BioWatch program faces GAO, congressional scrutiny

Disclosure: The University of Minnesota's Center for Infectious Disease Research and Policy, which publishes CIDRAP News, has produced training programs and materials for the BioWatch program. The news team has no involvement in the center's BioWatch work.

Sep 13, 2012 (CIDRAP News) – The federal BioWatch program came under heavy scrutiny in Congress today, as two subcommittees questioned officials in the wake of a report saying that the Department of Homeland Security (DHS) failed to fully analyze needs, costs, and benefits before moving forward with plans for costly new biosurveillance technology.

The General Accountability Office (GAO), Congress's auditing arm, in a report released yesterday, raised questions about the procedures DHS used in developing its "Generation 3" (Gen 3) technology for detecting dangerous airborne pathogens such as anthrax. The GAO said the agency did not thoroughly evaluate the need for Gen 3 or carefully assess other approaches.

BioWatch currently has about 600 "Gen 2" air sampling stations in 30 large cities, with filters that trap airborne particles. The filters are manually collected daily and tested for pathogens that could suggest a bioterrorist attack.

Gen 3 sampling equipment, if it works as intended, would test samples automatically and provide results every 4 to 6 hours, versus 12 to 36 hours for Gen 2 equipment. But the technology is expensive, and it still faces significant scientific and technical hurdles, the National Research Council said in a 2011 report. The full "life-cycle" cost of Gen 3 is currently estimated at $5.8 billion.

"Our work showed that DHS does not have reasonable assurance that the solution it has been pursuing warrants investment of limited resources and that it represents an optimal solution," the GAO said in its report. "We believe it is possible that an earnest effort to reconsider the Gen-3 mission needs and alternatives would result in a different plan and course of action than the current effort."

The GAO is recommending that DHS officials "reevaluate the mission need and systematically analyze alternatives based on cost-benefit and risk information," and then revise its acquisition documents to reflect any changes in performance, cost, and scheduling data generated by the new evaluation.

US House members echoed the GAO concerns at this afternoon's hearing convened by two subcommittees that deal with security issues.

"My concern is whether this very expensive acquisition will be properly handled," said Rep. Gus Bilirakis, R-Fla., chair of the Homeland Security Subcommittee on Emergency Preparedness, Response, and Communications. He said DHS has already spent $100 million on Gen 3, the full deployment of which was originally set for 2016 but now is scheduled for 2022.

DHS's position, as described in the GAO report and stated by officials at the hearing, is that it agrees with the GAO recommendations, but that it can continue with its Gen 3 acquisition process while the reevaluation is being done.

"DHS concurs with the GAO recommendations, and we're moving forward in a way that ensures best practices compliance," said Alexander Garza, MD, MPH, DHS's chief medical officer, at the hearing.

"We're doing all the documentation for acquisition, cost-benefit [analysis], mission needs statement," he said. "During that time we didn't want to delay the technical development. So there's not going to be any contracts let or performance testing done during that time period. At the end of the day, we're going to be aligned with exactly what GAO is saying."

According to the GAO report, DHS officials informed the GAO that on Aug 16 (2012), they directed the BioWatch program to prepare an updated "Analysis of Alternatives and Concept of Operations," but they did not explain how they would reevaluate the mission need.

The DHS's plan to pursue testing of Gen 3 while agreeing to reconsider whether it is an appropriate approach "raises questions about whether the department plans to systematically and objectively reevaluate the mission need and alternatives for fulfilling that need," the GAO says at the end of the report.

While agreeing that the need for Gen 3 and the feasibility of other approaches need reconsideration, Garza defended the proposed system, calling it a "game changer."

"The true benefit it brings to the nation is decreasing the time to detection from 12 to 36 hours to 4 to 6 hours," which would save lives in the case of an anthrax attack, he said. "Time is the currency we barter with when it comes to bioterrorism. The quicker we can get pills in mouths, the more lives we save."

Garza also reminded the subcommittees that Gen 3 technology can be used indoors, which is not true of Gen 2. "Not only are we improving timeliness, we're also able to go inside, where we think some of the threat will be emanating from," he said.

He also defended the current monitoring system, which, according to the GAO report, has generated more than 100 pathogen detections, known as BioWatch actionable results (BARs), since 2003. Those incidents, which all were found to be triggered by naturally occurring microorganisms, have posed tough challenges for the state and local public health officials who have had to deal with them.

BARs have been branded as "false alarms" in press reports. But Garza said today, "A BAR is a detection of targeted DNA. It's never been promoted or described as a detection of a bioterrorist attack." He said a BAR is "a piece of data," and humans decide what it means.

BioWatch got some support today from one state health official, Frances Phillips, RN, MHA, deputy secretary of public health services for the Maryland Department of Health and Mental Hygiene.

Overall, she said, BioWatch has been beneficial for Maryland's biosurveillance capabilities, and each BAR has led to improvements in response protocols.

"Our state lab has been supported by DHS with regard to salaries, supplies, and administrative expenses," she said. "BioWatch has helped Maryland enhance its ability to identify and respond to a wide range of threats."

The general thrust of the GAO report is that the decision to move toward Gen 3 was made years ago and that studies of the need and possible alternatives were done with an eye toward supporting that predetermined conclusion.

At the hearing, William O. Jenkins, Jr, PhD, director of homeland security and justice issues at the GAO, said, "In general what we found is that there had been an assumption from very early on, before 2008, that automating Gen 2 was the way go to, and all the decisions sort of flowed from that assumption. So there was never a real refreshing new look at the mission needs statement."

The GAO estimates that the total annual cost of operating Gen 3 would be about four times as high as the cost of operating Gen 2 ($363.6 million versus $86.6 million), though that is partly because of a planned increase in the number of detectors and the number of cities covered.

The GAO also says that the Gen 3 Analysis of Alternatives included no analysis of benefits, beyond the assumption that earlier detection will save lives and reduce economic losses. Further, DHS did not explore whether some approach other than wholesale installation of automated detectors might be more effective.

"Given the uncertainty related to the costs, benefits, and risk mitigation potential of Gen-3, DHS does not have reasonable assurance that the strategy of expanding and completely replacing the existing Gen-2 technology with an autonomous detection technology provides the most cost-effective solution," the report says.

See also:

GAO report (released Sep 12, but dated Sep 10)

House subcommittee hearing page

Hearing Webcast link

Garza's prepared testimony

Aug 17 CIDRAP News story "Public health officials respond to critique of BioWatch"

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