Biosurveillance: DHS Should Not Pursue BioWatch Upgrades or Enhancements Until System Capabilities Are Established
Released: 2015-11-23T00:00:00


Highlights: section_title: Why GAO Did This Study
paragraphs: DHS's BioWatch program aims to provide early indication of an aerosolized biological weapon attack. Until April 2014, DHS pursued a next-generation autonomous detection technology (Gen-3), which aimed to enable collection and analysis of air samples in less than 6 hours, unlike the current system (Gen-2), which requires manual intervention and can take up to 36 hours to detect the presence of biological pathogens. DHS is taking steps to address the capability gap that resulted from the cancellation of Gen-3 by exploring other technology upgrades and improvements to the Gen-2 system.

GAO was asked to review (1) the technical capabilities of the currently deployed BioWatch system, (2) the Gen-3 testing effort, and (3) characteristics of autonomous detection as a possible option to replace the current BioWatch system. GAO analyzed key program documents, including test plans, test results, and modeling studies. GAO assessed Gen-3 testing against best practices, reviewed relevant literature, and discussed the BioWatch program and testing efforts with key agency officials and national laboratories staff.

section_title: What GAO Found
paragraphs: The Department of Homeland Security (DHS) lacks reliable information about BioWatch Gen-2's technical capabilities to detect a biological attack and therefore lacks the basis for informed cost-benefit decisions about upgrades to the system. DHS commissioned several tests of the technical performance characteristics of the current BioWatch Gen-2 system, but has not developed performance requirements that would enable it to interpret the test results and draw conclusions about the system's ability to detect attacks. Although DHS officials said that the system can detect catastrophic attacks, which they define as attacks large enough to cause 10,000 casualties, they have not specified the performance requirements necessary to reliably meet this operational objective. In the absence of performance requirements, DHS officials said computer modeling and simulation studies support their assertion. However, none of these studies were designed to incorporate test results from the Gen-2 system and comprehensively assess the system against the stated operational objective. Additionally, DHS has not prepared an analysis that combines the modeling and simulation studies with the specific Gen-2 test results to assess the system's capabilities to detect attacks. Finally, we found limitations and uncertainties in the four key tests of the Gen-2 system's performance. Because it is not possible to test the BioWatch system directly by releasing live biothreat agents into the air in operational environments, DHS relied on chamber testing and the use of simulated biothreat agents, which limit the applicability of the results. These limitations underscore the need for a full accounting of statistical and other uncertainties, without which decision makers lack a full understanding of the Gen-2 system's capability to detect attacks of defined types and sizes and cannot make informed decisions about the value of proposed upgrades.

The actions and decisions DHS made regarding the acquisition and testing of a proposed next generation of BioWatch (Gen-3) partially aligned with best practices GAO previously identified for developmental testing of threat detection systems. For example, best practices indicate that resilience testing, or testing for vulnerabilities, can help uncover problems early. While DHS took steps to help build resilience into the Gen-3 testing, future testing could be improved by using more rigorous methods to help predict performance in different operational environments. DHS canceled the Gen-3 acquisition in April 2014, but GAO identified lessons DHS could learn by applying these best practices to the proposed Gen-2 upgrades.

According to experts and practitioners, the polymerase chain reaction (PCR), which detects genetic signatures of biothreat agents, is the most mature technology to use for an autonomous detection system. DHS is considering autonomous detection as an upgrade to Gen-2, because according to DHS, it may provide benefits such as reduction in casualties or clean-up costs. But the extent of these benefits is uncertain because of several assumptions, such as the speed of response after a detection, that are largely outside of DHS's control. As a result, the effectiveness of the responseâ€”and the number of lives that could be savedâ€”is uncertain. Further, an autonomous detection system must address several likely challenges, including minimizing possible false positive readings, meeting sensitivity requirements, and securing information technology networks.

section_title: What GAO Recommends
paragraphs: GAO recommends DHS not pursue upgrades or enhancements for Gen-2 until it reliably establishes the system's current capabilities. GAO also recommends DHS incorporate best practices for testing in conducting any system upgrades. DHS generally concurred with GAO's recommendations.

or Chris Currie at (404) 679-1875 or curriec@gao.gov .

section_title: Letter
paragraphs: The 2001 anthrax attack—in which 22 individuals contracted anthrax, 5 of  whom died, from exposure to anthrax spores sent through the mail— brought new awareness of the threat posed by bioterrorism. Given the  relative speed and intensity with which a biological weapon of mass  destruction could affect the nation, experts and practitioners have sought  to augment traditional surveillance activities with biosurveillance  programs and systems to achieve early detection and warning. The  Department of Homeland Security’s (DHS) BioWatch program, begun in  2003, was designed to provide early indication of an aerosolized  biological weapon attack. Overseen by DHS’s Office of Health Affairs  (OHA), the BioWatch program involves a system of aerosol collectors  deployed in more than 30 cities, as well as laboratory facilities and  personnel to analyze samples from these collectors. The program aims to  reduce the time required to recognize and characterize potentially  catastrophic aerosolized attacks by monitoring for the presence of certain  biological agents considered to pose high risk for an aerosolized attack.

The currently deployed BioWatch system, known as Generation-2 (Gen- 2), operated on an annual budget of nearly $87 million in fiscal year 2015.  Gen-2 is designed to detect the presence of biothreat agents in 12 to 36  hours. The National Academies questioned Gen-2’s technical capability in  2011, including its ability to detect attacks and the reliability of results that  indicate a possible attack. Although Gen-2 has been used in the field for  over a decade, the National Academies stated in 2011 that the rapid  initial deployment of BioWatch did not allow for sufficient testing,  validation, and evaluation of the system and its components.

Questions have also been raised about testing conducted during the  evaluation of a next-generation technology for BioWatch, known as  Generation-3 (Gen-3) Phase I testing. The goal of the Gen-3 effort was  an autonomous system, that is, a single device that would collect airborne  particles, analyze them, and communicate the results to decision makers  automatically. Such a device, known as a lab-in-a-box, would contrast  with the current BioWatch system, in which samples are retrieved  manually and transported to laboratories for analysis. The new  technology aimed to reduce detection time, potentially generating a result  in under 6 hours, and to eliminate certain labor costs. The Gen-3  acquisition was canceled in April 2014, after testing difficulties and after  an analysis of alternatives was interpreted by DHS as showing any  advantages of an autonomous system over the current manual system  were insufficient to justify the cost of a full technology switch. Our prior  work has shown that BioWatch Gen-3 was among other DHS acquisitions  that, in an effort to deploy quickly, faced challenges because of testing  performance.

Having canceled the Gen-3 acquisition, DHS continues to rely on the  Gen-2 system for early detection of an aerosolized biological attack.  Some Gen-2 equipment will reach the end of its life cycle in the next year,  and DHS will need to make decisions about reinvesting in the program.  Further, OHA and DHS’s Science and Technology Directorate (S&T) are  collaborating on next steps for the BioWatch program in an attempt to  address the capability gap that Gen-3 was intended to fill, as well as other  technology upgrades and improvements to the Gen-2 system. Cost- benefit decisions about future investment in BioWatch will require reliable  information about Gen-2’s current capabilities. More broadly, as the  National Academies noted in 2011, stakeholders in the biosurveillance  enterprise must consider not only the extent to which early detection can  make a difference given the challenges of effective response and medical  countermeasures, but also the trade-offs of allocating funding across the  range of biosurveillance activities. In this context, you asked us to review  technical aspects of the BioWatch program. This report addresses the  following questions:  1.  To what extent has DHS assessed the technical capability of the  currently deployed system (Gen-2) to detect a biological attack, which  is necessary to inform decisions about upgrades and enhancements?  2.  To what extent did DHS adhere to best practices for developmental  testing during Gen-3 Phase I, and what lessons can be learned as  DHS considers upgrades to Gen-2?  3.  Which technology is currently most mature for an autonomous  detection system as a possible upgrade from Gen-2, and what would  the potential benefits and likely challenges be if DHS were to pursue  an autonomous detection system in the near future?

To determine the extent to which DHS has assessed the technical  capability of the Gen-2 system to detect an attack, we reviewed and  analyzed test reports and other agency and agency-commissioned  documents containing information on the design, development,  deployment, and technical performance characteristics of the system. We  also reviewed reports of modeling and simulation, conducted by  Department of Energy (DOE) national laboratories for DHS, that analyzed  the performance and capabilities of the system. To assess the strengths  and limitations of tests and studies of the Gen-2 system, we used (1) a  framework for testing and evaluation of biodetection systems developed  by the National Research Council; (2) leading practices in risk analysis  and cost-benefit analysis; and (3) judgment of internal and external  experts in the fields of engineering, aerobiology, microbiology, and testing  and evaluation of biodetection systems.

To determine whether DHS’s actions during Gen-3 Phase I adhered to  best practices for developmental testing and to identify lessons that could  be learned, we reviewed the best practices previously developed in  conjunction with the National Academies to assess their appropriateness  to our review. We analyzed Gen-3 Phase I acquisition and testing  documents, such as the test and evaluation master plans, individual test  plans and results, and the operational requirements documents (which lay  out the minimum acceptable operational performance requirements). We  analyzed other DHS documentation on lessons learned, including the  Post Implementation Review assessment in which DHS identified its own  lessons learned on the Gen-3 acquisition. We reviewed the acquisition  decision memorandum (ADM) on the cancellation of the Gen-3  acquisition. We also compared the steps outlined in the test planning  documents with the recommended steps described in the best practices.  We consulted with internal and external experts on our evaluation of  DHS’s actions and decisions against the best practices. We reviewed  prior GAO reports on the Gen-3 acquisition and the biosurveillance  enterprise. We also reviewed prior GAO work on other DHS acquisitions  that met challenges during early phases of testing to draw comparisons  with other DHS acquisitions that may have benefited from more robust  testing guidance.

To identify the most mature technology for autonomous detection, we  reviewed a report of a 2013 workshop conducted by the National  Academies that assessed the state of technologies that are potentially  suitable for autonomous detection for the BioWatch program. We also  performed a literature review of journals and conference proceedings  published since 2012. Our literature review was not intended to be a  comprehensive examination of all technologies that might possibly be  applied to BioWatch, but rather a supplement to the National Academies  workshop report and a check to help ensure that the conclusions of that  workshop were not affected by more recent developments in the field. To  assess the potential benefits and likely challenges of autonomous  detection, we analyzed reports published by the Sandia National  Laboratories, as well as our prior work on the Gen-3 BioWatch system.  We performed a literature review for the past 12 years on models of how  response timing to a positive detection of agent release may affect  response effectiveness, in terms of lives saved. We interviewed officials  at the Centers for Disease Control and Prevention (CDC), at DHS’s Office  of Health Affairs, and at Lawrence Livermore National Laboratory (LLNL)  who were familiar with BioWatch and biodetection technologies. We  asked for their views on the state of autonomous detection technology  and the potential benefits and likely challenges of autonomous detection  in the next 5 years.

For additional insight and contextual sophistication supporting our  analysis across all research objectives, we interviewed DHS officials from  the BioWatch Program Office and S&T who had knowledge of the history  of the BioWatch program, the Gen-2 and Gen-3 technologies and  changes that had been made to the Gen-2 technology over time, and the  tests and studies that had been conducted on the Gen-2 and Gen-3  systems’ technical capabilities. We also collected information from these  officials on DHS’s actions and decisions during Phase I testing and  compared that with the recommended actions outlined in the best  practices for developmental testing. We interviewed officials at the DOE  national laboratories who conducted or were familiar with the BioWatch  testing and the modeling and simulation studies, and we interviewed  officials at Department of Defense (DOD) test agencies who were familiar  with the Gen-2 and Gen-3 testing. To help collect and analyze  information, and to help ensure the technical accuracy of our work, we  consulted with subject matter experts under contract with GAO in the  fields of aerobiology, microbiology, and biodetection. A more detailed  discussion of our methodology appears in appendix I.

We conducted this performance audit from December 2013 to October  2015 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.
subsections: section_title: Background
subsections: section_title: How the BioWatch Program Works
paragraphs: Currently, the BioWatch program collaborates with more than 30  BioWatch jurisdictions throughout the nation to operate approximately  600 Gen-2 aerosol collectors. These units rely on a vacuum-based  collection system that draws air through a filter. These filters are manually  collected and transported to state and local public health laboratories for  analysis using a process called polymerase chain reaction (PCR).  Sometimes also called molecular photocopying, PCR is a technique used  to amplify (or copy) segments of deoxyribonucleic acid (DNA), the  building blocks of genetic material. By targeting specific segments of  genetic material, PCR can be used as the basis for a test, or assay, for  the presence of genetic signatures associated with specific biological  organisms, such as the five BioWatch threat agents. (The program  monitors for six distinct biothreat agents, but two of these are closely  related, although they cause different diseases, and the BioWatch  program has treated them as a single agent. For consistency, we will treat  them as a single agent and report that there are five BioWatch threat  agents in total.) In the BioWatch Gen-2 system, multiple PCR assays are  used for each threat agent. In an initial “screening” step, one assay is run  for each threat agent. If any of these assays yields a positive result,  suggesting the presence of one of the threat agents, then the analysis  proceeds to a “verification” step in which multiple additional assays are  run targeting different genetic signatures for that agent. If the verification  step also yields a positive result, then a BioWatch Actionable Result  (BAR) is declared. Using this manual process, the determination of a  BAR can occur from 12 to 36 hours after an agent is initially captured by  the aerosol collection unit. This 36-hour timeline consists of up to 24  hours for air sampling, up to 4 hours for retrieving the sample from an  aerosol collection unit and transporting it to the laboratory, and up to 8  hours for laboratory testing.

Each BioWatch jurisdiction has either a BioWatch Advisory Committee or  equivalent decision-making group in place, composed of public health  officials, first responders, and other relevant stakeholders. The BioWatch  Advisory Committee is responsible for the day-to-day BioWatch  operations, including routine filter collection and laboratory analysis of  filter samples. In the event of a BAR, the BioWatch Advisory Committee,  in partnership with OHA and other stakeholders, is also responsible for  determining whether that BAR poses a public health risk and deciding  how to respond. The declaration of a BAR does not necessarily signal  that a biological attack has occurred. BARs have been triggered by  biological agents that occur naturally in numerous areas of the United  States. From 2003 through 2014, 149 BARs were declared, but none was  linked to an attack or to a public health threat. For a more detailed  discussion of this issue, see appendix II. Figure 1 shows the process that  local BioWatch jurisdictions are to follow when deciding how to respond to  a BAR.

section_title: A History of BioWatch
paragraphs: In cooperation with other federal agencies, DHS created the BioWatch  program in 2003. The goal of BioWatch is to provide early warning,  detection, or recognition of a biological attack. When DHS was  established in 2002, a perceived urgency to deploy useful—even if  immature—technologies in the face of potentially catastrophic  consequences catalyzed the rapid deployment of many technologies. In  the initial deployment of BioWatch—known as Generation-1—DHS  deployed aerosol collectors to 20 major metropolitan areas, known as  BioWatch jurisdictions, to monitor primarily outdoor spaces. DHS  completed the initial deployment quickly—within 80 days of the  President’s announcement of the BioWatch program in his 2003 State of  the Union Address. To accomplish this rapid deployment, DHS adapted  an existing technology that was already used for other air monitoring  missions. In 2005, DHS expanded BioWatch to an additional 10  jurisdictions, for a total of more than 30. The expanded deployment— referred to as Gen-2—also included the addition of indoor monitoring  capabilities in three high-threat jurisdictions and provided additional  capacity for events of national significance, such as major sporting events  and political conventions. The technology used in Gen-1 and Gen-2 was  deployed rapidly and, according to the National Academies in 2011,  without sufficient testing, validation, and evaluation of its technical  capabilities.

To reduce the time required to detect biothreat agents, DHS began to  develop autonomous detection capability in 2003 for the BioWatch  program—known as Gen-3. Envisioned as a laboratory-in-a-box, the  autonomous detection system would automatically collect air samples,  conduct analysis to detect the presence of biothreat agents every 4 to 6  hours, and communicate the results to public health officials via an  electronic network without manual intervention. By automating the  analysis, DHS anticipated that detection time could be reduced to 6 hours  or less, making the technology more appropriate for monitoring indoor  high-occupancy facilities such as transportation nodes and enabling a  more rapid response to an attack. DHS also anticipated a reduction in  operational costs by eliminating the program’s daily manual sample  retrieval and laboratory analysis. In 2008, DHS OHA initiated a  competitive bid process for the first testing phase of the Gen-3  acquisition, known as Gen-3 Phase I. Five vendors responded to the  request for proposal, and DHS awarded contracts to two, for technologies  known as the Bioagent Autonomous Network Detector (BAND, later  named M-BAND) and the Next Gen Automated Detection System (NG- ADS).

From May 2010 through June 2011, the BioWatch program conducted  Phase I testing on these candidate Gen-3 technologies. The testing  goals included characterizing the state of available autonomous detection  technology on the market and evaluating the candidate systems’ abilities  to meet performance requirements developed by the BioWatch program.  The Phase I testing consisted of testing of individual system components,  such as the aerosol sampling component (the component that collects  particles from the air) and the analytical subsystem (the component that  detects and identifies biothreat agents), whole system chamber testing,  and an operational field test in a BioWatch jurisdiction. Characterization  testing did not demonstrate the system’s end-to-end ability to detect the  five BioWatch threat agents in an operational environment because these  agents cannot be released into the air in such environments.

