This page lists the most recent reports and testimonies related to influenza issued since October 2000. http://gao.gov/docsearch/featured/influenza.html Tue, 24 Nov 2009 16:15:50 -0500 GAO http://www.gao.gov/images/title_object.jpg http://www.gao.gov/ Feed provided by GAO. Click to visit. http://www.gao.gov/new.items/d108.pdf Concerns exist that a more severe pandemic outbreak than 2009's could cause large numbers of people staying home to increase their Internet use and overwhelm Internet providers' network capacities. Such network congestion could prevent staff from broker-dealers and other securities market participants from teleworking during a pandemic. The Department of Homeland Security (DHS) is responsible for ensuring that critical telecommunications infrastructure is protected. GAO was asked to examine a pandemic's impact on Internet congestion and what actions can be and are being taken to address it, the adequacy of securities market organizations' pandemic plans, and the Securities and Exchange Commission's (SEC) oversight of these efforts. GAO reviewed relevant studies, regulatory guidance and examinations, interviewed telecommunications providers and financial market participants, and analyzed pandemic plans for seven critical market organizations. Increased demand during a severe pandemic could exceed the capacities of Internet providers' access networks for residential users and interfere with teleworkers in the securities market and other sectors, according to a DHS study and providers. Private Internet providers have limited ability to prioritize traffic or take other actions that could assist critical teleworkers. Some actions, such as reducing customers' transmission speeds or blocking popular Web sites, could negatively impact e-commerce and require government authorization. However, DHS has not developed a strategy to address potential Internet congestion or worked with federal partners to ensure that sufficient authorities to act exist. It also has not assessed the feasibility of conducting a campaign to obtain public cooperation to reduce nonessential Internet use to relieve congestion. DHS also has not begun coordinating with other federal and private sector entities to assess other actions that could be taken or determine what authorities may be needed to act. Because the key securities exchanges and clearing organizations generally use proprietary networks that bypass the public Internet, their ability to execute and process trades should not be affected by any congestion. In analyzing seven critical market organizations, GAO found they had prepared pandemic plans that addressed key regulatory elements, including hygiene programs to minimize staff illness and continuing operations by spreading staff across geographic areas. However, not all had completed or documented analyses of whether they would have sufficient staff capable of carrying out critical activities if many of their employees were ill. Also, not all had developed alternatives to teleworking if congestion arises. SEC staff have been regularly examining market organizations' readiness, but could further reduce risk of disruptions by ensuring that these organizations prepare complete staffing analyses and teleworking alternatives. Mon, 26 Oct 2009 00:00:00 -0400 http://www.gao.gov/new.items/d091011t.pdf Since 1997, periodic GAO surveys indicate that overall, federal managers have more performance information available, but have not made greater use of this information for decision making. To understand the barriers and opportunities for more widespread use, GAO was asked to (1) examine key management practices in an agency in which managers' reported use of performance information has improved; (2) look at agencies with relatively low use of performance information and the factors that contribute to this condition; and (3) review the role the President and Congress can play in promoting a results-oriented and collaborative culture in the federal government. This testimony is primarily based on GAO's report, Results-Oriented Management: Strengthening Key Practices at FEMA and Interior Could Promote Greater Use of Performance Information, which is being released today. In this report, GAO made recommendations to the Departments of Homeland Security (DHS) and the Interior for improvements to key management practices to promote greater use of performance information at FEMA, the National Park Service, Bureau of Reclamation, as well as at Interior. Both DHS and Interior generally agreed with these recommendations. The testimony also draws from GAO's extensive prior work on the use of performance information and results-oriented management. GAO's prior work identified key management practices that can promote the use of performance information for decision making to improve results, including: demonstrating leadership commitment; aligning agency, program, and individual performance goals; improving the usefulness of performance information; building analytic capacity; and communicating performance information frequently and effectively. The experience of the Centers for Medicare & Medicaid Services (CMS) illustrates how strengthening these practices can help an agency increase its use of performance information. According to GAO's most recent 2007 survey of federal managers, the percentage of CMS managers reporting use of performance information for various management decisions increased by nearly 21 percentage points since 2000--one of the largest improvements among the agencies surveyed. CMS officials attributed this positive change to a number of the key practices, such as the agency's leaders communicating their commitment to using performance information to