House Homeland Security, House of
                            Representatives

                            BIOSURVEILLANCE
For Release on Delivery
Expected at 2:00 p.m. EDT
September 13, 2012



                            Observations on BioWatch
                            Generation-3 and Other
                            Federal Efforts
                            Statement of William O. Jenkins, Jr., Director
                            Homeland Security and Justice




GAO-12-994T
                                                    September 13, 2012

                                                    BIOSURVEILLANCE
                                                    Observations on BioWatch Generation-3 and Other
                                                    Federal Efforts
Highlights of GAO-12-994T, a testimony
before the Subcommittees on Emergency
Preparedness, Response, and Communications
and Cybersecurity, Infrastructure Protection, and
Security Technologies, Committee on Homeland
Security, House of Representatives

Why GAO Did This Study                              What GAO Found
A catastrophic biological event could               The Department of Homeland Security (DHS) and the White House have acted
have devastating consequences. The                  to strengthen biosurveillance consistent with prior GAO recommendations made
U.S. government has efforts to provide              from December 2009 through October 2011.In August 2012, DHS issued a
early detection and warning of                      strategic plan for its National Biosurveillance Integration Center (NBIC) that
biological threats. DHS’s BioWatch,                 officials say was written in coordination with federal partners and designed to
which aims to detect certain pathogens              respond to GAO’s December 2009 findings that NBIC did not have key resources
in the air, is one such program. DHS                to carry out its mission, in part due to collaboration issues it faced. In July 2012,
has been pursuing a third generation of             the White House released the National Strategy for Biosurveillance, which
BioWatch technology (Gen-3) to further
                                                    describes guiding principles, core functions, and enablers for strengthening
enhance detection. GAO has published
                                                    biosurveillance. In June 2010, GAO recommended a national biosurveillance
a series of reports on national
biosurveillance efforts, including a
                                                    strategy to provide a unifying framework for building and maintaining a national
report released today on DHS’s efforts              biosurveillance capability. In October 2011, GAO also recommended the strategy
to acquire Gen-3. This statement                    account for the need to leverage resources and respond to challenges while
discusses (1) prior biosurveillance                 partnering with nonfederal entities. The July 2012 strategy partially responds to
work and related federal efforts, (2)               the issues GAO called for such a strategy to address, but does not fully address
today’s report on the Gen-3                         them, as discussed below. A strategic implementation plan is to be published
acquisition, and (3) prior strategy                 within 120 days of strategy issuance (October 2012), and may align the strategy
recommendations and the White                       more fully with the array of issues GAO identified.
House’s July 2012 National Strategy
                                                    DHS approved the Generation-3 (Gen-3) acquisition in October 2009, but it did
for Biosurveillance. This statement is
based on GAO reports published from                 not fully engage its acquisition framework to ensure that the acquisition was
December 2009 to September 2012                     grounded in a justified mission need and that it pursued an optimal solution. The
and GAO’s review of the National                    performance, schedule, and cost expectations presented in required documents
Strategy for Biosurveillance in relation            when DHS approved the acquisition were not developed in accordance with DHS
to prior GAO recommendations for a                  guidance and good acquisition practices—like accounting for risk in schedule and
national biosurveillance strategy.                  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
What GAO Recommends                                 estimate—a point estimate unadjusted for risk—was $2.1 billion. In June 2011,
In prior reports, GAO made                          DHS provided a risk-adjusted estimate at the 80 percent confidence level of $5.8
biosurveillance recommendations to                  billion. Several steps remain before DHS can fully deploy Gen-3 including
DHS and the White House Homeland                    additional performance testing, operational testing, and developing location
Security Council. DHS concurred with                specific deployment plans.
prior recommendations. The White                    The White House’s National Strategy for Biosurveillance serves as a foundation
House did not comment. In today’s
                                                    for enterprisewide efforts and begins to define mission, goals, and objectives, as
report, GAO recommended that before
                                                    we called for in making the June 2010 strategy recommendation; however, the
continuing the Gen-3 acquisition, DHS
reevaluate the mission need and                     strategy does not yet offer the mechanism GAO recommended to identify
alternatives and update associated                  resource and investment needs, including investment priorities. Accordingly, the
performance, schedule, and cost                     biosurveillance enterprise remains without a framework to guide the systematic
information. DHS concurred but stated               identification of risk, assessment of resources needed to address those risks,
it plans to reevaluate the acquisition              and the prioritization and allocation of investment across the entire enterprise. In
and pursue performance testing                      recommending a national strategy, GAO recognized the challenges individual
concurrently. We believe DHS should                 federal programs and agencies face prioritizing resources to help ensure a
first develop the critical information we           coherent effort across the dispersed biosurveillance enterprise. Today’s report on
recommended.                                        Gen-3 offers a timely and concrete example of this challenge—to assess the
                                                    extent to which Gen-3 warrants the investment of scarce resources when the
View GAO-12-994T For more information,
contact William O. Jenkins at (202) 512-8757        incremental value of the environmental monitoring Gen-3 offers is considered as
or jenkinswo@gao.gov.                               part of a layered biosurveillance strategy.