Expressing concern in 2011 about the rigor of DHS’s effort to help guide  its Gen-3 decision making, Members of the Congress asked us to  examine issues related to the Gen-3 acquisition. We released a report  that evaluated the acquisition decision-making process for Gen-3 in  September 2012. We recommended that before continuing the Gen-3  acquisition, DHS should carry out key acquisition steps, including  reevaluating the mission need and systematically analyzing alternatives  based on cost-benefit and risk information. DHS subsequently  commissioned an analysis of alternatives, which was interpreted by DHS  as showing that any advantages of an autonomous system over the  current manual system were insufficient to justify the cost of a full  technology switch. DHS’s April 24, 2014, ADM announced the  cancellation of the Gen-3 acquisition and made Gen-2 the official program  of record for aerosol biological threat detection. The ADM also directed  S&T to explore development and maturation of an effective and  affordable automated aerosol biodetection capability, or other operational  enhancements, that meets the operational requirements of the BioWatch  system.

section_title: Methods and Measures for Assessing System Performance
paragraphs: The capabilities of the BioWatch system can be assessed at three  different levels (fig. 2). At the highest level, BioWatch consists of an array  of aerosol collectors deployed in an operational environment and the  associated laboratory processes for analyzing samples. The operational  environment might be outdoors, as in a metropolitan area (shown in the  fig.); indoors, as in an airport; or a subway or other transit system. At this  level, the capability of the system to detect an attack depends on factors  that include the performance characteristics of the technology (including  the aerosol collector and the technology used for laboratory analysis of  samples), the number and locations of the collectors, the location of an  attack (that is, where a biothreat agent is released into the air), and wind  patterns (for an outdoor attack).

At the next level is the detector, which consists of the aerosol collector  unit and the process by which samples collected by this unit are  transferred to a laboratory and analyzed. Performance and  effectiveness at this level depend on the technical performance  characteristics of the aerosol collector itself, the extent to which the  sample is preserved intact during the collection cycle and during transport  to the laboratory, and the laboratory processes that are used to prepare  and analyze the sample.

Finally, performance can also be assessed at the level of individual  components of the detector. These include (1) the aerosol collection unit,  which collects and retains aerosol particles on a filter; (2) the sample  recovery process, by which samples are removed from the aerosol  collector and transported to a laboratory; (3) the filter extraction process,  in which aerosol particles are removed from the filter and put into a liquid  solution; (4) the DNA extraction process, in which DNA is extracted from  the aerosol particles in liquid solution in preparation for further analysis;  and (5) the PCR assays, which are used to test for the presence of  specific genetic signatures of biothreat agents (as described earlier).

At the highest level—an array of detectors deployed in an operational  environment—measures of performance include the system’s probability  of detection (Pd) for attacks of different types and sizes. The BioWatch  program employs a variation on the Pd measure that is designed to  assess the system’s ability to detect attacks that could cause large  numbers of casualties. Because BioWatch threat agents cannot be  released into the air in operational environments, the performance of an  array of detectors cannot be tested directly. One method of testing that  can be used to address this limitation is the use of simulants for biothreat  agents. A simulant is a selected nonpathogenic organism that mimics all  or some of the physical or biological characteristics of one or more  pathogenic agents. Another method that has been used for BioWatch  involves computer modeling and simulation of attack scenarios.

At the level of a single detector, key measures of system performance  include limits of detection, probability of detection, and specificity. The  limits of detection are the lowest aerosol concentrations at which the  system can detect the presence of a biothreat agent with a defined level  of reliability. Probability of detection is the likelihood that the system will  correctly detect the presence of a biothreat agent when it is present at a  given aerosol concentration in the immediate vicinity of the detector.  Specificity is the probability that the system will correctly yield a negative  result when a biothreat agent is not present (that is, the probability that  the system will not generate a “false positive”). The term specificity may  also refer to the system’s ability to distinguish a biothreat agent from  other, similar organisms.

At this single detector level, limits of detection and probability of detection  reflect the sensitivity of the system and help determine the ability of an  array of detectors in an operational environment to detect attacks; all else  being equal, a more sensitive system will have greater ability to detect  attacks. (Note, however, that the sensitivity of a single detector reflects its  ability to detect an aerosol at the location where the detector is placed;  additional analysis must be done to say what this means for the ability of  an array of detectors in different locations to detect attacks of defined  types and sizes.) The specificity of the system may contribute to the  confidence that stakeholders and decision makers have in a positive  result; a system with higher specificity is less likely to generate false  positives, so users can have greater confidence in a positive result.

Detector-level performance is assessed primarily through testing. Such  tests may be conducted in laboratory chambers or in open air and may  involve live biothreat agents or simulants. End-to-end tests using live  agents are currently not possible for the BioWatch system, as the  BioWatch threat agents cannot be released in open-air environments, and  at present there is no indoor chamber in which testing the Gen-2 system  with live agents is technically feasible. Consequently, end-to-end tests  of BioWatch must rely on simulants, which may be inactivated, or killed,  forms of the same agents that the system is designed to detect.  Alternatively, simulants may be related organisms, either live or killed.  Testing a biodetection system outdoors with killed related organisms  presents the most realistic opportunity to evaluate performance in an  operationally representative environment.

Individual components of a detection system, such as the aerosol  collector or the assay component, may be tested under strictly defined  conditions. This type of testing could support comparisons of components  with live agents and simulants and provides for a tight control of test  conditions and variables for a robust characterization of components.  However, testing components in a laboratory or chamber setting typically  excludes some factors that might affect system performance in an  operational environment, such as meteorological factors and materials in  the air that might interfere with system performance (called interferents).  Important meteorological factors include relative humidity, temperature,  and solar irradiance; important interferents include pollutants (e.g.,  nitrates or carbon monoxide), as well as smoke and dust, all of which can  influence the performance of a biodetection system. Also, the operational  environment is difficult to reproduce in a biological containment chamber  in terms of the aerosol concentration, particle size distribution, aging of  the agent, and dispersion dynamics. The metrics used for components of  a system depend on the component being tested. For example, for an  aerosol collection component, they might include efficiency (i.e., the  percentage of aerosol particles successfully collected on the filter and  retained intact for subsequent analysis). For laboratory tests or assays,  other metrics are used, including sensitivity, limits of detection, and  specificity, as well as the efficiency of the processes by which samples  are removed from the filter and prepared for analysis.

section_title: Biodefense, BioWatch, and the Biosurveillance Enterprise
paragraphs: Concerned with the threat of bioterrorism, in 2004, the White House  released Homeland Security Presidential Directive 10 (HSPD-10), which  outlined four pillars of the biodefense enterprise and discussed various  federal efforts and responsibilities to help support it. The biodefense  enterprise is the whole combination of systems at every level of  government and the private sector that can contribute to protecting the  nation and its citizens from potentially catastrophic effects of a biological  event. It is composed of a complex collection of federal, state, local, tribal,  territorial, and private resources, programs, and initiatives, designed for  different purposes and dedicated to mitigating various risks, both natural  and intentional. The four pillars of biodefense outlined in HSPD-10 were  (1) threat awareness, (2) prevention and protection, (3) surveillance and  detection, and (4) response and recovery. The BioWatch program falls  under the surveillance and detection pillar, as an example of an  environmental monitoring activity. Biosurveillance also includes disease  monitoring and reporting to protect humans, animals, and plants from  potentially catastrophic effects of intentional or natural biological events.

However, in 2011, the National Academies evaluation of BioWatch noted  considerable uncertainty about the likelihood and magnitude of a  biological attack, and about how the risk of a release of an aerosolized  pathogen compares with risks from other potential forms of terrorism or  from natural diseases. BioWatch was deployed rapidly to meet a  perceived need for a system to detect catastrophic attacks. More recently,  as we reported in 2012, OHA officials told us they use the Bioterrorism  Risk Assessment (BTRA) to inform BioWatch because it is the most  relevant risk assessment available to them and because it allows OHA to  focus BioWatch detection efforts on the biological agents of significant  concern. However, in 2008, the National Academies raised concerns  about the methods used to develop the BTRA, particularly the methods  used to assess the probability of an attack. The last full BTRA was  issued in 2010 and did not address all the recommendations made by the  National Academies.

The National Academies’ evaluation of BioWatch in 2011 also stated that  to achieve its health protection goals, the BioWatch system should be  better linked to a broader and more effective national biosurveillance  framework that will help provide state and local public health authorities,  in collaboration with the health care system, with the information they  need to determine the appropriate response to a possible or confirmed  attack or disease outbreak. In our earlier work, we highlighted the  uncertainty about the incremental risk-mitigating benefit of the kind of  environmental monitoring offered by BioWatch because of its relatively  limited scope and the challenges agencies face in making investment  decisions. In our June 2010 report on federal biosurveillance efforts, we  recommended the Homeland Security Council direct the National Security  Staff to identify a focal point to lead the development of a national  biosurveillance strategy. We made this recommendation because 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. In July 2012, the White House  released the National Strategy for Biosurveillance to describe the U.S.  government’s approach to strengthening biosurveillance, but it did not  fully meet the intent of our prior recommendations, because it did not offer  a mechanism to identify resource and investment needs, including  investment priorities among various biosurveillance efforts. Further, in  2005, we reported that because the nation cannot afford to protect  everything against all threats, choices must be made about protection  priorities given the risk and how to best allocate available resources.  The strategic implementation plan has not been publicly released, but  according to the strategy, it will include specific actions and activity scope,  designated roles and responsibilities, and a mechanism for evaluating  progress. However, it is too soon to tell what effect, if any, it may have on  determining resource allocation priorities across the agencies.

section_title: DHS Cannot Make Informed Decisions about Upgrades or Enhancements Because It Lacks Reliable Information about Gen-2’s Capability to Detect an Attack
paragraphs: DHS lacks reliable information about BioWatch Gen-2’s technical  capabilities to detect a biological attack and therefore lacks the basis for  informed cost-benefit decisions about possible upgrades or  enhancements to the system. In order to assess Gen-2’s capability to  detect a biological attack, DHS would have to link test results to its  conclusions about the ability of arrays of deployed detectors to detect  attacks in BioWatch operational environments. This would ordinarily be  done by developing and validating technical performance requirements  based on operational objectives, but DHS has not developed such  requirements for Gen-2. In the absence of technical performance  requirements, DHS officials said their assertion that the system can  detect catastrophic attacks is supported by modeling and simulation  studies. However, these studies have not directly and comprehensively  assessed the capabilities of the Gen-2 system. Furthermore, in our review  of the tests that have been conducted, we found there are limitations and  uncertainties in the test results on the technical performance  characteristics of the Gen-2 system.
subsections: section_title: DHS Has Not Developed Performance Requirements That Would Allow Conclusions about Gen-2’s Ability to Detect Attacks
paragraphs: DHS commissioned four key tests of Gen-2’s technical performance  characteristics, but has not developed and validated performance  requirements that would enable it to interpret the test results and draw  conclusions about the ability of an array of detectors in an operational  environment to detect attacks. One test focused on the sensitivity of the  whole system (that is, the aerosol collection unit and subsequent  laboratory analysis of samples collected by that unit), while others  focused on components of the system (table 1). None of these four tests  focused on the highest level that we identified earlier—that is, an array of  detectors placed in different locations. The four tests are described briefly  below.

Dugway Proving Ground conducted a test of the sensitivity of the  whole system, from the unit that collects aerosol particles on a filter  through the analysis that looks for genetic material from biothreat  agents. This test was designed to assess the system’s ability to detect  aerosols of different concentrations, and it produced estimates of the  system’s limits of detection (that is, the lowest aerosol concentrations  that the system could detect with defined levels of reliability).

Dugway also conducted a test of the efficiencies of particular  components of the Gen-2 system—in particular, the filter wash  component (where aerosol particles are recovered from the filter into  a liquid solution) and the DNA extraction component (where genetic  material is extracted from the aerosol particles for further analysis).  Each of these components influences the overall sensitivity of the  Gen-2 system.

Edgewood Chemical Biological Center conducted a test of the aerosol  collection component of the system by aerosolizing particles and  measuring the system’s efficiency at trapping these particles on the  filter and transferring them into liquid solution, another component  whose performance influences the overall sensitivity of the system.

Los Alamos National Laboratory conducted tests of the PCR assays,  which included measuring the assays’ sensitivity (their ability to detect  different amounts of genetic material from the BioWatch threat  agents), as well as their specificity (their ability to detect various  strains of the BioWatch threat agents while correctly “ignoring” genetic  material from other agents and interfering substances and materials  commonly found in the environment).

In addition to these four key tests, DHS commissioned a demonstration of  the system in an outdoor environment and conducts quality assurance  tests on an ongoing basis. Both of these provide additional information  about the system’s capabilities; however, we do not include them in our  list of key tests because neither was designed to produce estimates of  key performance characteristics, including sensitivity, or to support  conclusions about the types and sizes of attack the system can reliably  detect. The outdoor demonstration, performed by the Naval Surface  Warfare Center Dahlgren Division, involved releasing a simulant for one  of the BioWatch threat agents and showed that the Gen-2 technology  could successfully detect this simulant in an open-air environment.  However, aerosol concentrations were not varied systematically and  measured independently in such a way as to produce statistical estimates  of the system’s sensitivity. Additionally, ongoing quality assurance tests of  the laboratory component of the Gen-2 system include testing filters that  (1) contain potential interferents from BioWatch operational environments  and (2) have been “spiked” with samples of killed biothreat agents, to  verify that the system correctly detects these agents. However, these  tests challenge the system with just one concentration of agent on the  filter and therefore do not involve the systematic variation in concentration  that is required to produce statistical estimates of the system’s sensitivity.  Rather than estimating the system’s performance characteristics, these  quality assurance tests are designed to provide confidence that system  performance meets or exceeds benchmarks based on past system  performance.

Under both DHS guidance and standard practice in testing and evaluation  of defense systems, test results would be compared with predefined  technical performance requirements. Those requirements would specify  the technical performance parameters that a system must achieve in  order to meet its operational objectives. In other words, requirements  would provide targets against which test results can be evaluated in order  to assess whether the system will reliably achieve its intended purpose.  Technical performance requirements for BioWatch could include the limits  of detection and probability of detection that a detector needs in order for  a deployed array of detectors to reliably detect attacks of particular types  and sizes.

While DHS has commissioned some testing of the system’s performance  characteristics, officials told us they have not developed technical  performance requirements, which would enable them to interpret the test  results and draw conclusions about the system’s ability to meet its  operational objective. DHS officials told us that the system’s operational  objective is to detect catastrophic attacks, which they define as attacks  large enough to cause 10,000 casualties, and they stated that the system  is able to meet this objective. However, as we have previously reported,  the BioWatch system was deployed quickly in 2003 to address a  perceived urgent need; it was deployed without performance  requirements and, as the National Academies has reported, without  sufficient testing. In keeping with Office of Management and Budget  (OMB) guidance on making decisions about federal programs, decisions  about upgrades for BioWatch will require comprehensive information  about the benefits and costs associated with the current system, including  its capability to meet its operational objective. However, DHS officials  told us that in the 12 years since BioWatch’s initial deployment, they have  not developed technical performance requirements against which to  measure the system’s ability to meet its objective. Nevertheless, DHS has  already taken steps to pursue enhancements to the Gen-2 system.  Because DHS lacks targets for the current system’s performance  characteristics, including limits of detection, that would enable  conclusions about the system’s ability to detect attacks of defined types  and sizes with specified probabilities, it also cannot ensure it has  complete information to make decisions about upgrades or  enhancements.

section_title: DHS-Commissioned Modeling and Simulation Studies Have Not Directly and Comprehensively Assessed Gen-2 Capabilities
paragraphs: In the absence of technical performance requirements for Gen-2, DHS  officials said they have used modeling and simulation studies,  commissioned from multiple national laboratories, to link test results to  conclusions about the system’s ability to detect attacks. In particular, they  said that these modeling and simulation studies support their assertion  that the Gen-2 system can detect catastrophic attacks, defined as attacks  large enough to cause 10,000 casualties. However, while DHS officials  provided reports to illustrate the modeling and simulation work that has  been done, none of the studies that were provided or described to us  incorporated specific test results, accounted for uncertainties in those  results, and drew specific conclusions about the Gen-2 system’s ability to  achieve the defined operational objective. Further, according to officials,  DHS has not prepared an analysis of its own that combines the modeling  and simulation studies with the specific Gen-2 test results to demonstrate  DHS’s assertions about the system’s capabilities to detect attacks of  defined types and sizes.

The modeling and simulation studies were designed for purposes other  than to directly and comprehensively assess Gen-2’s operational  capabilities. For example, one set of modeling and simulation studies,  conducted by Sandia National Laboratories (Sandia) in collaboration with  other national laboratories, was designed to predict the capabilities of  hypothetical biodetection systems (similar to BioWatch) with different  performance characteristics and deployed in different ways. For instance,  these studies, which Sandia researchers called trade-space studies,  assessed possible trade-offs in deploying fewer detectors with higher  sensitivity or deploying more detectors with lower sensitivity. Sandia  constructed models of hypothetical biodetection systems and then  analyzed how these hypothetical systems would respond to simulated  attacks of different sizes, using different agents, in different locations, and  under different conditions (e.g., outdoor attacks with different wind speeds  and directions, which affect how an aerosol disperses over an area).  Because the goal was to assess hypothetical biodetection systems,  Sandia analyzed ranges of hypothetical system sensitivities rather than  incorporating the results of the four key tests of the performance  characteristics of Gen-2. These studies drew no conclusions about the  actual capabilities of the deployed Gen-2 system.

Further, the trade-space studies did not incorporate information about the  actual locations of Gen-2 collector units. Rather, these studies were  designed to model hypothetical BioWatch deployments in which collectors  were placed in optimal locations. If the Gen-2 collectors were not actually  placed in these optimal locations, then model results might not accurately  describe the capabilities of the system as currently deployed.