drive decision making. Conversely, the experiences of the Department of the Interior (Interior) and the Federal Emergency Management Agency (FEMA) within the Department of Homeland Security indicated that the absence of such commitment can discourage managers and their staff from using performance information. According to GAO's 2007 survey, Interior and FEMA ranked 27 and 28, respectively, out of 29 agencies in their reported use of performance information for various management functions. Based on further survey data analysis, reviews of planning, policy, and performance documents, and management interviews, GAO found that inconsistent application of key practices at FEMA and Interior--such as routine communication of how performance information influences decision making--contributed to their relatively low survey scores. While both FEMA and Interior have taken some promising steps to make their performance information both useful and used, these initiatives have thus far been limited. The President and Congress also have unique and critical roles to play by driving improved federal agency performance. By focusing attention on certain high-level goals and tracking agency performance, the President and the Office of Management and Budget (OMB) can send a message that using performance information is critical for achieving results and maximizing the return on federal funds invested. Through its oversight, Congress can also signal to agencies that results matter by articulating performance expectations for areas of concern and following up to ensure that performance goals are achieved. The President and Congress can also play a role in improving government performance in areas that require the concerted efforts of multiple agencies and programs to address, such as preparing for and responding to a pandemic influenza. A governmentwide strategic plan could support collaborative efforts by identifying long-term goals and the strategies needed to address crosscutting issues. Thu, 24 Sep 2009 00:00:00 -0400 http://www.gao.gov/new.items/d09574.pdf U.S. laboratories working with dangerous biological pathogens (commonly referred to as high-containment laboratories) have proliferated in recent years. As a result, the public is concerned about the oversight of these laboratories. The deliberate or accidental release of biological pathogens can have disastrous consequences. GAO was asked to determine (1) to what extent, and in what areas, the number of high-containment laboratories has increased in the United States, (2) which federal agency is responsible for tracking this expansion and determining the associated aggregate risks, and (3) lessons learned from highly publicized incidents at these laboratories and actions taken by the regulatory agencies. To carry out its work, GAO surveyed and interviewed federal agency officials, (including relevant intelligence community officials), consulted with experts in microbiology, reviewed literature, conducted site visits, and analyzed incidents at high-containment laboratories. The recent expansion of high-containment laboratories in the United Statesbegan in response to the need to develop medical countermeasures after the anthrax attacks in 2001. Understandably, the expansion initially lacked a clear, governmentwide coordinated strategy. In that emergency situation, the expansion was based on individual agency perceptions of the capacity their high-containment labs required as well as the availability of congressionally approved funding. Decisions to fund the construction of high-containment labs were made by multiple federal agencies in multiple budget cycles. Federal and state agencies, academia, and the private sector considered their individual requirements, but an assessment of national needs was lacking. Even now, after more than 7 years, GAO was unable to find any projections based on a governmentwide strategic evaluation of future capacity requirements set in light of existing capacity; the numbers, location, and mission of the laboratories needed to effectively counter biothreats; and national public health goals. Such information is needed to ensure that the United States will have facilities in the right place with the right specifications. Furthermore, since no single agency is in charge of the expansion, no one is determining the aggregate risks associated with this expansion. As a consequence, no federal agency can determine whether high-containment laboratory capacity may now meet or exceed the national need or is at a level that can be operated safely. If an agency were tasked, or a mechanism were established, with the purpose of overseeing the expansion of high-containment laboratories, it could develop a strategic plan to (1) ensure that the numbers and capabilities of potentially dangerous high-containment laboratories are no greater than necessary, (2) balance the risks and benefits of expanding such laboratories, and (3) determine the type of oversight needed. Four highly publicized incidents in high-containment laboratories, as well as evidence in scientific literature, demonstrate that (1) while laboratory accidents are rare, they do occur, primarily due to human error or systems (management and technical operations) failure, including the failure of safety equipment and procedures, (2) insiders can pose a risk, and (3) it is difficult to control inventories of biological agents with currently available technologies. Taken as a whole, these incidents demonstrate failures of systems and procedures meant to maintain biosafety and biosecurity in high-containment laboratories. For example, they revealed the failure to comply with regulatory requirements, safety measures that were not