                                                                                             United States Government Accountability Office
Chairmen Bilirakis and Lungren and members of the Subcommittees:

I am pleased to have the opportunity to be here today to discuss our
biosurveillance work, with particular focus on the Department of
Homeland Security’s (DHS) BioWatch Generation-3 (Gen-3) program. 1 A
catastrophic biological event, such as a terrorist attack with a weapon of
mass destruction or a naturally occurring pandemic, could cause
thousands of casualties or more, weaken the economy, damage public
morale and confidence, and threaten national security. In recent years,
there has been an increasing awareness of the potential for biological
agents to be used as weapons of mass destruction and of the threat of
catastrophic effects arising from emerging strains of infectious disease.
For example, events like the 2001 Amerithrax incident, which killed 5
people and sickened 17, and the global pandemic resulting from
emergence of a novel strain of influenza in 2009, have brought increased
attention to intentional and naturally occurring biological threats.

The U.S. government has a long history of employing disease
surveillance activities to help limit malady, loss of life, and economic
impact. Traditional disease surveillance activities involve trained
professionals engaged in monitoring, investigating, confirming, and
reporting in an effort to further various missions including, but not limited
to, detecting signs of pathogens in humans, animals, plants, food, and the
environment. However, in recent years, experts and practitioners,
reacting to an increasing awareness of the speed and intensity with which
a biological weapon of mass destruction or highly pathogenic strain of
emerging infectious disease could affect the nation, have sought to
augment traditional surveillance activities with biosurveillance programs
and systems. DHS’s BioWatch program is an example of such an effort. It
aims to reduce the time required to recognize and characterize potentially
catastrophic aerosolized attacks by detecting the presence of five
biological agents—considered to be at a high risk for weaponized
attack—in the air.

The currently deployed BioWatch technology—Generation-2 (Gen-2)—
can take 12 to 36 hours to confirm the presence of pathogens. DHS has


1
 The National Strategy for Biosurveillance defines “biosurveillance” as the process of
gathering, integrating, interpreting, and communicating essential information related to all-
hazards threats or disease activity affecting human, animal, or plant health to achieve
early detection and warning, contribute to overall situational awareness of the health
aspects of an incident, and enable better decision making at all levels.




Page 1                                                                          GAO-12-994T
been pursuing Gen-3 with the goal of implementing a system that will
perform automated testing, potentially generating a result in under 6
hours and eliminating certain labor costs. Expressing questions about
whether DHS had undertaken a rigorous effort to help guide its Gen-3
decision making, two subcommittees of this committee asked us to
examine issues related to the Gen-3 acquisition. Today, we released a
report that evaluates the acquisition decision-making process for Gen-3. 2
In addition, since December 2009, we have published three other reports
about efforts across the federal government and with nonfederal partners
to enhance the nation’s biosurveillance capabilities. 3 This statement (1)
describes recent federal efforts that align with our biosurveillance work
published from December 2009 through October 2011, (2) discusses our
Gen-3 acquisition findings, and (3) makes observations about our prior
strategy recommendations and the White House’s recently released
National Strategy for Biosurveillance.