In addition to the trade-space studies, DHS officials described modeling  and simulation work they commissioned for the purpose of selecting sites  for Gen-2 collector units; however, this work also had limitations that  prevent specific conclusions about the Gen-2 system’s operational  capabilities. Unlike the trade-space studies, the collector-siting analyses  do include a test result that is meant to describe the sensitivity of the  Gen-2 system. However, the test result used in this work was for just one  of the five BioWatch threat agents, as decisions about collector siting are  based on just this one agent. Consequently, these collector-siting  analyses contain no information about the system’s capabilities to detect  attacks using any of the other four BioWatch threat agents. Further, the  test result used in this work was not from the four key tests of Gen-2  described earlier, but from an older test from 2004. An internal DHS  analysis in 2013 noted that there were differences between the system  tested in 2004 and the currently deployed system that limit the ability to  draw conclusions from the 2004 results. Finally, the collector-siting  studies use a measure of operational capability that does not directly  support conclusions about the BioWatch objective of detecting attacks  large enough to cause 10,000 casualties. In general, these studies use a  measure called fraction of population protected, or Fp. Roughly speaking,  Fp represents a system’s probability of successfully detecting simulated  attacks, but calculated in a way that gives more weight to attacks that  infect more people and less weight to attacks that infect fewer people. We  believe this metric does not directly support conclusions about the  system’s ability to detect attacks causing more than 10,000 casualties.  Such conclusions would be supported by another metric that has been  used by Sandia but is not preferred by the BioWatch program: the  probability of detection (Pd) for attacks causing more than 10,000  casualties. DHS officials told us that they use Fp because BioWatch has  a public health mission and so the system should be assessed in a way  that reflects its ability to detect attacks that infect more people. However,  Pd for attacks causing more than 10,000 casualties also incorporates  public health impact; unlike Fp, it could directly support conclusions about  the BioWatch operational objective, and, as noted in a Sandia report, is  straightforward to communicate. Sandia officials told us that Fp has  certain strengths and is appropriate for certain purposes. However,  because the collector-siting studies focus on Fp, their results are not  straightforward to communicate and do not support conclusions that align  directly with the BioWatch operational objective.

Finally, because none of the modeling and simulation work was designed  to interpret Gen-2 test results and comprehensively assess the  capabilities of the Gen-2 system, none of these studies has provided a full  accounting of statistical and other uncertainties—meaning decision  makers have no means of understanding the precision or confidence in  what is known about system capabilities. Best practices in risk analysis  and cost-benefit analysis require an explicit accounting of uncertainties so  that decision makers can grasp the reliability of, and precision in,  estimates to be used for decision making. Estimates of the Gen-2  system’s limits of detection, produced by the four key tests described  earlier, contain multiple sources of uncertainty, which we describe in the  next section of this report. None of the modeling and simulation studies  that were provided or described to us incorporated information about the  uncertainties associated with estimates of the system’s limits of  detection.

We also found that these studies did not account for uncertainty in some  model inputs and assumptions, including estimates of how infectious  each of the BioWatch threat agents is and how quickly each agent decays  after it is released in the air. For example, Sandia researchers and a  subject matter expert told us that there is considerable uncertainty in even  the best available estimates of the infectious dose of anthrax, as these  estimates are based on data from nonhuman primates. In an earlier  study, Sandia researchers and others reported that “gaps in our  knowledge of the correct dose-response relationship significantly limit our  ability to predict the outcome of outdoor anthrax attacks.” For many of  the assumptions the Sandia models used, researchers dealt with  uncertainty by using not just single estimates but ranges of estimates.  However, for the infectious doses of the five BioWatch threat agents,  researchers used single estimates that DHS provided. The uncertainty in  these estimates is important because DHS officials have characterized  the operational objective of the BioWatch system as detecting attacks  large enough to cause 10,000 casualties. In order to assess the system’s  capability to achieve this objective, DHS must be able to correctly define  the types and sizes of attack that fall into this category. If anthrax were  less infectious than the models assumed, then DHS would be  underestimating the system’s ability to detect catastrophic anthrax  attacks. Conversely, if anthrax were more infectious than the models  assumed, then DHS would be overestimating the system’s ability to  detect such attacks. We recognize that more precise infectious dose  estimates may not exist, but this underscores the uncertainty in the ability  of the BioWatch system to meet its operational objective—uncertainty that  should be articulated to better inform decision makers about the  capabilities of the Gen-2 system and inform cost-benefit decisions about  any possible enhancements to the system.

section_title: Limitations and Uncertainties in Test Results
paragraphs: We found limitations and uncertainties in the four key tests of the Gen-2  system’s performance characteristics—in particular, in the use of test  chambers instead of operational environments and the use of simulants in  place of live biothreat agents. As noted earlier, it is not possible to test the  BioWatch system directly by releasing live biothreat agents into the air in  operational environments. Because of this constraint, which is beyond  DHS’s control, the agency commissioned tests that involved aerosols in  test chambers or were limited to components of the system for which  aerosols were not necessary. Further, officials and experts told us there  are no test chambers where testing the Gen-2 system with live agent is  technically feasible; thus some tests have involved simulants in place of  live biothreat agents.

Using laboratory chambers and simulants effectively addressed certain  challenges, but both introduced uncertainties into testing results.  Chambers often differ from operational environments in ways that can  affect a system’s performance. For example, chamber environments are  generally not designed to be representative of operational environments  in such factors as air temperature, humidity, and, according to an expert,  the presence of potential interferents in the air. Similarly, simulants may  not mimic the biothreat agents that the system is designed to detect in all  of the ways that matter for system performance; therefore, the system  might perform differently when presented with the target biothreat agents  than when tested with simulants. As a result, chambers and simulants  create uncertainty as to whether test results accurately describe how the  system would perform in an operational environment against live  BioWatch threat agents, and this uncertainty should be clearly articulated  for decision makers.

Additionally, while one of the four tests assessed the performance of the  whole Gen-2 system, the three other tests were limited by their focus on  components of the system, including (1) the aerosol collection  component; (2) the filter wash process, in which aerosol particles are  transferred from the filter into a liquid solution; (3) the DNA extraction  process, in which genetic material is extracted from the particles in liquid  solution; and (4) the analytical component, in which PCR assays are used  to detect genetic signatures of the BioWatch threat agents. According to a  National Research Council (NRC) committee, it is uncertain whether test  results from individual components of a biodetection system will  accurately reflect the performance of the whole system. An expert told  us that components may perform differently when combined than when  tested separately, and parts of samples may be lost during transitions  from one component to another in ways that affect the end-to-end  performance of the system.

DHS took steps to mitigate the limitations associated with not testing the  Gen-2 system in an operational environment with live biothreat agents,  but these limitations could not be eliminated entirely. For example, to  address the fact that killed agents might not perfectly mimic live biothreat  agents, the Dugway tests included a direct comparison of live and killed  agents, but this could be done only for the analytical component of the  system (that is, the PCR assays). The Edgewood Chemical Biological  Center test of the aerosol collection component included variations in  temperature and humidity. This somewhat mitigated the fact that  chambers may not be representative of operational environments;  however, only a small number of combinations of temperature and  humidity were tested, and an expert told us other characteristics that  might differ between chambers and operational environments were not  varied. The Los Alamos National Laboratory tests of the PCR assays  included testing the assays with a set of environmental organisms and  substances. However, this test was limited to the specific organisms and  substances used, and results do not generalize to other organisms and  substances that might occur in BioWatch operational environments. In  sum, although the key tests of the Gen-2 system took steps to mitigate  limitations, uncertainties remain, and test results constitute only limited  measures of key system performance parameters in an operational  environment.

While challenges associated with testing a system like BioWatch make  some limitations unavoidable, according to experts and agency officials,  we found that some limitations could likely have been mitigated. In 2004,  an NRC committee proposed a framework for testing biodetection  systems that was designed to minimize the uncertainties associated with  laboratory chambers and simulants. In this framework, both the whole  system and its components are systematically tested with simulants and,  where possible, live biothreat agents. This is done in both laboratory  chambers and environments that are more representative of operational  environments where the system will be deployed. Importantly, this  framework entails an integrated, systematic approach to testing in which  some factors (e.g., agents, simulants, and environmental factors) are held  constant while others are varied. The committee recommended focusing  on a certain category of simulants, known as killed related strains, that  have potential to mimic live biothreat agents while also enabling more  realistic and frequent testing. The overall goal of the NRC framework is to  home in on the true performance of the system when challenged with live  agents in an operational environment—and, in so doing, to reduce the  risk that the system will perform differently in the real world than it did  during testing.

DHS has not systematically tested the Gen-2 system under the most  realistic possible conditions. Although DHS officials said they based their  approach to testing Gen-2 on the NRC framework, we found that the  Dugway test of system sensitivity did not incorporate killed related strains  as simulants, as recommended by the NRC. Killed related strains would  offer greater flexibility for use in more operationally representative  environments. Furthermore, the Dugway test did not attempt to  incorporate potential environmental interferents. As noted earlier, DHS  also commissioned a demonstration that the Gen-2 technology could  detect a simulant in an outdoor environment. However, aerosol  concentrations were not varied systematically and measured  independently in such a way as to produce statistical estimates of the  system’s sensitivity. Furthermore, this open-air demonstration involved a  simulant for just one of the five BioWatch threat agents, and, unlike the  killed related strains recommended by the NRC, this simulant required  that the system be modified to use a different PCR assay than is used for  the actual threat agent. A GAO subject matter expert on outdoor testing of  biodetection systems with simulants assessed the Dahlgren trials to be  deficient in the equipment that was used to characterize the aerosols; if  alternative equipment known as slit-to-agar samplers had been used,  they could have provided more useful information on aerosol  concentrations and exposure times. According to this expert, additional  problems were associated with an inadequate dissemination system and  inadvisable testing at wind speeds below 2.0 meters/second. In general,  DHS’s understanding of the performance characteristics of the current  system would benefit from a more systematic approach to testing under  more realistic conditions.

In the next year, some Gen-2 equipment will reach the end of its lifecycle,  and DHS will need to make decisions about reinvesting in the program.  Further, DHS officials told us they are considering potential improvements  or upgrades to the Gen-2 system. Based on OMB guidance, cost-benefit  decisions about investing in new equipment and in potential system  improvements will require information about current operational  capabilities. However, because of the limitations we have identified,  decision makers are not assured of having sufficient information to ensure  future investments are actually addressing a capability gap not met by the  current system. As noted earlier, some limitations in testing are  unavoidable given the nature and purpose of the BioWatch system.  Likewise, some limitations and uncertainties are unavoidable in the  modeling and simulation work that DHS has commissioned to link test  results to operational capabilities (e.g., the uncertainty in infectious dose  estimates for the BioWatch threat agents). These limitations underscore  the need for a full accounting of statistical and other uncertainties, without  which decision makers lack an understanding of the precision in what is  known about the system’s capability to detect attacks of defined types  and sizes and cannot make informed decisions about possible upgrades  to Gen-2.

section_title: Gen-3 Testing Partially Aligned with Best Practices, and Gen-2 Upgrades Could Benefit by Applying Lessons Learned
paragraphs: In 2013, in collaboration with the National Academies, we identified eight  best practices for developmental testing of threat detection systems.  When comparing DHS’s actions and decisions regarding the planned  acquisition and testing of Gen-3, we found that DHS’s actions partially  aligned with these best practices. We also identified several lessons DHS  could learn by applying these practices more systematically to improve  future testing and acquisition efforts—for example, testing of possible  upgrades or enhancements to Gen-2. We also highlight the testing of  other DHS acquisitions that faced challenges.
subsections: section_title: Best Practices and Lessons Learned from Gen-3 Phase I Testing
paragraphs: Role of Developmental Testing  Developmental testing is intended to assist in  identifying system performance, capabilities,  limitations, and safety issues to help reduce  design and programmatic risks. According to  experts recruited in coordination with the  National Academies, the best practices they  identified apply to the process of  developmental testing of binary threat  detection systems; they also apply if the  tested system is commercial-off-the-shelf  (COTS), modified COTS, or newly developed  for a specific threat detection purpose by a  vendor or the government.

In previous work, in collaboration with the National Academies, we  recruited experts to develop best practices for developmental testing of  binary threat detection systems. According to the experts, the best  practices apply if the system is commercial-off-the-shelf (COTS), modified  COTS, or newly developed for a specific threat detection purpose by a  vendor or the government. In discussing the role of testing early in an  acquisition, officials from S&T’s Office of Operational Test and Evaluation  (OT&E) said programs face a significant challenge in acquiring COTS  products, like the BioWatch Gen-3 acquisition, because these products or  systems are not designed to operate or initially tested with the same  requirements needed by the federal government. Typically, OT&E officials  said, program officials underestimate the testing needed to acquire a  COTS product for their mission, but said testing is needed to ensure the  COTS solution is reliable, scalable, and secure. We reported in 2012 that  according to BioWatch program officials, developing autonomous  biological detection had proved challenging, in part because some of the  technology required was novel, but also because even the existing  technologies—for example, the aerosol collection unit and the apparatus  that reads the PCR results—had not been combined for this specific  application in an operational environment before. S&T OT&E officials  reflecting on the acquisition said Gen-3 Phase I testing became  developmental in nature, with additional steps built into the test design to  ensure the technology could progress to the next level, particularly to  ensure assay detection met the program’s requirements.

We consider the best practices for developmental testing applicable to  Phase I of the Gen-3 acquisition because they could have helped identify  challenges early in the acquisition process. Additionally, applying the best  practices and lessons learned during the Gen-3 testing could help  mitigate the risk that DHS acquires immature technology as part of its  effort to make enhancements to Gen-2. Appendix I has more information  on our methodology for developing the best practices, and appendix III  has a description of each best practice. Our analysis of DHS’s alignment  with the eight best practices for developmental testing of Gen-3 follows  below and is summarized in table 2.

DHS’s Actions Partially Aligned with Best Practice 1  DHS took some risk-mitigating steps during Gen-3 Phase I, but did not  conduct a full risk assessment at the outset of the acquisition. According  to program officials, Phase I of the overall Gen-3 acquisition was itself a  risk mitigation activity, designed to assess the capability of industry to  provide mature autonomous detection solutions before committing to a  rapid and extensive program to procure and field operational systems.  For example, according to BioWatch program officials, DHS conducted  market research to assess whether solutions potentially capable of  meeting DHS performance and maturity (and therefore schedule)  requirements existed. In an effort to ensure accountability, OHA held a  “Demonstration Day” early in the Phase I source selection process, where  vendors participated in tests designed to confirm their technical maturity  claims. This reduced (but did not eliminate) the risk of awarding Phase I  contracts to a vendor not capable of completing the tests planned under  Phase I. Additionally, officials said OHA initially planned to conduct all  testing in parallel. However, because of schedule slips associated with  contract issues, program officials ended up scheduling the tests  incrementally to allow for the insertion of decision points on whether  testing should continue. This allowed program officials to engage in the  testing and evaluate test results to help reduce technical and financial  risk. As a result of this multi-stage Phase I testing approach, DHS  identified limitations to one vendor’s detection system that could not be  overcome before proceeding with the next stages of testing.

DHS Could Apply Lessons Learned  An earlier evaluation of risk may have eliminated difficulties with cost and  schedule estimates of the Gen-3 acquisition that in part led to its  cancellation in April 2014. According to this best practice, risk needs to be  assessed when the system is COTS, modified COTS, or a newly  developed system, because even with commercial items, significant  modifications may be needed. DHS ultimately performed a formal risk  assessment of the Gen-3 acquisition but not until after Phase I testing  ended. The absence of a risk assessment at the start of the acquisition  led to challenges that the acquisition could not overcome because of its  inflexibility. In 2012, we reported that DHS did not fully engage in the  early phases of its acquisition framework to ensure that the acquisition  pursued an optimal solution in the context of its costs, benefits, and  risks. Our prior work has found that stable parameters for performance,  cost, and schedule are among the factors that are important for  successfully delivering capabilities within cost and schedule expectations.  Our work has also found that without the development, review, and  approval of key acquisition documents, agencies are at risk of having  poorly defined requirements that can negatively affect program  performance and contribute to increased costs. For example, despite  having limited assurance that the acquisition would successfully deliver  the intended capability within cost and on schedule, the Deputy Secretary  approved the initial stages of the acquisition. DHS’s Post Implementation  Review Report, which lays out lessons learned on the Gen-3 acquisition,  states that the Phase I testing demonstrated that schedule risk analyses  should be used to set realistic test and evaluation schedule expectations.  According to program officials, they set the acquisition schedule estimate  aggressively because there was pressure to quickly deploy an  autonomous detection capability. However, schedule revisions were  needed because of significant changes in performance, deployment  schedule, and cost expectations as a result of the Phase I testing.

By not engaging in the initial steps of the acquisition framework to  effectively account for risks early in the acquisition, DHS did not  demonstrate full accountability and exceeded its cost and timeframe  estimates. As a result of the Phase I testing, and on the basis of outside  reviews of the Gen-3 acquisition, DHS directed OHA to conduct a more  robust analysis of alternatives that included assessing risk. This led to the  cancellation of the Gen-3 acquisition in April 2014. The identification of  potential risks, and strategies to overcome these risks, helps ensure  accountability on the part of the agency and may alleviate problems with  the acquisition of threat detection systems if they are part of the early  planning for testing. As DHS considers upgrades to the currently  deployed Gen-2 BioWatch system or considers the acquisition of new  detection technologies, early identification of risks may help better guide  DHS by identifying areas for enhanced engagement that may be needed  during the testing and to help ensure proper accountability for decision  making during the acquisition.
subsections: section_title: Practice 2: Include Representatives from the User Community in Design and Developmental Testing Teams to Ensure Acceptance of the System by the User Community
paragraphs: Acquisition Decision Event (ADE) 2A  An acquisition decision event, where the  Acquisition Review Board—a cross- component board of senior DHS officials— determines whether a proposed acquisition  has met the requirements of the relevant  Acquisition Life-Cycle Framework phase and  is able to proceed. ADE-2A is the culminating  event for the Analyze/Select phase of the  DHS acquisition framework, where DHS  determines whether to authorize the  acquisition to proceed to the Obtain phase,  where testing and evaluation occur.