commensurate with the level of risk to public health posed by laboratory workers and pathogens in the laboratories, and the failure to fund ongoing facility maintenance and monitor the operational effectiveness of laboratory physical infrastructure. Oversight plays a critical role in improving biosafety and ensuring that high-containment laboratories comply with regulations. However, some aspects of the current oversight programs provided by the Departments of Health and Human Services and Agriculture are dependent upon entities monitoring themselves and reporting incidents to federal regulators. Since 2001, personnel reliability programs have been established to counter insider risks, but their cost, effectiveness, and impact has not been evaluated. Mon, 21 Sep 2009 00:00:00 -0400 http://www.gao.gov/new.items/d09909t.pdf As the current H1N1 outbreak underscores, an influenza pandemic remains a real threat to our nation. Over the past 3 years, GAO conducted a body of work, consisting of 12 reports and 4 testimonies, to help the nation better prepare for a possible pandemic. In February 2009, GAO synthesized the results of most of this work and, in June 2009, GAO issued an additional report on agency accountability for protecting the federal workforce in the event of a pandemic. GAO's work points out that while a number of actions have been taken to plan for a pandemic, including developing a national strategy and implementation plan, many gaps in pandemic planning and preparedness still remain. This statement covers six thematic areas: (1) leadership, authority, and coordination; (2) detecting threats and managing risks; (3) planning, training, and exercising; (4) capacity to respond and recover; (5) information sharing and communication; and (6) performance and accountability. (1) Leadership roles and responsibilities for an influenza pandemic need to be clarified, tested, and exercised, and existing coordination mechanisms, such as critical infrastructure coordinating councils, could be better utilized to address challenges in coordination between the federal, state, and local governments and the private sector in preparing for a pandemic. (2)Efforts are underway to improve the surveillance and detection of pandemic-related threats, but targeting assistance to countries at the greatest risk has been based on incomplete information, particularly from developing countries. (3) Pandemic planning and exercising has occurred at the federal, state, and local government levels, but important planning gaps remain at all levels of government. At the federal level, agency planning to maintain essential operations and services while protecting their employees in the event of a pandemic is uneven. (4) Further actions are needed to address the capacity to respond to and recover from an influenza pandemic, which will require additional capacity in patient treatment space, and the acquisition and distribution of medical and other critical supplies, such as antivirals and vaccines. (5) Federal agencies have provided considerable guidance and pandemic-related information to state and local governments, but could augment their efforts with additional information on school closures, state border closures, and other topics. (6) Performance monitoring and accountability for pandemic preparedness needs strengthening. For example, the May 2006 National Strategy for Pandemic Influenza Implementation Plan does not establish priorities among its 324 action items and does not provide information on the financial resources needed to implement them. Also, greater agency accountability is needed to protect federal workers in the event of a pandemic because there is no mechanism in place to monitor and report on agencies' progress in developing workforce pandemic plans. The current H1N1 pandemic should serve as a powerful reminder that the threat of a pandemic influenza, which seemed to fade from public awareness in recent years, never really disappeared. While federal agencies have taken action on 13 of GAO's 24 recommendations, 11 of the recommendations that GAO has made over the past 3 years have not been fully implemented. With the possibility that the H1N1 virus could become more virulent this fall or winter, the administration and federal agencies should use this time to turn their attention to filling in the planning and preparedness gaps GAO's work has pointed out. Wed, 29 Jul 2009 00:00:00 -0400 http://www.gao.gov/new.items/d09783t.pdf As evidenced by the spring 2009 outbreak of the H1N1 virus, an influenza pandemic remains a real threat to the nation and the world and has the potential to shut down work critical to the smooth functioning of society. This testimony addresses (1) the extent to which federal agencies have made pandemic plans to protect workers who cannot work remotely and are not first responders; (2) the pandemic plans selected agencies have for certain occupations performing essential functions other than first response; and (3) the opportunities to improve agencies' workforce pandemic plans. The issues discussed in the testimony are based on the GAO report, Influenza Pandemic: Increased Agency Accountability Could Help Protect Federal Employees Serving the Public in the Event of a Pandemic (GAO-09-404, June 12, 2009). In this report, GAO recommended that the Homeland Security Council (HSC) request that the Department of Homeland Security (DHS) monitor and report to the Executive Office of the President on the readiness of agencies to continue operations while protecting their employees in the event of a pandemic. To help carry out its oversight role, the Congress may want to consider requiring a similar report from DHS. The HSC noted that it will give