To describe recent federal efforts that align with our work published from
December 2009 through October 2011, we reviewed the National
Biosurveillance Integration Center Strategic Plan and the National
Strategy for Biosurveillance, and obtained information from DHS officials.
To develop findings in the report released today about Gen-3, which this
statement is largely based on, we reviewed DHS’s acquisition guidance,
including Acquisition Management Directive 102-01. Additionally, we
reviewed acquisition documentation and interviewed agency officials from
the BioWatch program and other DHS offices with development, policy,
and acquisition responsibilities. We then compared the information
developed from our documentation review and interviews against the
guidance. More detailed information on our scope and methodology
appears in our published work .To make observations about the National
Strategy for Biosurveillance, we analyzed the strategy and assessed its
alignment with findings and recommendations about a the need for a
national biosurveillance strategy in prior work. We conducted this work



2
 GAO, Biosurveillance: DHS Should Reevaluate Mission Need and Alternatives before
Proceeding with BioWatch Generation-3 Acquisition, GAO-12-810 (Washington, D.C.:
Sept. 10, 2012).
3
 GAO, Biosurveillance: Developing a Collaboration Strategy Is Essential to Fostering
Interagency Data and Resource Sharing, GAO-10-171 (Washington, D.C.: Dec. 18, 2009);
Biosurveillance: Efforts to Develop a National Biosurveillance Capability Need a National
Strategy and a Designated Leader, GAO-10-645 (Washington, D.C.: June 30, 2010); and
Biosurveillance: Nonfederal Capabilities Should Be Considered in Creating a National
Biosurveillance Strategy, GAO-12-55 (Washington, D.C.: Oct. 31, 2011).




Page 2                                                                      GAO-12-994T
                    from August 2012 to September 2012 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.


                    In December 2009, we published a report assessing DHS’s efforts to
DHS and the White   establish the National Biosurveillance Integration Center (NBIC). We
House Have Taken    reported that NBIC was not fully equipped to carry out its mission
                    because it lacked key resources—data and personnel—from its partner
Action to Enhance   agencies, a situation that could be at least partially attributed to
Biosurveillance     collaboration challenges NBIC faced. We recommended that NBIC work
                    with its federal partners to develop a strategy to enhance collaboration—
                    including sharing data, personnel, and other resources—and to establish
                    effectiveness measures for that collaboration. DHS generally concurred
                    with our findings and recommendations and stated that NBIC would work
                    with its partners to develop a collaboration strategy to clarify both the
                    mission space and roles and responsibilities for all partners. 4 In August
                    2012, DHS issued the National Biosurveillance Integration Center
                    Strategic Plan. According to DHS officials, the plan articulates a clear
                    approach with a series of measurable steps and initiatives to enhance the
                    nation’s biosurveillance capability. In late August 2012, when providing us
                    with a copy of the strategy, officials stated that they believe it satisfies the
                    intent of our recommendations. Officials said the plan was written in
                    coordination with NBIC’s federal partners and is the result of a
                    deliberative process examining NBIC’s current capabilities and capability
                    gaps. We are currently assessing the extent to which the plan fully
                    responds to the recommendations.

                    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.
                    We reported that a national biosurveillance capability would largely rely
                    on an interagency effort because the activities and accompanying
                    resources that support the capability—personnel, training, equipment,
                    and systems—are dispersed across a number of federal agencies.



                    4
                    GAO-10-171.




                    Page 3                                                               GAO-12-994T
However, we found that the federal government did not have a unifying
framework and structure for integrating dispersed capabilities and
responsibilities and no federal agency had authority to guide and oversee
the development and implementation of a national effort that
encompassed all stakeholders with biosurveillance responsibilities. We
concluded that without such a framework and an entity with the authority,
resources, time, and responsibility for guiding its implementation, it would
be very difficult to create an integrated approach to building and
sustaining a national biosurveillance capability. We recommended that
the Homeland Security Council within the White House direct the National
Security Staff to identify, in consultation with relevant federal agencies, a
focal point to lead the development of such a strategy.

Our June 2010 report also noted that a national biosurveillance capability
depends upon participation from state, local, and tribal governments,
because few of the resources required to support the capability are wholly
owned by the federal government. In October 2011, we reported on how
the federal government worked with its nonfederal partners to support
biosurveillance, activities those partners identified as essential to their
biosurveillance efforts, and particular challenges those partners faced.
We recommended that the strategy we called for in June 2010
incorporate a means to leverage existing efforts that support nonfederal
biosurveillance capabilities, consider challenges that nonfederal
jurisdictions face, and include a framework to develop a baseline and gap
assessment of nonfederal jurisdictions’ biosurveillance capabilities. 5 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. The
strategy states that its approach emphasized teamwork between and
within federal departments, across all layers of government, and with
private sector partners. 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.