DHS did not sufficiently involve the end user community in the  development of Gen-3 system requirements or parts of Phase I testing;  rather it relied on internal subject matter experts to develop  requirements. As we reported in 2012, the process used to set the  sensitivity requirement did not reflect stakeholder consensus about how  to balance mission needs with technological capabilities. Specifically, the  BioWatch program did not prepare a concept of operations (CONOPS)  before ADE-2A. According to DHS acquisitions guidance, in developing  a concept of operations, stakeholders engage in a consensus-building  process regarding how to balance technological capabilities with mission  needs in order to gain consensus on the use, capabilities, and benefits of  a system. For BioWatch, this could include specifying the level of  population protection the system should provide and then specifying the  sensitivity levels needed to provide that level of protection. According to  OHA officials, the high-level capability gaps documented in the mission  need statement (timeliness, population coverage, time resolution, and  cost-effectiveness) were representative of feedback from this user  community with respect to improvements needed on the Gen-2 system,  particularly for indoor deployment. Therefore, officials said they did not  directly involve jurisdictional public health stakeholders in establishing the  technical requirements, including sensitivity requirements, for Gen-3.

Role of Subject Matter Experts (SMEs) in  Developmental Testing  Distinct from the user community, SMEs  provide independent technical advice and  monitor the status of developmental testing to  help ensure tests are conducted and analyzed  properly—a practice the National Academies  has supported for BioWatch. SMEs may  include test designers, engineers, and  statisticians. For a program like BioWatch,  SMEs may have expertise in epidemiology,  environmental health, public health laboratory  systems, infectious diseases, genetics, and  detection technology, among other  disciplines. Department of Homeland Security  (DHS) acquisitions policy includes guidance  on using independent technical advisors as  part of the test and evaluation process. For  example, an operational test agent (OTA) is  an independent entity that supports  development of the  test and evaluation  master plan (TEMP) and monitors  developmental testing in order to understand  system performance early and determine how  to execute integrated developmental and  operational testing. The OTA presents  objective and unbiased conclusions in reports  and test readiness reviews. DHS guidance  also describes the role of the Integrated  Process Team, which is composed of  representatives from program leadership,  stakeholders, and SMEs involved in testing  activities.

OHA relied on in-house experts and other department officials who they  said had the expertise to convert the high-level mission needs into  detailed technical performance requirements. These included  requirements for system sensitivity, time needed to detect an attack, and  the probability of false positives, among other things. According to OHA  officials, jurisdictions (especially the four that were selected for OT&E)  were kept informed through meetings with the program office,  independent test agencies, and the two competing vendors in the Phase I  testing. OHA officials also said they conducted numerous updates at  events such as the National BioWatch Stakeholders Workshop, webinars,  and invitations to all jurisdictions to submit questions to the Gen-3 or  BioWatch program managers. According to OHA officials, the end user  community was also invited to observe testing at two special testing  events during Phase I. However, informing end users of the status of  testing is not the same as including them in the development of  requirements and testing. If DHS had involved end users as part of the  testing process, it could have shed additional light on the potential  challenges for end users to operate the technology being considered. For  example, an official who tested the NG-ADS system described months- long training that was required to understand the systems being tested  and evaluated. More closely involving the end users in the testing may  have revealed additional end user views on their ability and willingness to  use the equipment, given its complexity. Additionally, in December 2010,  the Undersecretary for Management issued an ADM that, among other  things, highlighted the continued need to develop a CONOPS, citing  significant risk to the program because of the high-level coordination  required for acting upon detection information produced by the  autonomous detection system and that there was insufficient detail in the  program documentation describing the necessary coordination process  among end users and other stakeholders.

DHS Could Apply Lessons Learned  DHS recognized in its Post Implementation Review that stakeholders and  end users need to be involved earlier in the acquisition process, including  validating advanced detection systems and methods before they are  fielded. To better understand the needs, concerns, and capabilities of the  user community, in the future, DHS could take steps to engage with  stakeholders early on in the development process. As DHS considers  upgrades to the current Gen-2 system, DHS should, in accordance with  DHS acquisition guidance, prepare a concept of operations and ensure  end users are engaged throughout the testing of upgrades or  enhancements to the Gen-2 system or new acquisitions for BioWatch.

section_title: Practice 3: Take a Systems Engineering View of the System prior to Entering into Any Developmental Test
paragraphs: DHS’s Actions Partially Aligned with Best Practice 3  The systems engineering approach was outlined in the Gen-3 test and  evaluation master plan (TEMP), which was generally clear in defining the  boundaries of the system to be tested. The tests were for the most part  appropriately scoped given the systems engineering view that was taken.  However, testing revealed that evaluation of these detection systems may  benefit from more robust testing methods, particularly to test performance  against environmental contaminants. The primary purpose of the Phase I  testing was characterizing the systems’ performance through a series of  tests that included an aerosol collection subsystem test, evaluation of  assays, an analytical subsystem test, a system chamber test, and a field  test. The TEMP clearly identified these test boundaries and stated that all  technologies must meet the five key performance parameters (KPP)  during Phase I testing before selection would be made and Phase II  testing (operational testing) was initiated. KPPs included detection of the  biological agents, system sensitivity, the time to detect, achieved  availability (for example, the probability the detector will operate under  normal conditions), and the probability of a false positive.

The TEMP recognized inherent limitations to the systems engineering  testing for the Gen-3 system. For example, whereas the environmental  conditions under which the Gen-3 system must operate were outlined in  the TEMP, no chamber yet exists in which these requirements can be  fully tested. In addition, according to DHS officials, legal constraints,  public safety, and public perception limit the type of material that can be  aerosolized in a realistic setting for test purposes. The TEMP outlined the  systems engineering approach for Gen-3 testing by articulating the major  issues that needed to be addressed in testing the system, including the  key performance parameters, and accounted for the limitations given  constraints on the type of testing that can be done.

DHS Could Apply Lessons Learned  Although DHS clearly articulated the boundaries of the testing for Phase I  and took steps to test the autonomous detectors against likely  environmental contaminants that might interfere with detection, the  systems engineering approach could have benefited from more robust  and comprehensive testing methods. For example, tests at Dugway also  attempted to account for the possibility that environmental pollutants  might interfere with the performance of the PCR assays by placing  samples in liquid solutions taken from actual BioWatch filters retrieved  from operational environments. However, researchers told us they were  unaware of which operational environments the filter washes had come  from, and there was no sub-analysis by type of environment (e.g., outdoor  versus indoor versus subway), which raises the possibility that pollutants  from certain environments may not have been represented in the test or  that pollutants from certain environments may have been diluted with filter  wash from other environments. The pooled filter wash was used to test  the Gen-3 analytical process in order to look for possible inhibition (e.g.,  interference) of the PCR assays. Officials said that during the Gen-3  testing, the pooled filter wash used to test the analytical process never  showed interference in acquiring a result to an extent that would have  required additional testing steps.

However, in the final Phase I test, DHS fielded detectors in Chicago to  demonstrate the performance of the candidate technology’s full system in  a representative environment. Results of the testing showed that the  candidate system’s performance was inconsistent in different operational  environments. Specifically, detectors located on underground subway  platforms had higher incidences of malfunction than detectors in other  locations. These malfunctions may be associated with the presence of  metallic brake dust, which demonstrates that different operational  environments pose different challenges. Additional rigor in the testing  design could have identified limitations earlier and perhaps mitigated  them prior to the field testing in Chicago. In fact, the final report by the  National Assessment Group on the operational assessment of the Gen-3  Phase I testing concluded that in retrospect, and based on the outcome of  testing in the Chicago field test, levels of some possible environmental  inhibitors, such as metallic brake dust, represented in the Dugway testing  were significantly diluted or did not represent a concentration that  compared with concentrations in some of the more problematic operating  environments. Therefore, a more robust systems engineering approach to  testing contaminants may have helped identify challenges like this earlier.  The BioWatch program office agreed that the limited environmental  contaminant testing was insufficient to draw any conclusions about  system performance on this issue. According to program office officials,  the program planned to implement robust interferent tests during Phase II  to characterize performance against all of the operational requirements  and said Phase I was only meant to characterize the state of the market  for autonomous detection systems. However, the TEMP for Gen-3 states  that the goal of Phase I testing was to evaluate the ability of the candidate  systems to meet performance requirements specified in an operational  requirements document (ORD). The ORD for Gen-3 specifically outlines  the indoor and outdoor environmental conditions under which the system  is expected to operate, including, but not limited to, exposure to dust,  metallic dust, diesel exhaust, pollen, rain, snow, ice, wind, salt spray, as  well as ranges in temperature, humidity, and altitude. DHS’s plan to defer  more robust testing of conditions representative of Gen-3’s intended  operational environment does not align with best practices, as  performance problems uncovered in later stages of testing can be more  costly and require additional testing.

While a basic approach to account for environmental contaminants was  included in the systems engineering approach, the program office  recognized that the results of the field testing highlighted additional  limitations to the test approach for environmental contaminants. The  BioWatch program may benefit by incorporating this lesson learned when  designing future testing approaches for upgrades or enhancements to the  Gen-2 program.

section_title: Practice 4: Use Statistical Experimental Design Methodology to Establish a Solid Foundation for Developmental Testing
paragraphs: DHS Partially Aligned with Best Practice 4  DHS included statistical experimental design in its Gen-3 testing plans in  order to test performance and characterize uncertainty in the test results.  However, the statistical experimental design constructed by DHS was not  sufficient to estimate system performance in a realistic environment and  did not link KPPs in the ORD to overall program objectives via creation  and use of an appropriate model of system performance. In the analytical  subsystem test, conducted at Dugway, the candidate Gen-3 system was  challenged with aerosols of different concentrations in order to estimate  its probability of detection for four of five BioWatch threat agents.  Concentrations were systematically varied and were selected using a  statistical method that was designed to yield reliable estimates of the  system’s probability of detection as efficiently as possible (i.e., reducing  the experimental effort required to obtain sufficiently reliable information).  Statistical uncertainties were calculated for the resulting estimates, and  statistical modeling was used to characterize the relationship between  aerosol concentration and the system’s probability of correctly detecting  the presence of each biothreat agent. Statistical experimental designs  were also used in the tests of the aerosol collection component,  conducted at Edgewood Chemical Biological Center, and the PCR  assays, conducted at Los Alamos National Laboratory. Additionally, the  Gen-3 tests included experimental conditions designed to account for  factors seen in operational environments, though we have identified  limitations in some of these tests, as discussed earlier in the report.

DHS Could Apply Lessons Learned  According to this best practice, test design should be based on a clear  understanding of goals and incorporate users’ needs. This could be  achieved, for example, by linking KPPs in the ORD to overall program  objectives and user needs via creation and use of an appropriate model  of system performance, but this was not done prior to the Gen-3 testing.  Operational requirements, from which the KPPs were derived, were not  clearly linked to an overall mission need or program goal. The absence of  these linkages among mission need, requirements, and parameters for  measuring system performance means results from the Gen-3 testing  cannot speak to whether the system would address an established  mission need or users’ needs. According to program officials, the  operational requirements outlined in the ORD were directly linked to the  approved Mission Needs Statement for Gen-3. However, in 2012, we  reported that officials were aware that the Mission Needs Statement did  not reflect a systematic effort to justify a capability need and we reported  that the program wrote the Mission Needs Statement later to justify a  predetermined solution of acquiring an autonomous detection capability.

Additionally, these tests did not cover all of the system requirements  specified by the ORD. For example, one of the system requirements was  a maximum false positive rate. DHS noted in the TEMP that the  probability of false positives would be estimated from test results using  statistical techniques; however, the TEMP did not explain how this would  be done. In testing, DHS did not address this. Instead DHS tested 20  times (per agent) in the assay tests and 15 times (per agent) in the  Dugway tests, and drew conclusions despite not having designed  experiments that would produce estimates of the system’s false positive  rate with defined levels of statistical precision.

By using statistical experimental designs in the testing of the Gen-3  technologies, DHS was able to characterize some uncertainty in the test  results. However, DHS was not able to determine with a defined level of  statistical certainty the false positive rate, and thus was not able to  conclude that any tested system or system component satisfies its stated  requirement. As DHS considers upgrades to the Gen-2 system or future  technology switches for the BioWatch program, DHS could apply lessons  learned from the Gen-3 testing to help develop meaningful requirements  that are linked to a mission need and where operational objectives (e.g.,  lives saved) are linked to measurable KPPs, such as system sensitivity.  DHS could also use statistical experimental design in future testing of  upgrades or enhancements to the Gen-2 system to help characterize  uncertainty in results and ensure a representative range of operating  conditions are sufficiently used to test system performance.

section_title: Practice 5: Measure and Characterize System Performance with Established Procedures, Methods, and Metrics
paragraphs: DHS’s Actions Partially Aligned with Best Practice 5  DHS created and executed a well-articulated, but incomplete, plan for  measuring and characterizing certain aspects of system performance  using established procedures, methods, and metrics. For example,  measuring system performance included ranking and scoring by agent  the system’s ability to detect known strains of an agent, including near- neighbor strains of an agent, and ability to detect agents with possible  environmental contaminants present. System sensitivity was  characterized using an adaptive methodology to determine, for a range of  concentrations of agents, the probability of detection at each  concentration. These probabilities were associated with confidence  intervals to allow assessment of the range of performance one may  expect. Both live and killed agents were used to assess detection  sensitivity so that results from component testing could be extrapolated to  whole system performance, because currently no facilities exist to  perform whole-system live agent testing. Additionally, DHS evaluated  suitability requirements by testing variables such as human factors;  reliability, availability, maintainability (RAM); supportability; and  survivability in an operational environment.

DHS Could Apply Lessons Learned  Whereas the TEMP and other test plans list the five KPPs for the Gen-3  BioWatch candidate systems, there is no specific link between these  metrics and the mission objectives for the Gen-3 system. Further, it is not  clear how the results of testing in non-representative environments would  be used to determine system suitability for Gen-3 purposes. In addition to  these best practices, developmental testing guidance indicates that  developmental testing is intended to vet systems early to determine the  suitability of the system for meeting performance requirements. By testing  in a variety of modes intended to replicate an operating environment,  results of the tests can be used to characterize and evaluate relevant  system performance. However, the tests that were intended to account  for factors seen in operational environments were of limited range and  scope. For example, the test plan for the Chicago field test suggested  that the system would be exposed to dust, metallic dust, smoke, diesel  exhaust, and pollen, under extended temperature, altitude, and relative  humidity ranges. However, there was no design of statistical tests  intended to address these variations in Phase I. The analytical sub- system testing did not allow for sub-analysis of pollutants from different  environments (e.g., outdoor, indoor, subway), and so it was not possible  to identify effects of any specific pollutant, such as subway brake dust.  Additionally, the Edgewood test of the aerosol collection component  included tests at different temperatures and humidities; however,  relatively few combinations of temperature and humidity were tested, a  fact that limited the range of environmental conditions represented and  limited the utility of their results in determining how the system would  perform under various operational environments.

Because DHS performed only limited testing in this regard, it was not able  to draw conclusions early in the testing process to determine whether the  systems would meet performance requirements. In the future, DHS could  improve BioWatch testing efforts by incorporating clearly articulated  measures and use of established procedures, methods, and metrics to  characterize system performance. This will help ensure DHS collects the  information it needs to evaluate operational suitability of upgrades or  enhancements to the Gen-2 system.

section_title: Practice 6: Test to Build in Resilience, Especially in the Development Stages
paragraphs: DHS’s Actions Partially Aligned with Best Practice 6  DHS performed some testing that could help build resilience into the  system during Phase I testing, but it could improve resilience testing with  more rigorous methods. According to OHA officials, the Phase I  acquisition and test and evaluation (T&E) strategies were specifically  designed to address the concern of identifying potential vulnerabilities in  the systems under test. As part of this strategy, for example, Edgewood  tested the collection efficiency of the filters under varying temperature and  humidity conditions. The system was also tested in an operational  environment in Chicago to assess the effects of environmental  interferents, among other things, to help identify vulnerabilities in  operating the system. Further, DHS recognized that developing  autonomous detection had proved challenging because in addition to  some of the technology required being novel, even the existing  technologies—for example, the aerosol collection unit and the apparatus  that reads the PCR results—had not been combined for the specific  application of autonomous detection in an operational environment  before. By executing assay evaluation and subsystem- and system-level  characterization tests incrementally, this allowed for the insertion of  decision points to reduce technical and financial risk. As a result of its  multi-stage approach to testing the systems, DHS identified limitations to  one vendor’s detection system that could not be overcome before  proceeding with the next stages of Phase I testing, so that vendor did not  complete the entire Phase I testing plan. DHS also included provisions in  the Phase I contracts for engineering change proposals to allow the  vendors, at DHS discretion, to address deficiencies found during testing  to inform DHS decisions on proceeding to Phase II.

DHS Could Apply Lessons Learned  While DHS took some steps to build resilience into the Phase I testing,  additional rigor could have been built into the testing design to reveal  potential vulnerabilities in the performance of the systems tested. DHS’s  final test in Phase I, designed to test resilience, involved fielding the  detectors in Chicago to demonstrate the performance of the candidate  technology’s full system in a representative environment. DHS was able  to identify some limitations—such as environmental contaminants—to the  detection systems being evaluated. However, this occurred late in Phase  I testing, and represented only a limited cross-section of possible  challenges, including temperature, humidity, and vibrations. For example,  while the test plan for the Chicago test lists a range of temperatures and  humidities the system is expected to operate under, the field testing did  not reflect the entire operational range.