serious consideration to the findings and recommendations in the report, and DHS said the report will contribute to its efforts to ensure government entities are well prepared for what may come next. GAO surveyed the 24 agencies employing nearly all federal workers to gain an overview of governmentwide pandemic influenza preparedness efforts and found that a wide range of pandemic planning activities are under way. However, as of early 2009, several agencies reported that they were still developing their pandemic plans and their measures to protect their workforce. For example, several agencies had yet to identify essential functions during a pandemic that cannot be performed remotely. In addition, although many of the agencies' pandemic plans rely on telework to carry out their functions, five agencies reported testing their information technology capability to little or no extent. To get a more in-depth picture of agency planning, GAO selected three case study agencies that represent essential occupations other than first response that cannot be performed remotely. The three case study occupations--correctional workers, production staff disbursing federal checks, and air traffic controllers--showed differences in the degree to which their individual facilities had operational pandemic plans. For example, the Bureau of Prisons' correctional workers had only recently been required to develop pandemic plans for their correctional facilities. Nevertheless, the Bureau of Prisons has considerable experience limiting the spread of infectious disease within its correctional facilities and had also made arrangements for antiviral medications for a portion of its workers and inmates. The Department of the Treasury's Financial Management Service, which has production staff involved in disbursing federal payments such as Social Security checks, had pandemic plans for its four regional centers and had stockpiled personal protective equipment such as respirators, gloves, and hand sanitizers at the centers. Air traffic control management facilities, where air traffic controllers work, had not yet developed facility pandemic plans or incorporated pandemic plans into their all-hazards contingency plans. The Federal Aviation Administration had recently completed a study to determine the feasibility of the use of respirators by air traffic controllers and concluded that their long-term use during a pandemic appears to be impractical. There is no mechanism in place to monitor and report on agencies' progress in developing workforce pandemic plans. Under the National Strategy for Pandemic Influenza Implementation Plan, DHS was required to monitor and report on the readiness of departments and agencies to continue operations while protecting their employees during an influenza pandemic. The HSC, however, informed DHS in late 2006 or early 2007 that no specific reports on this were required to be submitted. Rather, the HSC requested that agencies certify to the council that they were addressing in their plans the applicable elements of a pandemic checklist in 2006 and again in 2008. This process did not include any assessment or reporting on the status of agency plans. Given agencies' uneven progress in developing their pandemic plans, monitoring and reporting would enhance agencies' accountability for protecting their employees in the event of a pandemic. Tue, 16 Jun 2009 00:00:00 -0400 http://www.gao.gov/new.items/d09404.pdf Protecting federal workers essential to ensuring the continuity of the country's critical operations will involve new challenges in the event of a pandemic influenza outbreak. This requested report discusses (1) the extent to which agencies have made pandemic plans to protect workers who cannot work remotely and are not first responders, (2) the pandemic plans selected agencies have for certain occupations performing essential functions other than first response, and (3) the opportunities to improve agencies' workforce pandemic plans. GAO surveyed pandemic coordinators from 24 agencies and selected three case study occupations for review: federal correctional workers, staff disbursing Treasury checks, and air traffic controllers. The Homeland Security Council's (HSC) 2006 National Strategy for Pandemic Influenza Implementation Plan required federal agencies to develop operational pandemic plans, and responses from the pandemic coordinators of the 24 agencies GAO surveyed indicate that a wide range of pandemic planning activities are under way. However, the responses also showed that several agencies had yet to identify essential functions during a pandemic that cannot be performed remotely. In addition, although many of the agencies' pandemic plans rely on telework to carry out their functions, several agencies reported testing their information technology capability to little or no extent. GAO's three case study agencies also showed differences in the degree to which their individual facilities had operational pandemic plans. The Bureau of Prisons' correctional workers had only recently been required to develop pandemic plans for their correctional facilities. Nevertheless, the Bureau of Prisons has considerable experience limiting the spread of infectious disease within its correctional facilities and had also made arrangements for antiviral medications for a portion of its workers and inmates. The Department of the Treasury's Financial Management Service, which has production staff involved in disbursing federal payments such as Social Security checks, had pandemic plans for its four regional centers and had stockpiled personal protective equipment such as respirators, gloves, and hand sanitizers at the centers. Air traffic control management