5
GAO-12-55.




Page 4                                                            GAO-12-994T
DHS Did Not Develop
Critical Knowledge
before Proceeding
with the Gen-3
Acquisition
DHS Proceeded with the     DHS approved the Gen-3 acquisition in October 2009 without fully
Gen-3 Acquisition before   developing critical knowledge that would help ensure sound investment
                           decision making, pursuit of optimal solutions, and reliable performance,
Establishing a Mission     cost, and schedule information. Specifically, DHS did not engage the
Need                       initial phase of its Acquisition Life-cycle Framework, which is designed to
                           help ensure that the mission need driving the acquisition warrants
                           investment of limited resources. 6 In the Acquisition Life Cycle Framework
                           design, it is not the purpose of the Mission Needs Statement to specify a
                           technical solution. Rather it is to serve as a touchstone for subsequent
                           acquisition efforts by focusing on the capability gap to help articulate and
                           build consensus around the goals and objectives for a program.

                           However, DHS began to pursue a specific autonomous detection solution
                           well before completing a Mission Needs Statement. Specifically, DHS’s
                           Integrated Planning Guidance (IPG) for fiscal years 2010-2014, which
                           was finalized in March 2008, included specific goals for the next
                           generation of BioWatch—to deploy in all major cities an autonomous
                           BioWatch detection device reducing the operating cost per site by more
                           than 50 percent and warning time to less than 6 hours. The purpose of
                           DHS’s IPG is to communicate the Secretary’s policy and planning goals
                           to component-level decision makers to inform their programming,
                           budgeting, and execution activities. As such, this specific set of goals for
                           BioWatch Gen-3 demonstrates that DHS leadership had established a


                           6
                            According to DHS officials, the Gen-3 acquisition was ongoing when Acquisition
                           Management Directive 102-01 was issued. The officials said that many DHS programs
                           that were ongoing in 2009 faced similar challenges. Nevertheless, DHS Management
                           Directive 1400, which preceded Acquisition Management Directive 102-01, was similarly
                           designed to, among other things, ensure that investments directly support and further
                           DHS’s missions. Like Acquisition Management Directive 102-01, Management Directive
                           1400 describes a phased lifecycle investment construct in which the first step is defining
                           the mission need in a Mission Needs Statement. As with the Mission Need Statement
                           called for in Acquisition Management Directive 102-01, the statement in Management
                           Directive 1400 was to be a high-level description of a capability gap rather than a specific
                           solution.




                           Page 5                                                                          GAO-12-994T
                         course for the acquisition by March 2008, in advance of efforts to define
                         the mission need through the Mission Needs Statement process, which
                         was finalized more than a year and a half later.

                         DHS officials in multiple departments described a climate, in the wake of
                         the September 11, 2001, terrorist attacks and the subsequent Amerithrax
                         attacks, in which the highest levels of the administration expressed
                         interest in quickly deploying the early generation BioWatch detectors and
                         improving their functionality—as quickly as possible—to allow for faster
                         detection and an indoor capability. BioWatch officials stated that they
                         were aware that the Mission Needs Statement prepared in October 2009
                         did not reflect a systematic effort to justify a capability need, but stated
                         that the department directed them to proceed because there was already
                         departmental consensus around the solution. Accordingly, the utility of the
                         Mission Needs Statement as a foundation for subsequent acquisition
                         efforts was limited.


DHS Did Not              Additionally, DHS did not use the processes established by its Acquisition
Systematically Analyze   Life-cycle Framework to systematically ensure that it was pursuing the
                         optimal solution—based on cost, benefit, and risk—to mitigate the
Alternatives             capability gap identified in the Mission Needs Statement. The DHS
                         Acquisition Life-cycle Framework calls for the program office to develop
                         an Analysis of Alternatives that systematically identifies possible
                         alternative solutions that could satisfy the identified need, considers cost-
                         benefit and risk information for each alternative, and finally selects the
                         best option from among the alternatives.