Additionally, other tests on temperature and humidity conditions were  performed in limited combinations, such as high temperature and low  humidity, but not others, such as high temperature and high humidity.  Further, these temperature and humidity tests were done only on the  aerosol collection unit, and not the entire Gen-3 system. Because the  Gen-3 system as a whole was expected to operate continuously under  such conditions, just as Gen-2 currently operates, simply testing one  component, the aerosol collection unit, under a limited combination of  temperatures and humidities does not adequately test the system for  purposes of building in resilience. Some of these conditions may have  provided earlier indications of vulnerabilities that did not arise until near  the end of Phase I testing. For example, to assess the effect of  interferents, Dugway testing used pooled filter washes provided by DHS.  The environments from which the filters came were not provided to  Dugway and interferents from different filters were combined. In doing so,  the effect of individual interferents was diluted. When the systems were  tested in Chicago near the end of Phase I, DHS found that system  problems occurred, attributed to petrochemicals near highways and to  brake dust in subway stations. If specific interferents, such as subway  brake dust, were tested prior to the Chicago testing at representative  concentrations, they may have revealed issues earlier in Phase I.

Other conditions, such as network communication performance, were not  tested or were tested in a limited fashion. According to the final report on  the Gen-3 testing, tests of network communication performance were  modified based on user needs in the Chicago area where this capability  would have been demonstrated. Therefore, network performance was left  undetermined at the end of Phase I testing.

As a result of not including more rigorous testing methods to test  resilience, information about system failures in different environments  was not revealed until late in the Phase I testing. By following this best  practice in future testing of Gen-2 upgrades or enhancements, DHS could  help mitigate risks the agency may likely face in acquiring these types of  threat detection technologies.

section_title: Practice 7: Use Developmental Tests to Refine Performance Requirements
paragraphs: DHS’s Actions Partially Aligned with Best Practice 7  DHS used Phase I test results to determine the likelihood Gen-3  candidate systems could meet performance requirements, but revisions  to performance requirements were based on a modeling study, rather  than the outcome of the Phase I testing. According to OHA officials, at the  time OHA began Phase I planning and execution, there was not a robust  analytical capability to determine mission-based requirements for key  technical parameters (such as system sensitivity). Officials said absent  that, a consensus on the technical parameters was made based on the  collective best judgment of OHA BioWatch Program Office and S&T  Chem Bio Defense subject matter experts. According to DHS officials, the  result was more of a “technology push” requirement than a mission  outcome driven requirement, and was based upon what was believed to  be the state of the art for PCR-based systems. However, as we reported  in 2012, when the technologies were unable to meet the technology push  requirement as determined by some Phase I testing, DHS encountered  delays and uncertainty about how to move forward. In response to these  concerns, the BioWatch Program Office conducted a detailed  requirements analysis through a national lab consortium led by Sandia  National Laboratory. The study assessed the utility of biodetection  systems with varying levels of sensitivity in terms of detection timeliness,  population coverage, and lives saved in a bioterror attack. As we  reported in 2012, the study, which was completed in January 2012,  contained findings that, according to BioWatch Program officials, confirm  that the sensitivity requirement could be relaxed without significantly  affecting the program’s public health mission. As a result, DHS set a  new sensitivity requirement based on the modeling studies.

DHS Could Apply Lessons Learned  According to experts, developmental testing should be viewed as a tool in  helping to refine performance requirements, and a meaningful  performance requirement is one that is not only achievable but also  strives to maximize the fulfillment of a mission need. As we reported in  2012, according to BioWatch program officials, the original sensitivity  requirement was set based on interest in pushing the limits of potential  technological achievement rather than in response to a desired public  health protection outcome. They said that this led to a requirement that  may have been too stringent, resulting in higher costs and schedule  delays without demonstrated mission imperative.

Further, having requirements based on operational objectives would allow  the results from Phase I testing to inform the users regarding the  anticipated capabilities of the system and the likelihood that a tested  system would be able to meet mission needs. According to experts,  developmental testing may help to identify the performance envelope of  the system and inform decisions about refined performance requirements.  Failure of the Gen-3 candidate system to meet the initial performance  requirements resulted in delays and uncertainty regarding the Gen-3  acquisition. DHS took steps to refine the sensitivity requirement for Gen- 3, but it was the modeling study, rather than the developmental testing  protocol, that led to the change. However, we found that even the relaxed  sensitivity requirement did not link system performance to a clear  operational objective (e.g., to detect attacks of certain types and sizes),  as discussed earlier in this report. Instead, the relaxed requirement was  based on ideas about the performance characteristics of the current  (Gen-2) system—the idea being that Gen-3 could be less sensitive than  Gen-2 but still achieve comparable public health outcomes because of its  greater speed. According to DHS, the change in sensitivity requirement  was linked to casualty reduction, and the agency does not agree with our  assessment. However, as noted earlier in this report, the performance of  Gen-2 has not been linked to a clear operational objective; therefore,  because the revised sensitivity requirement for Gen-3 was based on Gen- 2, it was not grounded in an operational objective, either. In any future  acquisition, upgrade, or enhancement to Gen-2, having initial  requirements based more closely on mission need and operational  objectives may prevent delays and uncertainty. In its Post Implementation  Review, DHS also recognized the need to better communicate with  stakeholders about using a flexible testing approach to refine  requirements to avoid any misperception that the requirements would be  adjusted to accommodate the vendor’s capabilities.

section_title: Practice 8: Engage in a Continuous Cycle of Improvement by (1) Conducting Developmental Testing, (2) Conducting Operational Testing, and (3) Incorporating Lessons Learned
paragraphs: DHS’s Actions Aligned with Best Practice 8, as Applicable  DHS took steps to engage in a continuous cycle of improvement during  the Gen-3 acquisition, but not all components of this practice apply, as  DHS never reached the stage of operational testing. In the Gen-3  TEMP, DHS describes an integrated test approach, designed as a  continuum from developmental testing through operational testing, with  the previous test events acting as the foundation for the follow-on events.  However, given the expectation of rapid acquisition and deployment, DHS  missed opportunities to fully engage in a broader testing approach  needed for a novel system approach to biodetection. By not engaging in a  more rigid testing approach, when the autonomous detection systems  tested did not yield favorable outcomes, it raised too much uncertainty  about cost and performance for the program. As a result, DHS canceled  the Gen-3 acquisition and prepared lessons-learned documents for the  Gen-3 acquisition that are intended to inform the BioWatch program’s  actions in the future. This could include applying the lessons learned to  improvements or upgrades to the existing Gen-2 system. OHA officials  reported that following the Phase I testing, the BioWatch program  facilitated lessons-learned conferences that included relevant  stakeholders. For example, OHA officials said results from the Phase I  testing indicated that the basic approach used to assess the technology  worked well and appeared to answer the relevant questions as to the  readiness of a technology considered for deployment. Specifically, they  said testing of major subsystems independently was useful as was the  chamber testing conducted using a killed (nonviable) agent. Other  positive aspects included the usefulness of an interagency test and  evaluation Working Integrated Product Team, and the value of  independent test agencies. According to OHA, lessons learned include  the need for widely accepted PCR Assay Performance standards  (recently reviewed by a National Academies consensus committee) and  the establishment and enforcement of operational performance criteria  during testing to avoid repeated adjustments such as those that were  made by one of the vendors to its agent identification algorithm and assay  chemistry. According to OHA officials, these adjustments delayed the  testing and increased costs.

DHS Identified Key Lessons Learned from the BioWatch Gen-3 Acquisition  1. Any policy decision to accelerate a future acquisition of detection technology should be fully documented, capturing the justification for urgency, an understanding of the limitations of current technology capabilities, and the minimum acceptable (non-technical) requirements needed to achieve the  improvement envisioned.   2. Deliberations regarding biodetection research and development during an acquisition process should have pre-designated forums that are capable of resolving issues (scientific or otherwise) as they arise. An inability to reach resolution or consensus should be documented and openly acknowledged,  allowing for the development of an adjusted path forward for the acquisition process, if necessary.   3. Communication efforts should be increased to Department stakeholders and leadership, both to improve efficiency of the acquisition process and to fully document an acquisition’s updates to any requirements, timelines and/or procedures.  4. State and local government stakeholders, especially in locally-operated programs (such as BioWatch), should be integrated into the requirements generation process as early as possible, recognizing their ultimate role as the end-user.

In April 2014, after assessing the results of the Phase I testing outcomes,  DHS canceled the Gen-3 acquisition when unfavorable testing outcomes  raised too much uncertainty about cost and performance of the  autonomous detection systems tested. While some might consider the  cancellation of the Gen-3 acquisition a failure, by carefully weighing the  pros and cons of moving forward with an acquisition that had not  produced favorable results, DHS incorporated parts of the best practice of  continuous improvement and avoided greater expense for a system that  had not met program requirements. By applying the lessons learned that  DHS identified as a result of evaluating the Gen-3 acquisition, as well as  those identified through application of these best practices for testing,  DHS can continue to engage in a continuous cycle of improvement for its  testing and acquisition of detection technologies as it considers upgrades  or enhancements to the Gen-2 system.

section_title: Lessons Learned from Other DHS Acquisitions of Threat Detection Technologies
paragraphs: BioWatch Gen-3 is one of several DHS technical system acquisitions that  have faced challenges because of system immaturity or unreliable  performance in an operational environment. In some cases, DHS  canceled the acquisitions after testing did not yield favorable results. For  example, we previously found the Secure Border Initiative Network  (SBInet) testing did not appropriately account for risk or provide sufficient  information to ensure system performance. Aiming to enhance border  security and reduce illegal immigration, DHS launched SBInet to create a  “virtual fence” along the border using surveillance technologies. However,  as with our 2012 findings on the Gen-3 acquisition, we found the SBInet  Program Office had not effectively performed key requirements of  development and management practices. For example, some operational  requirements for SBInet, which are the basis for all lower-level  requirements, were found to be unverifiable, and we concluded that the  risk of SBInet not meeting mission needs and performing as intended was  increased. As noted above, the Gen-3 acquisition also did not have  operational requirements directly tied to mission need. Additionally, we  found none of the SBInet plans for tests of system components  addressed testing risks and mitigation strategies. As noted above,  assessing technical and performance risk in an acquisition can help  mitigate cost and schedule problems. Although we made several  recommendations aimed at improving the rigor and discipline of SBInet  testing, DHS canceled the SBInet acquisition in January 2011, in  response to internal and external assessments that identified concerns  regarding the performance, cost, and schedule for implementing the  systems.

Similarly, we previously reported that a primary lesson learned regarding  testing of the Domestic Nuclear Detection Office’s (DNDO) advanced  spectroscopic portal (ASP) was that the push to replace existing  equipment with new technology led to a testing program that lacked the  necessary rigor. The ASP was a type of portal monitor designed to both  detect radiation and identify the source to reduce both the risk of missed  threats and the rate of innocent alarms. DNDO considered these to be  key limitations of radiation detection equipment used by Customs and  Border Protection (CBP) at U.S. ports of entry. Based on our body of work  on ASP testing, one of the primary lessons to be learned is to avoid the  pitfalls in testing that stem from a rush to procure new technologies. We  have previously reported on the negative consequences of pressures  imposed by closely linking testing and development programs with  decisions to procure and deploy new technologies. In the case of ASPs,  as well as the Gen-3 acquisition, the push to replace existing equipment  with the new portal monitors led to a testing program that initially lacked  the necessary rigor. DNDO’s schedule consistently underestimated the  time required to conduct tests, resolve problems uncovered during  testing, and complete key documents, including final test reports. We also  found that testing of the ASPs lacked sufficient rigor to demonstrate  performance of the detectors in an operational environment. For example,  ASP testing did not include a sufficient amount of the type of materials  that would mask or hide dangerous sources that ASPs would likely  encounter at ports of entry, which is fundamental to the performance of  radiation detectors in the field. As noted above, Gen-3 testing of possible  environmental contaminants also lacked sufficient rigor to identify  potential vulnerabilities in the system’s detection capabilities prior to  placing them in the field. Despite several recommendations we made to  DHS on ways to improve the testing and management of the ASP  acquisition, because of unsatisfactory test results, ASP did not pass field  validation testing, which led DHS to cancel the program in October 2011.

DHS has taken several steps in recent years to improve acquisition  management in response to our previous recommendations. By  establishing a policy that largely reflects key program management  practices, dedicating additional resources to acquisition oversight, and  improving documentation of major acquisition decisions in a more  transparent and consistent manner, DHS has improved its ability to  manage acquisition programs. The decision to cancel the Gen-3  BioWatch acquisition is an example of improved oversight, and DHS  could continue to improve by implementing some lessons learned from  the Gen-3 acquisition. In April 2015, we reported that DHS’s Director of  Operational Test and Evaluation has expressed interest in becoming  more involved in testing earlier in the development process to increase  influence over program execution. The Director told us that determining  how test activities should inform key decisions would help mitigate risk for  all types of programs. As DHS considers its options regarding the  currently deployed Gen-2 BioWatch system, including possible  technology enhancements or even future technology switches, future  BioWatch acquisition and testing efforts may benefit by incorporating the  lessons learned from the Gen-3 Phase I testing and other recent DHS  acquisitions that have faced testing challenges.

section_title: PCR Technology Is Most Mature for an Autonomous Detection System to Upgrade Gen-2, but Such Systems Face Uncertain Benefits and Several Likely Challenges
paragraphs: PCR is the most mature and sensitive technology for an autonomous  detection system, and DHS is considering autonomous detection as an  upgrade to Gen-2. While autonomous detection may provide benefits that  include reduction in casualties and clean-up costs and greater cost- efficiency, the potential benefits of an autonomous system for BioWatch  depend on specific assumptions, some of which are uncertain. For  example, reductions in casualties would depend on a rapid, coordinated  response from multiple entities at the federal, state, and local levels;  whether such a response would materialize is uncertain and partially  outside DHS’s control. Further, an autonomous detection system would  have to address several likely challenges, including minimizing possible  false positives, securing a networked detection and communication  system, and operating under various environmental conditions.
subsections: section_title: PCR Is the Most Mature Technology for an Autonomous Detection System
paragraphs: The most mature analysis technology for an autonomous detection  system is currently PCR, according to a National Academies report on  promising technologies for autonomous detection for BioWatch and  interviews with stakeholder officials, including CDC, the DHS BioWatch  program manager, and other experts. As mentioned earlier, while DHS  canceled the Gen-3 acquisition of an autonomous detection system for  BioWatch, OHA and S&T are collaborating to address the capability gap  that Gen-3 intended to fill by evaluating upgrades or enhancements to the  current Gen-2 system. According to DHS officials, autonomous detection  is among the technologies being considered. The National Academies  report presented perspectives from local officials and technological  assessments, gathered from a workshop that DHS requested, to explore  alternative cost-effective systems that would meet the needs for a next- generation BioWatch system. This proposed next-generation system was  intended to operate autonomously to detect BioWatch threat agents from  aerosol samples. The National Academies report described the state of  autonomous detection technology in 2013 and evaluated four broad  classes of technologies (see table 3). Those technologies were PCR,  immunoassays and protein signatures, genomic sequencing, and mass  spectrometry.

Three Key Terms for Understanding  Autonomous Detection Technologies  Genes: Genes are sections of nucleic acids  that determine how proteins are made.  Nucleic acids, such as deoxyribonucleic acid  (DNA), are long chains of molecules made up  of bases, of which there are four possible  kinds. The order of the bases represents the  sequence of the DNA. Because proteins  determine much of the function of an  organism, sequencing the genes can provide  information about its identity. The set of all  genes of an organism is known as its  genome.  Protein signatures: Proteins are long chains  of building blocks called amino acids.  Because there are many types of amino  acids, the way each protein interacts with  different stimuli, such as light, can be unique.  For example, shining one color of light on a  protein can result in its emitting different  colors. The set of colors the protein gives off  can be considered an “optical fingerprint” of  the protein, commonly referred to as a type of  protein signature.  Antibodies: Antibodies are proteins created  by the immune system that attach to specific  chemicals on the surface of disease-causing  organisms, resulting in the organisms’ being  rendered harmless. Antibodies can be  designed to attach to a given target and  modified to be detectable under certain  conditions. Thus it is possible to use  antibodies to see whether a target is present  by soaking a sample with the antibodies,  washing off unattached antibodies, and then  measuring those that remain.

PCR, which is used to detect nucleic acid signatures, is used to amplify  and detect genetic material, or nucleic acids, of organisms. By  amplifying (i.e., repeatedly duplicating) those sections of genes  associated with certain biological agents, it is possible to distinguish the  agents among various organisms. Because of the amplifying capability of  PCR, small amounts of genetic material are sufficient for detection,  resulting in high sensitivity for this technology. Specificity can be high if  the sections of the genes being amplified are unique to the agent.  However, related organisms, called genetic near-neighbors, may contain  similar gene sections and lead to a PCR detection when the agent itself is  not present. PCR is the method used in the current (Gen-2) BioWatch  system.

Immunoassays and protein signatures use antibodies or light to identify  organisms. Immunoassays use antibodies that attach to chemicals that  primarily appear on certain biological agents; thus immunoassays can be  tailored for high specificity. Protein signatures analyze how light interacts  with different chemicals (such as proteins) on target agents, using light  “signatures” emitted by specific proteins to be identified. However, neither  of these methods is as specific as PCR. Also, because there is no  amplification, the sensitivity of these methods is not as high as that of  PCR.

Genomic sequencing provides a genetic sequence for all or part of a  detected organism’s genes. Because each agent contains unique genetic  sequences, this method is very specific and could eventually provide  information regarding antibiotic susceptibility. However, the method is not  considered standalone since it depends on another method, such as  PCR, to work. If used with PCR, then this method is also very sensitive.  Of the four broad technologies examined by the National Academies, this  method is also the least mature because of issues with systems  integration—for example, developing the software to perform the analysis  locally (within the device itself).

Mass spectrometry breaks apart a sample (for example, by directing a  laser onto the sample) and analyzes the resulting fragments. Different  chemicals yield different types and amounts of fragments, so it is possible  to reconstruct the chemical composition of the original sample. Because  the chemical make-up of agents is unique, it is possible to identify their  presence in the sample. Mass spectrometry is not as sensitive or as  specific as PCR.

section_title: Benefits of an Autonomous Detection System Depend on Several Assumptions
paragraphs: We identified key potential benefits of an autonomous detection system  from discussion with agency officials, a review of agency and national  laboratory documentation, and a literature review. Most of these potential  benefits were owing to faster detection; however, we determined that the  extent to which faster detection confers benefits depends on specific  assumptions, some of which are uncertain and some of which are outside  of DHS’s control. Additionally, from our review of literature, we identified  potential benefits that included decreasing user errors, such as dropped  collection filters. However, since these benefits depend on the actual  design and implementation of the system, it is difficult to predict the extent  to which they would be realized. The benefits and challenges discussed  in this report apply broadly to autonomous detection; that is, they do not  depend on which of the four broad classes of technology is deployed.

According to a 2011 National Academies report, an autonomous  detection system could detect agents more quickly than the Gen-2  system because of a shorter sample collection period, elimination of  sample transport, and completion of the detection step within the system  itself (see fig. 3). In particular, the report stated that while the current  Gen-2 BioWatch system could detect agents in 10-36 hours, an  autonomous detection system could detect agents in as little as 4-6  hours. Further, DHS officials and Sandia modeling studies state that  faster detection enabled by automation can provide:  1.  reduction in casualties and/or fatalities because of faster detection  and faster situational assessment;  2.  lowering costs, including clean-up costs by halting the entrance of  transport vehicles, such as trains or airplanes, into contaminated  areas; and  3.  reduction in the total annual cost of the detection system, per  detection cycle.

DHS officials told us that an autonomous detection system would offer  many of these benefits but did not provide evidence to support them,  saying that their assertion is “common sense.” DHS officials also referred  to Sandia’s modeling studies. However, we determined that these  benefits and the conclusions of the Sandia modeling studies depend on  specific assumptions, some of which are uncertain and some of which are  outside of DHS’s control, although DHS officials stated that they believe  the modeling assumptions are reasonable for the intended purpose.  However, a CDC official cautioned against relying on models to determine  program effectiveness.
subsections: section_title: Life-Saving Benefits of Early Detection Are Uncertain and Depend on Factors Outside of DHS’s Control
paragraphs: The number of lives saved from faster detection could not be determined,  because some key factors affecting response time are uncertain. For  example, the time it takes decision makers to determine that a detection  represents a threat to public health and warrants dissemination of medical  countermeasures is variable. The time between a BAR and dissemination  of medical countermeasures may include the time needed to characterize  the incident, determine who was exposed, make decisions regarding  evacuation of contaminated regions and relocation of individuals,  determine where to set up medication “points of dispensing” and to  actually mobilize the medication stockpile, and distribute medication to  potentially exposed people and keep track of who received medication.  According to the National Academies report and current DHS guidelines,  steps taken after detection, to instill confidence for requesting medication,  include assessing known threats, conducting additional local lab work,  and initiating a national conference call (see fig. 4). There may be  additional tasks such as culturing of the agents to determine their viability  and antibiotic resistance. If local stakeholders follow the guidelines, there  could be considerable delay prior to mobilization of stockpiled medication.  For example, an official at the National Academies workshop reported  that he takes an additional hour to perform an assessment prior to any  national conference call. According to another National Academies report,  the BioWatch national conference call usually occurs 1-2 hours after a  local call of the BioWatch Advisory Committee. Thus, the time between  an attack and when medication is fully distributed—and the number of  lives potentially saved by minimizing this time—could vary from  jurisdiction to jurisdiction. DHS officials agreed that the jurisdictional  response can vary and conducts exercises and training to help plan for a  response. However, it is not clear what effect such exercises have on  response time variability.

In addition, faster detection may not be the most effective way to save  lives. For example, a modeling study showed results indicating that an  attack detected in 2 days, but requiring 10 days to distribute medication,  would result in more deaths than an attack detected in 5 days, but  requiring only 2 days to distribute medication. Thus, according to this  model, a jurisdiction that shifts resources from medical distribution  capacity to faster detection may end up with more deaths. Decisions of  resource prioritization are not under BioWatch program control, neither is  the part of the response involving medication or other intervention.  However, the benefits from early detection depend on such resource  prioritization and effective overall responses. DHS officials agree, noting  that biosurveillance is a coordinated, holistic endeavor.

Sandia ran a response model to estimate, among other things, the  number of casualties and fatalities given the time that passes between  the attack and detection (time to detection). Sandia’s modeling studies  showed that a faster detection system would reduce the number of  casualties and fatalities, but that the extent of these reductions would  depend on assumptions in the model. One such assumption was the  probability that BioWatch correctly detected the attack. As discussed  earlier in this report, the probability that BioWatch correctly detects an  attack depends on many factors, including the performance  characteristics of the technology and the characteristics of the attack  itself. Many of Sandia’s estimates of the life-saving benefits of a detection  system—automated or not—are downstream analyses presuming that an  attack was detected. If the attack was not detected, the faster response  enabled by a detection system would not occur, and there would be no  life-saving benefits from operating such a detection system. Therefore, if  those results are read out of context of this presumption, the expected  reductions in casualties and fatalities may be overestimated. This  limitation applies to autonomous detection as well as the Gen-2 system.

Estimated reductions in casualties and fatalities from faster detection also  depend on assumptions about the infectivity of the BioWatch threat  agents. In the Sandia modeling studies, infectivity was represented by  infectious dose estimates—that is, estimates of the doses that would lead  to illness; however, we found uncertainty in these estimates. As described  in our earlier discussion of the current (Gen-2) system, Sandia  researchers and other experts told us there is considerable uncertainty in  even the best available infectious dose estimates for anthrax, as these  estimates are based on data from nonhuman primates.

Finally, the life-saving benefits of faster detection that Sandia reported  varied significantly, depending on the properties of the illness that the  agent caused. These properties included how long it takes for symptoms  to exhibit in a patient after exposure and how effectively medication can  prevent death in ill people. According to Sandia, some agents act very  slowly—that is, they have long incubation periods—which diminishes the  effect of faster detection. For example, an agent that takes over 7 days to  cause symptoms will be detected by a 36-hour and a 4-hour detection  system with similar outcomes. Another factor is how effectively a  developed illness can be treated. According to Sandia, this factor is also  variable, so that for some agents, the numbers of lives saved in shifting  from 36-hour to 4-hour detection change little. Thus, reducing fatalities by  faster detection depends largely on the agent used in an attack.

section_title: The Lowering of Cleanup Costs Is Uncertain because of Traffic Variability
paragraphs: Sandia reported that faster detection improves the ability to divert  transport vehicles—such as trains and airplanes— from contaminated  areas so that they do not have to be subsequently cleaned up. The  benefit’s extent is uncertain because it depends on the amount of traffic  entering a given location. For example, according to Sandia, the number  of subway cars entering New York City’s Grand Central Terminal over a  period of 5 hours can range from as few as 250 to as many as 1,750,  depending on the time of day and the day of the year. Clean-up effort  reduction is thus uncertain because of an attack’s unpredictability. A  similar analysis can be made for people entering a contaminated area— while early detection could lead to exposure prevention and mitigating the  need for additional medication, the actual number of people affected is  similarly variable.

We recognize that much of the uncertainty described regarding lives  saved or reduction in clean-up costs is out of the control of the BioWatch  program. However, when describing benefits of faster detection,  particularly concerning the number of lives possibly saved by an  autonomous system or any early-warning system, it is important to  understand the uncertainties in these assumptions, such as response  time or infectious dose of the agent. Without a comprehensive  enumeration of these assumptions and their effects on the modeling  results, assertions regarding the value of autonomous detection systems  are questionable.

section_title: The Projected Cost Savings for an Autonomous Detection System May Not Materialize
paragraphs: In 2012, we found that DHS performed a limited cost trade-off  assessment of switching to an autonomous detection system that focused  on cost per detection cycle—that is, the cost each time an autonomous  detector tests the air for agents versus the cost each time a Gen-2 filter is  manually collected and tested in a laboratory. We reported in 2012 that  cost per detection cycle was lower with an autonomous detection system,  but that overall annual program costs would increase from the current  Gen-2 system program costs. From figures DHS provided in 2015  regarding the cost of switching to an autonomous detection system with  coverage comparable to that of the current Gen-2 system, our analysis  yielded results similar to our 2012 findings.

To determine potential cost savings between the Gen-2 system and an  autonomous system, DHS compared an autonomous system with a  modified Gen-2 BioWatch system. Gen-2 generally runs one detection  cycle daily, but for DHS’s analysis the agency compared an autonomous  system with a modified Gen-2 system which would run three daily  detection cycles. We determined that total annual program costs would  increase if current operations for Gen-2, which involve one detection  cycle per day, were replaced with an automated detection system. Only  by comparing the total annual program costs of operating Gen-2 with  three detection cycles per day with the total program costs of operating  an automated system were cost savings realized (see table 4). As we  reported in 2012, conducting a more complete analysis of costs and  benefits would help DHS develop the kind of information that would  inform trade-off decisions regarding changes to BioWatch technology.

Automation may lead to additional potential benefits including fewer user  errors and greater efficiency—for example, using fewer resources to  accomplish the same amount of work—and greater worker safety by  facilitating the handling of dangerous materials, according to literature on  automation. However, because automated detection systems have not  been deployed, assessing these benefits is difficult. Additionally,  uncertainty about how the technology will work means that its benefits  might be countered by new problems. For example, according to a 2007  DHS Inspector General report, transferring BioWatch system filters was  done improperly several times in 2004. By eliminating the need for  transporting filters, automation could avoid this problem, but new  problems could arise, such as system crashes. For example, repeated  system crashes occurred when the BioWatch Program Office conducted  a trial deployment of an autonomous detection system, in New York in  2008. Thus, it is not clear that an autonomous system would realize these  benefits.

section_title: Autonomous Detection Systems Must Overcome Several Likely Challenges
paragraphs: The challenges an autonomous detection system must overcome include  ensuring its detection sensitivity and protecting against threats to  networked communications. From a National Academies workshop and  interviews with agency officials, we identified five likely challenges (shown  in fig. 5).

According to DHS, ensuring that the autonomous detection system meets  BioWatch sensitivity requirements represents a major technical hurdle. As  discussed earlier, the original sensitivity requirement for the Gen-3  system was based on a technology push because DHS lacked the  analytical tools needed to generate a mission-based sensitivity  requirement. DHS later revised the sensitivity requirement based on a  Sandia-led modeling study. As we described earlier, the Sandia model is  subject to limitations and assumptions, and how the sensitivity  requirement may be linked to mission outcomes, such as detecting  attacks that lead to 10,000 casualties, remains uncertain. Additionally,  challenges may be associated with designing a technology to meet a  given sensitivity requirement.

One way to manage sensitivity requirements is to assess whether the  technology in a detection system conforms to performance standards.  The standards may be subject to validation by independent groups or  agencies, and constitute guidelines for the technology. For example, the  number of times a test should be run and the verification of reagents are  standardized so that results can be interpreted meaningfully. With the  development of newer technologies for detection, a method known as  multiplexing is being increasingly used. However, validating the use of  multiplexing in detection systems has no performance standards. DHS  commissioned the National Academies to examine performance  standards for PCR, including multiplexed PCR. However, the report  recently released by the National Academies does not provide clear  standards for multiplexing, instead noting that combining Food and Drug  Administration (FDA) multiplexing guidance with certain standards, such  as SPADA, which discuss multiplexing, should form a starting point for  validation testing. The report also notes that changing to multiplexing  (from singleplexing) reduces the sensitivity of the assay, although the  effect of this reduction is unclear. Given that PCR is the most mature  technology for autonomous detection systems, implementing other  technologies may require similar, or greater, effort in establishing  performance standards.
subsections: section_title: The Challenge of False Positives
paragraphs: A challenge for deploying autonomous detection systems identified by  participants at the National Academies workshop is the avoidance of false  positive readings—readings that indicate the presence of an agent that is  not present. False positive readings can lead to major disruption from  shutting down crucial transportation and economic facilities (such as  airports and shopping centers—referred to as high-consequence actions)  and to the unnecessary medication of an uninfected population—which  can lead to adverse effects and medical stockpile waste. Local public  health officials stated that false positives are likely to be a bigger issue  with autonomous detection systems, because operating more detection  cycles could increase their frequency.

According to the National Academies report, another common concern  among public health officials is their credibility when making high- consequence decisions. At the workshop, officials stated that the integrity  of public health is critically important, and thus they needed complete  confidence in an autonomous system, which is intended to provide results  without human interaction or interpretation. Similarly, according to a  Sandia workshop in 2009, public health officials largely felt that wrongly  taken high-consequence actions would result in loss of credibility.  Finally, an LLNL scientist stated that debugging a complex system to  determine whether a potential false positive occurred may be an issue  with some autonomous systems. He noted that false positives from  naturally occurring genetic near-neighbors of the BioWatch threat agents  might be a particular challenge and that DHS has made limited  investments in determining background DNA signatures to address this  issue. DHS officials stated they use data gathered from current  operations to assess such background signatures, but it is unclear  whether this approach would be effective for an autonomous detection  system.

section_title: Ensuring Reliable and Secure Information Technology Networks Is Challenging
paragraphs: According to DHS and CDC officials, another challenge autonomous  detection systems face is securing the networked communication system  against interference, such as from hackers. DHS officials stated that the  security of network communications for transmitting results to the local  officials was an important issue for autonomous detection systems. For  example, during the Gen-3 effort, DHS officials specifically planned for  testing of network security as described in the TEMP. DHS officials stated  that an unsecure system would be vulnerable to hackers’ planting results  or shutting systems down. In 2012, we reported that the 2011 Operational  Assessment stated that failure to demonstrate network security may  seriously inhibit user confidence in the system. A CDC official also  noted that network communication is an area of concern, citing previous  issues with the deployment of related technologies.

section_title: Data Management and Interpreting Results Are Challenging
paragraphs: DHS identified data management challenges for autonomous systems,  including reviewing the reported data and interpreting the data to  determine appropriate follow-up actions. A participant at the National  Academies workshop expressed concern over a system that would  provide data every few hours, leading to strain on limited and diminishing  public health resources. DHS describes system data as containing  information on how the detector was functioning as well as laboratory  analysis data. According to DHS, data from an autonomous detection  system would need to be reviewed by local or state staff across the 24/7  reporting period. Further, those staff would need to be trained in  appropriate data interpretation. According to DHS officials, the cost for  these local public health resources is not included in their cost projections  of the autonomous BioWatch calculations.

section_title: Maintaining Autonomous Detection System Operation Is Challenging
paragraphs: Finally, DHS officials stated that keeping the autonomous detection  system continuously functioning in a dirty environment is challenging.  Additionally, an LLNL official stated that a dirty environment can contain  chemicals that interfere with the technology used to detect the agent. As  we reported in 2012, and according to the 2011 Operational Assessment  on Gen-3, autonomous detection systems during the Gen-3 acquisition  experienced malfunctions, exhibited issues with the positive controls, and  required unscheduled maintenance, attributed to either traffic emissions  due to proximity to an interstate, or to metallic dust generated by train  brakes. This underscored the challenge of an autonomous detection  system needing to operate in different operational environments. In  addition, according to the Analysis of Alternatives conducted by the  Institute for Defense Analyses in 2013, detection systems are vulnerable  to vandalism and accidents.

section_title: Conclusions
paragraphs: BioWatch’s rapid deployment in 2003—to provide early detection of  potentially catastrophic aerosolized biological attacks—did not allow for  sufficient testing and evaluation against defined performance  requirements to understand the system’s capabilities. Since that time,  DHS has commissioned tests of the system, but has not defined technical  performance requirements that would link test results to conclusions  about the types and sizes of attack that the Gen-2 system could reliably  detect. DHS has also commissioned modeling and simulation studies, but  none of these studies was designed to directly and comprehensively  assess what is known about the capabilities of the currently deployed  system, using specific test results and accounting for statistical and other  uncertainties. Finally, while DHS has addressed certain limitations in  testing, it has not systematically tested the system against realistic  conditions, and there remains potential to reduce risk and uncertainty in  what is known about the system’s capabilities when deployed in a real- world environment. As a result of these gaps and limitations, considerable  uncertainty remains as to the types and sizes of attack that the Gen-2  system could reliably detect. DHS officials have stated that the system’s  operational objective is to detect attacks large enough to cause 10,000  casualties, but DHS cannot conclude with any defined level of statistical  certainty that the system can reliably achieve this objective. In the wake  of the cancellation of the Gen-3 acquisition, DHS is planning for  technology upgrades or improvements to the Gen-2 system, and some  Gen-2 equipment is nearing the end of its life-cycle and will need to be  replaced if the program is to continue. However, effective and cost- efficient decisions cannot be made regarding upgrades and  reinvestments if the operational capabilities of the Gen-2 system are  uncertain. Assessing the operational capabilities of the Gen-2 system  against technical performance requirements directly linked to an  operational objective, incorporating specific test results, and explicitly  accounting for statistical and other uncertainties would help ensure that  decisions about future investments are actually addressing a capability  gap not met by the current system and address a clear mission need.