                         However, the Analysis of Alternatives prepared for the Gen-3 acquisition
                         did not reflect a systematic decision-making process. For example, in
                         addition to—or perhaps reflecting—its origin in the predetermined solution
                         from the Mission Needs Statement, the Analysis of Alternatives did not
                         fully explore costs or consider benefits and risk information as part of the
                         analysis. Instead, the Analysis of Alternatives focused on just one cost
                         metric that justified the decision to pursue autonomous detection—cost
                         per detection cycle—to the exclusion of other cost and benefit
                         considerations that might have informed decision makers. 7 Additionally,
                         the Analysis of Alternatives examined only two alternatives, though the


                         7
                          Cost per detection cycle is the cost each time an autonomous detector tests the air for
                         pathogens or the cost each time a Gen-2 filter is manually collected and tested in a
                         laboratory.




                         Page 6                                                                        GAO-12-994T
                       guidance calls for at least three. The first alternative was the currently
                       deployed Gen-2 technology with a modified operational model (which by
                       definition was unable to meet the established goals). The second
                       alternative was the complete replacement of the deployed Gen-2 program
                       with an autonomous detection technology and expanded deployment.

                       BioWatch program officials acknowledged that other options—including
                       but not limited to deploying some combination of both technologies,
                       based on risk and logistical considerations—may be more cost-effective.
                       As with the Mission Needs Statement, program officials told us that they
                       were advised that a comprehensive Analysis of Alternatives would not be
                       necessary because there was already departmental consensus that
                       autonomous detection was the optimal solution.

                       Because the Gen-3 Analysis of Alternatives did not evaluate a complete
                       solution set, did not consider complete cost information, did not consider
                       benefits, and did not include a cost-benefit analysis, it does not provide
                       information on which to base trade-off decisions. For example, it does not
                       provide information about the extent to which various aspects of the
                       solution—such as the number of participating jurisdictions—results in a
                       reduction of risk and at what cost. Given the uncertainty related to Gen-
                       3’s costs, benefits, and risk mitigation potential, DHS does not have
                       reasonable assurance that the strategy of expanding and completely
                       replacing the existing Gen-2 program with autonomous detection
                       technology is the most cost-effective solution.


DHS Did Not Fully      In October 2009, DHS approved the Gen-3 acquisition at Acquisition
Develop Performance,   Decision Event (ADE) 2A—one of the key formal decision points in DHS’s
                       Acquisition Life-cycle Framework—based on information contained in
Cost, and Schedule     acquisition documents provided by the BioWatch program. One critical
Information            purpose of the ADE-2A documentation set required by DHS’s acquisition
                       guidance is to describe the expected performance, cost, and schedule
                       parameters for an acquisition. However, the ADE-2A Acquisition Decision
                       Memorandum stated that significant data necessary for the proper
                       adjudication of an ADE-2A decision were missing. 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.

                       On the basis of the Gen-3 documentation submitted at ADE-2A, DHS
                       expected to acquire a system that would cost $2.1 billion, be fully
                       deployed by fiscal year 2016, and meet certain performance


                       Page 7                                                          GAO-12-994T
requirements. However, the performance, cost, and schedule parameters
for the Gen-3 acquisition have changed. 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. 8

BioWatch program officials told us that they had to prepare ADE-2A
documentation quickly because ADE-2A had been accelerated by more
than a year. Additionally, DHS officials from multiple offices described a
climate around the time of ADE-2A in which the department’s business
processes—including acquisition practices—were maturing and thus were
less rigorous in their adherence to best practices for cost and schedule
estimating. However, in the absence of complete and reliable information,
DHS had limited assurance that the acquisition would successfully deliver
the intended capability within cost and on schedule. Comprehensive and
systematic information developed using good practices for cost and
schedule estimating could help ensure that more reliable performance,
cost, and schedule information is available for future acquisition decision
making.

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. We are pleased that DHS plans to implement the
recommendation but are concerned by DHS’s intention to continue the
acquisition efforts before ensuring that it has fully developed the critical




8
 The $2.1 billion life-cycle cost estimate (a point estimate) submitted at ADE-2A was the
estimate used for planning purposes at the time. In the June 2011 Life-cycle Cost
Estimate, the BioWatch program recommended the 80 percent confidence level for
planning purposes. We present these estimates here in comparison because they are the
two estimates used for planning purposes. However, it is important to note that June 2011
estimates at the 28 percent and 80 percent confidence level are risk adjusted and the
2009 point estimate is not. The point estimate at the 28 percent confidence level in the
June 2011 Life-cycle Cost Estimate was $3.8 billion. The confidence level indicates the
probability that the actual cost will be at or below the estimate. For example, the June
2011 estimate of $5.8 billion conveys that (at the time of that estimate) the program
anticipated 80 percent probability that the cost would be $5.8 billion or less.