In recent years, DHS has canceled major acquisitions that we previously  found could have been more rigorous in their test design or execution,  including Gen-3. The nation’s ability to detect threats against its security  requires judicious use of resources directed toward systems whose  capabilities can be demonstrated. Applying lessons learned from the  Phase I testing of Gen-3 candidate technologies, as well as incorporating  the best practices we identified, may help enable DHS to mitigate risk in  future acquisitions for these types of threat detection technologies.  Specifically, DHS could apply them to the BioWatch program once  informed decisions have been made regarding upgrades or  enhancements to Gen-2.

Furthermore, DHS officials have continued to express interest in an  autonomous detection capability as a possible upgrade or enhancement  to Gen-2. If DHS were to pursue an autonomous detection system in the  near future, PCR would be the most mature technology available.  However, the extent to which the potential benefits of such a system  would materialize is uncertain, because of uncertainty in the assumptions  upon which these benefits depend. Additionally, pursuit of such a system  faces several likely challenges. Understanding the inherent challenges to  faster detection and contextualizing the benefits of autonomous detection  technologies will help decision makers make informed decisions  regarding use of limited resources. BioWatch is just one biosurveillance  activity used to detect potential biological threats to our national security,  and as we have previously reported, because the nation does not have  unlimited resources to protect the nation from every conceivable threat, it  must make risk-informed decisions regarding its homeland security  approaches and strategies. In July 2012, the White House released the  National Strategy for Biosurveillance to describe the U.S. government’s  approach to strengthening biosurveillance, but it is too soon to tell what  effect the strategy and corresponding implementation plan may have on  determining resource allocation priorities across the interagency. As  some Gen-2 equipment reaches the end of its lifecycle, DHS will need to  make decisions about investing in the future of the BioWatch program.  DHS initiated the BioWatch program in 2003 to address the perceived  threat at the time. Since then, numerous Bioterrorism Risk Assessments  have been issued, but these have been criticized for the methodology,  and none has been issued in the last 5 years. Consequently, as the  National Academies has noted, there is considerable uncertainty about  the likelihood and magnitude of a biological attack. Investment decisions  about the future of BioWatch should be guided by the agreed-upon  priorities of the various stakeholders within the biosurveillance community  to help ensure investments address the current threats posed by  biological hazards.

section_title: Recommendations for Executive Action
paragraphs: To help ensure that biosurveillance-related funding is directed to  programs that can demonstrate their intended capabilities, and to help  ensure sufficient information is known about the current Gen-2 system to  make informed cost-benefit decisions about possible upgrades and  enhancements to the system, the Secretary of Homeland Security should  direct the Assistant Secretary for Health Affairs and other relevant officials  within the Department to not pursue upgrades or enhancements to the  current BioWatch system until OHA: establishes technical performance requirements, including limits of  detection, necessary for a biodetection system to meet a clearly  defined operational objective for the BioWatch program by detecting  attacks of defined types and sizes with specified probabilities; assesses the Gen-2 system against these performance requirements  to reliably establish its capabilities; and produces a full accounting of statistical and other uncertainties and  limitations in what is known about the system’s capability to meet its  operational objectives.

To help reduce the risk of acquiring immature detection technologies, we  recommend that the Secretary of Homeland Security direct the Assistant  Secretary for Health Affairs, in coordination with the Under Secretary for  Science and Technology, to use the best practices outlined in this report  to inform test and evaluation actions for any future upgrades or changes  to technology for BioWatch.

section_title: Agency Comments and Our Evaluation
paragraphs: In written comments provided in response to our draft report, DHS  concurred with our recommendations and described actions the agency is  taking to address them. DHS also provided technical comments, which  we incorporated as appropriate. DOE provided technical comments,  which we incorporated as appropriate. CDC and DOD reviewed the draft  report and provided no comments. DHS’s written comments are  reproduced in full in appendix IV of this report.

DHS concurred with our recommendation to establish technical  performance requirements, including limits of detection, necessary for a  biodetection system to meet a clearly defined operational objective for the  BioWatch program by detecting attacks of defined types and sizes with  specified probabilities. DHS stated the BioWatch program has already  completed a series of tests that establish the performance and  capabilities of currently deployed technologies and provide baseline  performance requirements for any future technological improvements.  DHS also stated the BioWatch program will consider including additional  measures of system performance, such as probability of detection, to  augment and validate the system’s ability to detect attacks, pending  available resources and at a time yet to be determined.

However, using existing test results as a baseline for future technological  improvements provides no information about the current—or any future— system’s ability to meet a clearly defined operational objective. DHS  should first establish requirements for the current system, which will  enable DHS to assess its system performance measures, such as  sensitivity, against its stated mission goal: to detect attacks causing  10,000 casualties. Without establishing such performance requirements,  the agency does not know what the existing test results mean for the  system’s ability to detect attacks, and thus cannot establish the benefits  of any future improvements. Further, DHS mentioned using additional  system performance measures to augment and validate the system’s  capability. We emphasize that the program’s current preferred measure of  system performance, fraction of population protected (Fp), does not have  a clear linkage to the system’s operational objective. What is needed is  a measure that directly supports conclusions about the system’s ability to  meet its objective by detecting attacks of defined types and sizes.

DHS concurred with our recommendation to assess the Gen-2 system  against the performance requirements described above to reliably  establish its capabilities, and stated that the results of the testing and  evaluation events referred to above have already been incorporated into  existing modeling and simulation studies. DHS also stated, however, that  should a significant difference between two performance measures—Fp  and probability of detection (Pd)—be observed, the BioWatch program  would consider additional modeling and simulation studies to determine  the performance capabilities of the deployed Gen-2 BioWatch system.

While DHS’s response suggests that it has largely met this  recommendation already by having tested the system and incorporating  the test results into modeling and simulation studies, this conflicts with  what we have been told by BioWatch program officials. These officials  told us that they have not commissioned or produced an analysis in which  the best available test results have been combined with modeling and  simulation to reach specific conclusions about the system’s ability to  detect attacks of defined types and sizes. As we detailed in the report,  modeling and simulation studies commissioned by DHS either considered  ranges of hypothetical values for the system’s sensitivity or else involved  old test results, based on an earlier version of the system, for just one of  the BioWatch threat agents. Furthermore, we identified important  limitations in the tests DHS has conducted that could be addressed  through a more systematic approach to reducing risk and uncertainty in  what is known about the system’s capabilities when deployed in a real- world environment. While it is true that the system cannot be tested  directly by releasing live biothreat agents in the environments where  BioWatch is deployed, both the National Research Council and subject  matter experts with whom we spoke identified methods by which the  system can be tested and its performance characteristics estimated in  more realistic environments.

DHS concurred with our recommendation to produce a full accounting of  statistical and other uncertainties and limitations in what is known about  the system’s capability to meet its operational objectives. DHS stated it  already has sufficient understanding of the statistical uncertainties and  limitations associated with testing and modeling of the BioWatch system.  However, DHS also agreed that there is value in consolidating this  information into a single, comprehensive document and plans to do so by  April 30, 2016.

As described in the report, DHS does not have a sufficiently  comprehensive accounting of the uncertainties and limitations in what is  known about the system’s capabilities. A comprehensive analysis of  uncertainties and limitations should account for how such uncertainties  and limitations affect the key outcome: the system’s ability to meet its  operational objective by detecting attacks of defined types and sizes.  Statistical uncertainties should be represented with clearly defined  confidence intervals; for uncertainties that are difficult to quantify, such as  uncertainties associated with testing in chambers rather than operational  environments, the judgments of subject matter experts may be useful.  This full accounting of uncertainties and limitations should be provided to  administration and congressional decision makers so they better  understand the precision in what is known about the system’s capabilities  in an operational context. Decision makers should be able to use this  information not only when comparing the costs of the current system to  the benefits it may provide, but also when weighing decisions about  proposed upgrades or enhancements to the system.

DHS concurred with our recommendation to use the best practices we  outline in the report to inform test and evaluation actions for any future  upgrades or changes to technology for BioWatch. DHS stated that  changes to BioWatch will adhere to new DHS acquisition guidance that  incorporates the best practices outlined in our report.

DHS’s reference to new acquisition guidance is to DHS-wide guidance  that was issued in 2010, after DHS began testing the Gen-3 technology.  This guidance includes additional detail on factors to consider when  planning and testing new acquisitions and addresses many of the  practices described within this report. However, when it comes to  ensuring the acquisition will not only meet technical requirements but also  perform as intended in an operational environment, we believe more  robust testing earlier in the acquisition to test resilience can help reduce  the risk of acquiring immature technologies. This is especially important  for a system like BioWatch, which cannot be fully tested in an operational  environment. While we see proper implementation of DHS’s updated  acquisition guidance as a positive step towards addressing our  recommendation, as we reported in April 2015, DHS’s Director of  Operational Test and Evaluation expressed interest in becoming more  involved in testing earlier in the development process. Therefore, we  believe the lessons learned on Gen-3 testing and full adoption of testing  practices aimed at establishing the operational performance of a system  earlier in the acquisition should also be considered to help inform future  DHS decisions.

While DHS concurred with the three parts of our first recommendation,  the agency did not agree with key findings that led to these  recommendations; therefore, it is important to address parts of their  response for clarification.

DHS took exception to our conclusion that it has not defined technical  performance requirements that would link test results to conclusions  about the types and sizes of attack that the Gen-2 system could reliably  detect. DHS stated it uses the metric called fraction of population covered  (Fp) to make this linkage. However, when asked about this directly,  agency officials declined to explain how specific values of Fp would  enable DHS to conclude what types and sizes of attack the system can  detect. Furthermore, officials said they have not commissioned or  produced an analysis in which the best available test results are used to  calculate Fp values and draw conclusions about the system’s ability to  detect attacks of defined types and sizes. How a given value of Fp would  provide information about the types and sizes of attacks BioWatch Gen-2  can detect remains uncertain, and how Fp relates to the probability of  detecting attacks large enough to cause 10,000 casualties—DHS’s stated  objective for the BioWatch program—remains unclear. As we note in this  report, we recognize that Fp is a useful metric for certain purposes, but it  does not directly support conclusions that align with the BioWatch  operational objective.

DHS stated that it disagreed with the conclusion that the BioWatch  Program does not incorporate empirical data gathered on the current  Gen-2 system to inform modeling and simulation studies. However, DHS  incorrectly attributed this conclusion to us. We did not state that DHS did  not use any empirical data to inform their modeling and simulation  studies. We stated that (1) the modeling and simulation studies did not  incorporate specific, best available test results (for example, particular  estimates of the system’s limits of detection) to draw specific conclusions  about the BioWatch Gen-2 system’s capability to detect attacks of defined  types and sizes, and (2) the modeling and simulation studies did not  incorporate uncertainties in the empirical test results that are important for  understanding the precision or confidence in the modeling and simulation  results.

Finally, DHS acknowledged the evolving threat of bioterrorism and its  continued commitment to following DHS-wide acquisition policy for any  future upgrade or enhancement to the current BioWatch system.  Analogous to what we reported in 2012 regarding the Gen-3 acquisition,  by ensuring any future upgrades or enhancements to the BioWatch  system align with the earliest steps in DHS’s acquisition process, such as  being grounded in a justified mission need, and reflect a systematic  analysis of costs, benefits, and risks, DHS can gain assurance that it is  pursuing an optimal solution. Because, as DHS stated, the threat of  bioterrorism continues to evolve, and because the last full Bioterrorism  Risk Assessment (BTRA) was issued in 2010, it will be important for DHS  to demonstrate that any proposed upgrades or enhancement address the  threat posed by the intentional release of select aerosolized biological  agents at the time upgrades are considered.

As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the Secretaries of  Homeland Security, Health Human and Services, Defense, and        Energy; and interested congressional committees. The report is also  available at no charge on GAO’s website at http://www.gao.gov.

If you or your staff members have any questions about this report, please  contact Tim Persons at (202) 512-6412 or personst@gao.gov or Chris  Currie at (404) 679-1875 or curriec@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix V.

section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: The objectives of this report were to discuss: (1) the extent to which the  Department of Homeland Security (DHS) has assessed the technical  capability of the currently deployed system (Gen-2) to detect a biological  attack; (2) the extent to which DHS adhered to best practices for  developmental testing during Gen-3 Phase I, and what lessons can be  learned; and (3) the most mature technology for an autonomous detection  system, as well as what the potential benefits and likely challenges would  be if DHS were to pursue an autonomous detection system for the  BioWatch program in the near future.

To determine the extent to which DHS has assessed the technical  capability of the Gen-2 system to detect an attack, we reviewed and  analyzed test reports and other agency and agency-commissioned  documents containing information on the design, development,  deployment, and technical performance characteristics of the system. We  also reviewed reports of modeling and simulation studies, conducted by  Department of Energy (DOE) national laboratories for DHS, that analyzed  the performance and capabilities of the system. We interviewed DHS  officials from the BioWatch Program Office and from the Science and  Technology Directorate (S&T) who had knowledge of the history of the  program, the Gen-2 technology and changes that had been made to the  technology over time, and the tests and studies that had been conducted  on the Gen-2 system’s technical capabilities. We also interviewed officials  and researchers who conducted or were familiar with the tests and the  modeling and simulation studies; these included officials and researchers  at Dugway Proving Ground, Sandia National Laboratories, Lawrence  Livermore National Laboratory, and Los Alamos National Laboratory. In  interviews with researchers who had conducted tests and studies, we  questioned them about the scope and purposes of their work; the  methods they had used; conclusions drawn, as well as any caveats on  those conclusions; and the strengths and limitations of the tests and  studies. We conducted a site visit to Dugway Proving Ground and saw  facilities and equipment that had been used to test the Gen-2 system, as  well as facilities under construction that could potentially be used for  future testing of the BioWatch system. To assess the strengths and  limitations of tests and studies of the Gen-2 system, we used (1) a  framework for testing and evaluation of biodetection systems developed  by the National Research Council, (2) leading practices in risk analysis  and cost-benefit analysis, and (3) judgment of internal (GAO) and  selected external experts in the fields of engineering, aerobiology,  microbiology, and testing and evaluation of biodetection systems. To  gather information on the field of biodetection and the strengths and  limitations of alternative technologies, we attended two conferences on  biodetection technologies.

To determine whether DHS’s actions during Gen-3 Phase I adhered to  best practices for developmental testing and to identify lessons that could  be learned, we reviewed the best practices previously developed in  conjunction with the National Academes to assess their appropriateness  to our review. We consulted with GAO specialists familiar with the best  practices for developmental testing to discuss their proper application. We  determined the practices that could be applied to Gen-3 Phase I testing,  as the testing was developmental in nature and presented opportunities  for DHS to de-risk the Gen-3 acquisition, which is the intent of the  practices—to de-risk acquisitions of binary threat detection technologies  by the government. We analyzed Gen-3 Phase I acquisition and testing  documents, such as the test and evaluation master plans, individual test  plans and results, and the operational requirements documents. We  analyzed other DHS documentation on lessons learned, including the  Post Implementation Review assessment, in which DHS identified its own  lessons learned on the Gen-3 acquisition. We reviewed the acquisition  decision memorandum on the cancellation of the Gen-3 acquisition.

We interviewed DHS officials in the BioWatch Program Office, the Office  of the Director of Test and Evaluation at the Science and Technology  Directorate, and officials at the national laboratories and Department of  Defense (DOD) test agencies who were familiar with the testing  performed during Gen-3 Phase I. We collected information from these  officials on DHS’s actions and decisions during Phase I testing and  compared that with the recommended actions outlined in the best  practices for developmental testing. We also compared the steps outlined  in the test planning documents with the recommended steps described in  the best practices. We consulted with internal and external experts on our  assessment of DHS’s actions and decisions compared with the best  practices and acquisitions more broadly. We reviewed prior GAO reports  on the Gen-3 acquisition and the biosurveillance enterprise. We also  reviewed prior GAO work on other DHS acquisitions that met challenges  during early phases of testing to draw comparisons with other DHS  acquisitions that may have benefited from more robust testing guidance.

To develop the best practices for developmental testing of binary threat  detection systems, we conducted a 1-day meeting on June 4, 2013, with  12 experts we selected with assistance from the National Academies.  These experts were from academia, industry, and the federal government  and had experience in developmental testing methodologies, binary  threat detection systems, automatic target recognition, and advanced  imaging technologies, from fields that included homeland security,  defense, and standards development. To identify the experts, the  National Academies considered experts with previous experience on  appropriate National Academy studies, requested suggestions from the  members of the National Academies’ National Materials and  Manufacturing Board and the Computer Sciences and  Telecommunications Board, searched internal databases and the Web,  and contacted other relevant individuals for recommendations. We  facilitated the experts’ identification of best practices with pre-meeting  interviews, structured questioning during the meeting, and post-meeting  expert voting and ranking procedures. According to the experts, the best  practices apply to the process of developmental testing of binary threat  detection systems; they also apply if the system is commercial-off-the- shelf (COTS), modified COTS, or newly developed for a specific threat  detection purpose being created by a vendor or the government.

To identify the most mature technology for autonomous detection, we  reviewed a report of a 2013 workshop conducted by the National  Academies that assessed the state of technologies that are potentially  suitable for autonomous detection for the BioWatch program. We also  interviewed officials at the Centers for Disease Control and Prevention,  the Department of Homeland Security’s Office of Health Affairs, Lawrence  Livermore National Laboratory, and the Department of Defense who were  familiar with BioWatch and biodetection technologies to gather their views  on the state of autonomous detection technology. A conclusion of the  National Academies workshop held in 2013 was that the polymerase  chain reaction (PCR) was the most mature technology suitable for  autonomous detection for BioWatch. As a check for any more recent  developments that might affect this conclusion, we performed a literature  review of journals and conference proceedings published since 2012 to  identify any technologies potentially more mature than PCR based on the  following criteria:  1. whether the detection technology is specified, meaning the technology is defined and not just referred to as biodetection or detection technology; 2. capacity to detect at least bacteria and virus; 6. having both indoor and outdoor performance capabilities in realistic 7. ability to detect independently (standalone); 8. technology readiness level (TRL) of 6 or higher, if reported; 9. sampled from aerosols/air; 10. whether the technology is used for disease surveillance or modeling instead of pathogen detection; and 11. whether the technology depends on, or is a variant of, PCR.