Page 8                                                                       GAO-12-994T
                            knowledge a comprehensive Acquisition Life-cycle Framework effort is
                            designed to provide.


Several Steps Remain        The BioWatch program completed initial testing and evaluation on a Gen-
before Gen-3 Is Ready for   3 prototype technology in June 2011, but several steps remain before
                            Gen-3 can be deployed and operational. 9 For example, the BioWatch
Deployment                  program must complete additional testing. The characterization testing
                            conducted in 2010 and 2011 was intended to assess the state of
                            available technology. This testing sought to demonstrate the performance
                            of available candidate Gen-3 technologies against the requirements
                            established by the BioWatch program, and consisted primarily of
                            laboratory testing of individual system components. This testing did not
                            demonstrate the performance of the full system in detecting live
                            pathogens in the operational environment. It also did not test the
                            information technology network that will transmit results for public health
                            officials. Now the program plans to conduct the next phase of testing—
                            performance testing in three independent laboratories and operational
                            test and evaluation in four BioWatch jurisdictions. On the basis of the
                            June 2011 Life-cycle Cost Estimate, the BioWatch program estimates this
                            testing will take approximately 3 years and cost approximately $89 million
                            (risk adjusted at the 80 percent confidence level).

                            The Deputy Secretary of Homeland Security and other senior officials met
                            on August 16, 2012 for an Acquisition Review Board, during which the
                            BioWatch program was seeking approval to initiate the next phase of the
                            acquisition. DHS did not make a final decision, but authorized release of a
                            solicitation for performance testing under the next testing phase. In
                            response to the recommendations we made in the Gen-3 report, DHS
                            officials stated that before awarding a performance testing contract—
                            which would allow the program to acquire a small number of test units—
                            the program office is directed to return to the Acquisition Review Board
                            for approval.




                            9
                             A second candidate technology participated in two test events—aerosol collection
                            subsystem testing and assay evaluation—but did not complete all testing because the
                            candidate system did not meet program requirements during the assay evaluation.
                            Specifically, the second candidate technology yielded both false positives—detecting a
                            BioWatch agent when none was present—and false negatives—not detecting an agent
                            when one was present.




                            Page 9                                                                      GAO-12-994T
                        Before undertaking the remaining steps in the acquisition, the program
                        office is directed to return for Acquisition Decision Event-2B (ADE-2B)—
                        the next formal decision point in DHS’s Acquisition Life-cycle
                        Framework—with updated information, including an Analysis of
                        Alternatives and Concept of Operations, as we recommended. No
                        timeframe for completing these actions has been specified, but according
                        to DHS officials, it may take up to 1 year to update the Analysis of
                        Alternatives. In preparation for the August 16, 2012, meeting, the
                        BioWatch program had updated key acquisition documents—including
                        the Life-cycle Cost Estimate and Acquisition Program Baseline—as
                        required by the Acquisition Decision Authority in a February 2012 memo.
                        However, in order to inform the ADE-2B decision, these documents must
                        accurately reflect changes to Gen-3 performance requirements and
                        updated cost and schedule estimates for the acquisition and therefore
                        may require further revisions.

                        If approved at ADE-2B, the BioWatch program plans to conduct
                        operational testing of Gen-3 units in four BioWatch jurisdictions. Following
                        operational testing, DHS intends to decide whether to authorize the
                        production and deployment of Gen-3. If Gen-3 is approved, the BioWatch
                        program plans to prepare for deployment by working with BioWatch
                        jurisdictions to develop location-specific plans to guide Gen-3 operations.
                        DHS estimates based on the June 2011 Life-cycle Cost estimate show
                        that about $5.7 billion of the $5.8 billion life-cycle cost (risk adjusted at the
                        80 percent confidence level) remains to be spent to test, produce, deploy,
                        and operate Gen-3 through fiscal year 2028.