We excluded press releases and news articles, studies that did not  include sufficient detail for evaluating technological detection capability,  technologies that were intended for non-aerosol detection (such as for  food or clinical specimen testing), or technologies that were intended to  be used alongside other technologies for detection (for example, used to  supplement or verify a finding, or used as a trigger warning system). Our  literature review was not intended to be a comprehensive examination of  all technologies that might possibly be applied to BioWatch, but rather a  supplement to the National Academies workshop report and a check to  help ensure that the conclusions of that workshop were not affected by  more recent developments in the field.

To assess the potential benefits and likely challenges of autonomous  detection, we analyzed reports published by the Sandia National  Laboratories, as well as our prior work on the Gen-3 BioWatch system.  We performed a literature review for models of how response timing to a  positive detection of agent release may affect response effectiveness, in  terms of lives saved. We searched for models published in the last 12  years, a range that was designed to cover work done following the  anthrax attacks of 2001. We interviewed officials at the Centers for  Disease Control and Prevention, the Department of Homeland Security’s  Office of Health Affairs, and Lawrence Livermore National Laboratory to  gather their views on the potential benefits and likely challenges of  autonomous detection in the near future, which we defined as the next 5  years. Additionally, we reviewed Gen-3 BioWatch testing reports to  identify likely challenges to autonomous detection systems.

To determine the potential cost saving benefits of an autonomous  detection system, we analyzed cost data provided by DHS. The agency  provided annual operation and maintenance costs and total annual  program costs for the current BioWatch system under the assumption that  detection cycles would be increased to three per day (up from once per  day, which is the current practice in most jurisdictions), as well as total  annual costs for running a hypothetical autonomous detection system  with six to eight detection cycles per day, with comparable coverage. The  total annual cost for operating the current BioWatch system was  calculated by dividing the annual operation and maintenance costs by  three but keeping the remaining costs constant under the assumption that  non-operation and maintenance costs remain the same.

Our analysis of potential benefits and likely challenges represent key  ones that were identified by the sources listed above, and is not intended  to be comprehensive. In particular we did not assess or mention  characteristics that were difficult or impossible to meaningfully discuss  within the context of this report (for example, deterrent effects of a  biodetection system, or finding qualified personnel to hire). For benefits,  we focused primarily on reports published by Sandia National  Laboratories because they focused most directly on the BioWatch  program.

To help collect and analyze information for all three of our research  objectives—and to help ensure the technical accuracy of our work—we  consulted with subject matter experts under contract with GAO in the  fields of aerobiology, microbiology, and biodetection.

We conducted this performance audit from December 2013 to October  2015 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.

section_title: Appendix II: The Department of Homeland Security Has Made Adjustments to the Gen-2 System Designed to Reduce False Positives
paragraphs: In the Gen-2 system, if the polymerase chain reaction (PCR) assays used  in both the screening step and the verification step yield positive results,  suggesting the presence of a BioWatch threat agent, then a BioWatch  Actionable Result (BAR) is declared. From the program’s inception in  2003 through 2014, there were 149 BARs. None was found to be  associated with the release of a biothreat agent, and these BARs have  been termed false positives by Centers for Disease Control and  Prevention (CDC) officials and others.

We found that all of the BARs from 2003 through 2014 were associated  with PCR assays for two biothreat agents: Brucella and Francisella  tularensis. The majority were associated with the assays for Francisella  tularensis, and these have been attributed to detections of a non-disease- causing relative, or near-neighbor, of the Francisella tularensis bacterium  that occurs naturally in the environment. Expert stakeholders told us that,  before BioWatch, scientists had no reason or occasion to assess the  presence or prevalence of these naturally occurring, non-disease-causing  near-neighbors.

Department of Homeland Security (DHS) officials and other stakeholders  said several adjustments were made to the Gen-2 system in 2011 and  2012 to reduce the number of false positives. In August of 2011, a stricter  criterion for deciding that PCR assays revealed the presence of biothreat  agents was adopted. Between November of 2011 and December of  2012, BioWatch adopted new PCR assays for the screening step of  analysis. Previously, assays developed by CDC for use in its Laboratory  Response Network (LRN) had been used for both screening and  verification. The new assays were from the Department of Defense’s  (DOD) Critical Reagents Program (CRP) and were designed to look for  different genetic signatures of the BioWatch threat agents. In general,  assays designed to detect greater numbers of unique genetic signatures  will provide greater specificity—that is, greater ability to distinguish  between the agents of interest and other, genetically similar agents. In  December of 2012, BioWatch adopted new PCR assays specifically  intended to distinguish between disease-causing and non-disease- causing species of Francisella; under the new analysis protocol, these  new assays are run in the verification step if the screening step returned a  positive result for Francisella.

Another adjustment to the system was not made in order to reduce the  number of false positives but likely had this effect. In March, 2008, the  PCR assays for Brucella were discontinued. According to BioWatch  officials, this was because CDC had reclassified Brucella into a lower- threat category. Some of the BARs prior to March of 2008 were  associated with the PCR assays for Brucella, and such BARs were no  longer possible after this agent was discontinued as a BioWatch threat  agent.

The annual number of BARs decreased during the years when the  adjustments designed to reduce false positives were made, and after the  final adjustment (the adoption of the new Francisella assays) there were  no BARs through 2014 (see fig. 6). This decrease is consistent with the  possibility that the adjustments have provided greater specificity, as  intended; however, there was large, unexplained variability in the annual  numbers of BARs in earlier years, and we did not conduct an independent  analysis to assess the extent to which the decrease since 2010 might be  associated with the specific adjustments DHS made to the system.

According to a recent report by the National Academies, there is no once- and-for-all solution to the problem of false positives for a biodetection  system based on PCR assays. This is because biological agents  continue to evolve, and new strains and near-neighbors continue to arise.  Consequently, a biodetection system based on PCR assays, such as  BioWatch, will likely require ongoing adjustments to manage or prevent  false positives, and the National Academies recommended that the  BioWatch program continue to test its assays against panels of near- neighbors as these panels are reviewed and updated over time.

section_title: Appendix III: Best Practices for Developmental Testing
paragraphs: In 2013, in collaboration with the National Academies, we identified eight  best practices for developmental testing of threat detection systems.  According to the experts who deliberated on the best practices, the  practices apply to the process of developmental testing of binary threat  detection systems; they also apply if the system is commercial-off-the- shelf (COTS), modified COTS, or newly developed for a specific threat  detection purpose being created by a vendor or the government. For  additional information on the methods used to determine the best  practices, see appendix I.

The identified eight best practices for developmental testing of binary  threat detection systems are described below, often using the context of  the BioWatch program.
subsections: section_title: Practice 1: Ensure that accountability and engagement in developmental testing are commensurate with the amount of risk accepted.
paragraphs: According to experts, the level of government involvement in the  development of a given system should be commensurate with the level of  risk it is accepting. Risk needs to be assessed when the system is  COTS, modified COTS, or a newly developed system, because even with  commercial items, significant modifications may be needed. Experts also  told us that relying solely on the vendor and holding the vendor  responsible for any problem that arises is not consistent with the  accountability and engagement required for acquisitions where the  government is accepting significant risk. Further, an understanding of the  technical risk associated with the development of a given system is  important, or in the case of the purchase of a commercial item,  understanding the modifications needed to an existing system to  accommodate government-specific needs, is important.

section_title: Practice 2: Include representatives from the user community in design and developmental testing teams to ensure acceptance of the system by the user community.
paragraphs: Design and developmental testing teams need to understand the needs,  concerns, and capabilities of the user community or they run the risk of  designing and testing a system that, in the case of autonomous biological  detection systems, (1) operators may have difficulty operating, or (2)  decision makers may have difficulty with when interpreting results.  According to experts, the user community may have suggestions that  could improve the system or make the developmental tests more realistic.  Distinct from subject matter experts that monitor developmental testing,  these representatives are integral parts of the design and developmental  testing teams. The role of these team members is to make sure that the  needs, concerns, and capabilities of the user community are considered  throughout design and developmental testing efforts.

section_title: Practice 3: Take a systems engineering view of the system prior to entering into any developmental test.
paragraphs: According to experts, to take a systems engineering view of a system, the  tester must understand the boundaries of what it is being tested prior to  developmental testing. For example, would DHS plan to test just the  assays or analytical components of the Gen-3 candidate systems or  would it plan to test the whole end-to-end system (i.e., collection,  extraction, analysis, and communication of result), and was that plan  communicated in the test and evaluation master plan (TEMP)? This is  critical, since different system boundaries impose different testing  methods and constraints.

section_title: Practice 4: Use statistical experimental design methodology to establish a solid foundation for developmental testing.
paragraphs: According to experts, use of statistical experimental design methodology  ensures that a test has been designed with a clear understanding of goals  and acceptable limitations, that the test is clearly documented, and that  the test results are rigorously analyzed. Experts said statistical  experimental design is the tool used to define the test goals, limitations,  and procedures, and establishes a detailed plan for conducting the  experiment. Further, experts stated that the creation and use of an  appropriate model against which system performance can be evaluated is  fundamentally important when establishing the statistical experimental  design. According to experts, the system’s operational objectives and  user’s needs should be identified before designing the experiment, and  uncertainties should be characterized and reported with all system  performance estimates. Experts told us that well-chosen statistical  experimental designs maximize the amount of information that can be  obtained for a given amount of experimental effort.

section_title: Practice 5: Measure and characterize system performance with established procedures, methods, and metrics.
paragraphs: According to experts, binary threat detection systems have an established  body of statistically based methods and procedures used to evaluate and  characterize them. Further, experts stated it is important to use certain  objective metrics to characterize system performance.

section_title: Practice 6: Test to build in resilience, especially in the development stages.
paragraphs: According to experts, one way to improve resilience is to uncover  vulnerabilities as early as possible through rigorous and comprehensive  testing of the system against various scenarios. For example, the  BioWatch system operates in a number of different environmental  settings with varying contaminants. Settings vary from warm to cold  climates, dry to wet climates, and indoor and outdoor settings. The  BioWatch sensors might be exposed to dust, metallic dust, smoke, and  diesel exhaust in indoor environments, as well as to rain, fog, snow, ice,  wind, salt spray, sand, and pollen in outdoor environments. To the extent  possible, these potential contaminants should be part of the testing of a  detection system to help identify vulnerabilities to performance in these  environments.

According to experts, the further the system moves down the  development path, the more fixed the design becomes. Thus, when the  developmental testing team uncovers an error (i.e., the system failed a  test), it is increasingly expensive to fix. Any time there is a change in the  design, everything that worked before needs to be re-tested to make sure  the change did not undo something that already has been shown to work.  Therefore, according to experts, agencies should focus on building in  resilience during early and intermediate developmental testing so as to  minimize the number of hidden failures found in the later stages of  testing.

section_title: Practice 7: Use developmental tests to refine performance requirements.
paragraphs: According to experts, developmental testing should be viewed as a critical  tool in helping to refine performance requirements. Experts told us that a  meaningful performance requirement is one that not only is achievable  but also strives to maximize the fulfillment of a mission need—which in  the case of BioWatch might be the number of lives saved. While the  minimum required performance thresholds may be achievable, they may  fall short of the maximum achievable performance. Experts informed us  that the maximum achievable performance can be uncovered only by  understanding what the system is actually capable of doing through  comprehensive developmental testing that unrestrainedly explores the  performance boundaries of the system.

section_title: Practice 8: Engage in a continuous cycle of improvement by (1) conducting developmental testing, (2) conducting operational testing, and (3) incorporating lessons learned.
paragraphs: Experts told us that it is important to consider developmental testing and  operational testing as a continuum by defining developmental testing  broadly to cover, for example, operational test activities that traditionally  have been viewed as post-development, rather than artificially limiting the  development of a system to a fixed stage. Experts also said it is important  to use lessons learned on preceding tests to improve the probability of  success (proper system performance) on following tests and to use  lessons learned from test failures as feedback into the design process to  continuously improve system performance.

section_title: Appendix IV: Comments from the U.S. Department of Homeland Security

section_title: Appendix V: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts

section_title: Staff Acknowledgments
paragraphs: In addition to the individuals named above, Edward George (Assistant  Director), Sushil Sharma (Assistant Director), Russ Burnett, Kendall  Childers, Eric Hauswirth, Hayden Huang, Susanna Kuebler, Jack Melling,  Jeff Mohr, Rebecca Shea, and Katherine Trimble made key contributions  to this report.


Question-summary annotations: questions: question: What failures are there in the DHS's management of BioWatch Gen-2?
answer: The Department of Homeland Security (DHS) lacks reliable information about BioWatch Gen-2's technical capabilities to detect a biological attack and therefore lacks the basis for informed cost-benefit decisions about upgrades to the system.
child_questions: question: Why is there a lack of reliable information?
answer: DHS commissioned several tests of the technical performance characteristics of the current BioWatch Gen-2 system, but has not developed performance requirements that would enable it to interpret the test results and draw conclusions about the system's ability to detect attacks.

question: How has the DHS failed to define objectives?
answer: Although DHS officials said that the system can detect catastrophic attacks, which they define as attacks large enough to cause 10,000 casualties, they have not specified the performance requirements necessary to reliably meet this operational objective.

question: How has the DHS failed performance requirements?
answer: In the absence of performance requirements, DHS officials said computer modeling and simulation studies support their assertion. However, none of these studies were designed to incorporate test results from the Gen-2 system and comprehensively assess the system against the stated operational objective.
child_questions: question: How does the DHS fail to additionally analyze their results?
answer: Additionally, DHS has not prepared an analysis that combines the modeling and simulation studies with the specific Gen-2 test results to assess the system's capabilities to detect attacks.

question: How was the performance of Gen-2 evaluated?
answer: Finally, we found limitations and uncertainties in the four key tests of the Gen-2 system's performance.

question: Why was direct BioWatch testing impossible?
answer: Because it is not possible to test the BioWatch system directly by releasing live biothreat agents into the air in operational environments, DHS relied on chamber testing and the use of simulated biothreat agents, which limit the applicability of the results.
child_questions: question: How does this testing fail to be sufficient?
answer: These limitations underscore the need for a full accounting of statistical and other uncertainties, without which decision makers lack a full understanding of the Gen-2 system's capability to detect attacks of defined types and sizes and cannot make informed decisions about the value of proposed upgrades.

questions: question: How did DHS practice align with GAO recommendations?
answer: The actions and decisions DHS made regarding the acquisition and testing of a proposed next generation of BioWatch (Gen-3) partially aligned with best practices GAO previously identified for developmental testing of threat detection systems.

question: What do best practices indicate?
answer: For example, best practices indicate that resilience testing, or testing for vulnerabilities, can help uncover problems early.
child_questions: question: How did the DHS use best practices in Gen-3?
answer: While DHS took steps to help build resilience into the Gen-3 testing, future testing could be improved by using more rigorous methods to help predict performance in different operational environments.

question: How did Gen-3 assist in review of the Gen-2?
answer: DHS canceled the Gen-3 acquisition in April 2014, but GAO identified lessons DHS could learn by applying these best practices to the proposed Gen-2 upgrades.

questions: question: What is the best technology to detect bio attacks?
answer: According to experts and practitioners, the polymerase chain reaction (PCR), which detects genetic signatures of biothreat agents, is the most mature technology to use for an autonomous detection system.

question: How is the DHS planning to use PCR?
answer: DHS is considering autonomous detection as an upgrade to Gen-2, because according to DHS, it may provide benefits such as reduction in casualties or clean-up costs.
child_questions: question: What are the benefits of this use?
answer: But the extent of these benefits is uncertain because of several assumptions, such as the speed of response after a detection, that are largely outside of DHS's control. As a result, the effectiveness of the responseâ€”and the number of lives that could be savedâ€”is uncertain.

question: What are some challenges of PCR use?
answer: As a result, the effectiveness of the responseâ€”and the number of lives that could be savedâ€”is uncertain. Further, an autonomous detection system must address several likely challenges, including minimizing possible false positive readings, meeting sensitivity requirements, and securing information technology networks.

questions: question: What is BioWatch?
answer: DHS's BioWatch program aims to provide early indication of an aerosolized biological weapon attack.

question: How has the DHS attempted to detect bio attacks?
answer: Until April 2014, DHS pursued a next-generation autonomous detection technology (Gen-3), which aimed to enable collection and analysis of air samples in less than 6 hours, unlike the current system (Gen-2), which requires manual intervention and can take up to 36 hours to detect the presence of biological pathogens.
child_questions: question: How is the DHS currently attempting to improve these systems?
answer: DHS is taking steps to address the capability gap that resulted from the cancellation of Gen-3 by exploring other technology upgrades and improvements to the Gen-2 system.

questions: question: What was the GAO asked to review?
answer: GAO was asked to review (1) the technical capabilities of the currently deployed BioWatch system, (2) the Gen-3 testing effort, and (3) characteristics of autonomous detection as a possible option to replace the current BioWatch system.
child_questions: question: What information was collected for this review?
answer: GAO analyzed key program documents, including test plans, test results, and modeling studies.

question: What did the GAO assess for their review?
answer: GAO assessed Gen-3 testing against best practices, reviewed relevant literature, and discussed the BioWatch program and testing efforts with key agency officials and national laboratories staff.