                        In the report on Gen-3 released today, we noted that beyond the
Observations about      uncertainty related to the costs and benefits of the planned Gen-3
Prior Strategy          approach, there is additional uncertainty about the incremental benefit of
                        this kind of environmental monitoring as a risk mitigation activity because
Recommendations         of its relatively limited scope. As the study committee for a 2011 National
and the July 2012       Academies evaluation of BioWatch noted, there is considerable
                        uncertainty about the likelihood and magnitude of a biological attack, and
National Strategy for   how the risk of a release of an aerosolized pathogen compares with risks
Biosurveillance         from other potential forms of terrorism or from natural diseases. The
                        National Academies report also notes that while the BioWatch program is
                        designed to detect certain biological agents (currently five agents) that
                        could be intentionally released in aerosolized form, detecting a




                        Page 10                                                              GAO-12-994T
bioterrorism event involving other pathogens or routes of exposure
requires other approaches. 10

In the report we released today, we stated that given the total estimated
operating cost for the Gen-3 program, it is important, especially in an
increasingly resource-constrained environment, to consider the benefit—
in terms of its ability to mitigate the consequences of a potentially
catastrophic biological attack—that the investment provides. We noted
that the scope limitations of this kind of environmental monitoring provide
context in both the consideration of mission need and in analyzing cost
effectiveness. 11

However, it was not within the scope of our BioWatch Gen-3 study nor
was it our intention to reach a firm conclusion about the value of this kind
of activity as part of a layered biosurveillance strategy. 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. Therefore, we called for a
strategy that would, among other things, (1) define the scope and
purpose of a national capability; (2) provide goals, objectives and
activities, priorities, milestones, and performance measures; and (3)
assess the costs and benefits and identify resource and investment
needs, including investment priorities. 12




10
  Institute of Medicine and National Research Council of the National Academies,
Committee on Effectiveness of National Biosurveillance Systems, BioWatch and the
Public Health System, BioWatch and Public Health Surveillance: Evaluating Systems for
the Early Detection of Biological Threats (Washington, D.C.: 2011).
11
 GAO-12-810.
12
 GAO-10-645.




Page 11                                                                   GAO-12-994T
We stated that one of the aims of a national biosurveillance strategy
should be to help prioritize where resources and investments should be
targeted and guide agencies to allocate resources accordingly. Further,
we reported that a national strategy could begin to address the difficult
but critical issues of who pays and how funding for biosurveillance will be
sustained in the future. Finally, we noted that in an environment with
competing priorities, a strategy could help address situations where
investments must be carefully weighed and sound judgments made about
the most cost-effective approaches, but doing so would require
information about the cost, benefits, and risks associated with the whole
biosurveillance enterprise. 13

The National Strategy for Biosurveillance includes four guiding principles
that are designed to serve as a foundation for enterprisewide efforts, four
core functions that are designed to promote a deliberate and shared
approach, and four enabling capabilities that are designed to represent
areas for ongoing focus. 14 These planks of the strategy align with our call
for a strategy that would help to clarify the scope and purpose of a
national biosurveillance capability and the goals of that capability. Our
June 2010 report described several categories of federal efforts to
improve the personnel, training, and systems and equipment that support
a national capability. These included responding to workforce needs,
facilitating information sharing, and applying technologies to enhance
surveillance. Among the planks of the National Strategy for
Biosurveillance, it is possible to discern support for each these
categories. For example, the enabling capability called build capacity,
discusses both workforce and information sharing issues. The four
guiding principles that serve as the strategy’s foundation encourage
broad-based and cross-cutting actions to leverage constrained resources,
responding, in part, to our call for the strategy to help identify the
resources currently being used, additional resources that may be needed,
and opportunities for leveraging resources.



13
  GAO-10-645.
14
  The guiding principles articulated in the strategy are to (1) leverage existing capabilities,
(2) embrace an all-of-Nation approach, (3) add value for all participants, and (4) maintain
a global health perspective. The core functions are to (1) scan and discern the
environment, (2) identify and integrate essential information, (3) inform and alert decision
makers, and (4) forecast and advise about potential impacts. The enablers are to (1)
integrate capabilities, (2) build capacity, (3) foster innovation, and (4) strengthen
partnerships.




Page 12                                                                           GAO-12-994T
                      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. For example, in the case of the broader
                      contextual information needed to inform the BioWatch Gen-3 mission
                      need, the strategy has language indicating that advances in science and
                      technology are a priority. In fact, the capability enabler called fostering
                      innovation specifically calls for science and technology capabilities,
                      including new detection approaches. However, the strategy does not
                      facilitate analysis or provide tools to assess the risks to be addressed—in
                      the context of enterprisewide goals—by such science and technology
                      approaches or the value they should offer the enterprise relative to their
                      costs. Without such a framework and tool set, it remains difficult for
                      decision makers—in both the executive and legislative branches—to help
                      ensure that their resource allocation decisions contribute to a coherent
                      enterprisewide approach.

                      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. We are
                      hopeful that the forthcoming strategic implementation plan which
                      promises to include specific actions and activity scope, designated roles
                      and responsibilities, and a mechanism for evaluating progress will help to
                      address the ongoing need for mechanisms to help prioritize resource
                      allocation.

                      Chairmen Bilirakis and Lungren, this concludes my prepared statement. I
                      would be happy to respond to any questions you or the other committee
                      members may have.

                      For further information on this testimony, please contact Bill Jenkins,
Contact Information   (202) 512-8757 or by e-mail at jenkinswo@gao.gov. Contact points for
                      our Offices of Congressional Relations and Public Affairs may be found
                      on the last page of this statement. Other contributors include; Hal Brumm,
                      Nirmal Chaudhary, Michelle Cooper, Edward George, Kathryn Godfrey,
                      Allyson Goldstein, Tracey King, Amanda Miller, Jan Montgomery, Katy
                      Trenholme, and Katherine Trimble.




(441099)
                      Page 13                                                          GAO-12-994T
This is a work of the U.S. government and is not subject to copyright protection in the
United States. The published product may be reproduced and distributed in its entirety
without further permission from GAO. However, because this work may contain
copyrighted images or other material, permission from the copyright holder may be
necessary if you wish to reproduce this material separately.
GAO’s Mission         The Government Accountability Office, the audit, evaluation, and
                      investigative arm of Congress, exists to support Congress in meeting its
                      constitutional responsibilities and to help improve the performance and
                      accountability of the federal government for the American people. GAO
                      examines the use of public funds; evaluates federal programs and
                      policies; and provides analyses, recommendations, and other assistance
                      to help Congress make informed oversight, policy, and funding decisions.
                      GAO’s commitment to good government is reflected in its core values of
                      accountability, integrity, and reliability.

                      The fastest and easiest way to obtain copies of GAO documents at no
Obtaining Copies of   cost is through GAO’s website (http://www.gao.gov). Each weekday
GAO Reports and       afternoon, GAO posts on its website newly released reports, testimony,
                      and correspondence. To have GAO e-mail you a list of newly posted
Testimony             products, go to http://www.gao.gov and select “E-mail Updates.”

Order by Phone        The price of each GAO publication reflects GAO’s actual cost of
                      production and distribution and depends on the number of pages in the
                      publication and whether the publication is printed in color or black and
                      white. Pricing and ordering information is posted on GAO’s website,
                      http://www.gao.gov/ordering.htm.
                      Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
                      TDD (202) 512-2537.
                      Orders may be paid for using American Express, Discover Card,
                      MasterCard, Visa, check, or money order. Call for additional information.
                      Connect with GAO on Facebook, Flickr, Twitter, and YouTube.
Connect with GAO      Subscribe to our RSS Feeds or E-mail Updates. Listen to our Podcasts.
                      Visit GAO on the web at www.gao.gov.
                      Contact:
To Report Fraud,
Waste, and Abuse in   Website: http://www.gao.gov/fraudnet/fraudnet.htm
                      E-mail: fraudnet@gao.gov
Federal Programs      Automated answering system: (800) 424-5454 or (202) 512-7470

                      Katherine Siggerud, Managing Director, siggerudk@gao.gov, (202) 512-
Congressional         4400, U.S. Government Accountability Office, 441 G Street NW, Room
Relations             7125, Washington, DC 20548

                      Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800
Public Affairs        U.S. Government Accountability Office, 441 G Street NW, Room 7149
                      Washington, DC 20548




                        Please Print on Recycled Paper.