facilities, where air traffic controllers work, had not yet developed facility pandemic plans or incorporated pandemic plans into their all-hazards contingency plans. The Federal Aviation Administration had recently completed a study to determine the feasibility of the use of respirators by air traffic controllers and concluded that their long-term use during a pandemic appears to be impractical. There is no mechanism in place to monitor and report on agencies' workforce pandemic plans. Under the National Strategy for Pandemic Influenza Implementation Plan, the Department of Homeland Security (DHS) was required to monitor and report on the readiness of agencies to continue operations while protecting their employees during an influenza pandemic. The HSC, however, informed DHS in late 2006 or early 2007 that no specific reports on this were required to be submitted. Rather, the HSC requested that agencies certify to the council that they were addressing in their plans the applicable elements of a pandemic checklist in 2006 and again in 2008. This process did not include any assessment or reporting on the status of agency plans. Given agencies' uneven progress in developing their pandemic plans, monitoring and reporting would enhance agencies' accountability to protect their employees in the event of a pandemic. GAO has previously reported on the importance of internal control monitoring to assess the quality of performance over time. Without appropriately designed monitoring and reporting, the President and the Congress cannot fully assess the ability of the agencies to continue their operations while protecting their federal employees in the event of a pandemic. Fri, 12 Jun 2009 00:00:00 -0400 http://www.gao.gov/new.items/d09760t.pdf As the recent outbreak of the H1N1 (swine flu) virus underscores, an influenza pandemic remains a real threat to our nation and to the world. Over the past 3 years, GAO has conducted a body of work to help the nation better prepare for a possible pandemic. In a February 2009 report, GAO synthesized the results of this work, pointing out that while the previous administration had taken a number of actions to plan for a pandemic, including developing a national strategy and implementation plan, much more needs to be done, and many gaps in preparedness and planning still remain. This statement is based on the February 2009 report which synthesized the results of 11 reports and two testimonies covering six thematic areas: (1) leadership, authority, and coordination; (2) detecting threats and managing risks; (3) planning, training, and exercising, (4) capacity to respond and recover; (5) information sharing and communication; and (6) performance and accountability. (1) Leadership roles and responsibilities for an influenza pandemic need to be clarified, tested, and exercised, and existing coordination mechanisms, such as critical infrastructure coordinating councils, could be better utilized to address challenges in coordination between the federal, state, and local governments and the private sector in preparing for a pandemic. (2) Efforts are underway to improve the surveillance and detection of pandemic-related threats in humans and animals, but targeting assistance to countries at the greatest risk has been based on incomplete information, particularly from developing countries. (3) Pandemic planning and exercising has occurred at the federal, state, and local government levels, but important planning gaps remain at all levels of government. (4) Further actions are needed to address the capacity to respond to and recover from an influenza pandemic, which will require additional capacity in patient treatment space, and the acquisition and distribution of medical and other critical supplies, such as antivirals and vaccines. (5) Federal agencies have provided considerable guidance and pandemic-related information to state and local governments, but could augment their efforts with additional information on state border closures and other topics. (6) Performance monitoring and accountability for pandemic preparedness needs strengthening. For example, the May 2006 National Strategy for Pandemic Influenza Implementation Plan does not establish priorities among its 324 action items and does not provide information on the financial resources needed to implement them. The recent outbreak of the H1N1 influenza virus should serve as a powerful reminder that the threat of a pandemic influenza, which seemed to fade from public awareness in recent years, never really disappeared. While federal agencies have taken action on 13 of GAO's 23 recommendations, 10 of the recommendations that GAO has made over the past 3 years are still not fully implemented. With the possibility that the H1N1 virus could return in a more virulent form in a second wave in the fall or winter, the administration and federal agencies should turn their attention to filling in the planning and preparedness gaps GAO's work has pointed out. Wed, 03 Jun 2009 00:00:00 -0400 http://www.gao.gov/new.items/d09424t.pdf Veterinarians play an essential role in the defense against animal diseases, some of which can have serious repercussions for the health of animals, humans, and the economy. More than half of the federal veterinarians work in the Departments of Agriculture (USDA) and Health and Human Services (HHS). However, there is a growing national shortage of veterinarians. This testimony focuses primarily on two key points as addressed in GAO's recently released report, Veterinarian Workforce: Actions Are Needed to Ensure Sufficient Capacity for Protecting Public and Animal Health (GAO-09-178, February 4, 2009). First, the Office of Personnel Management (OPM) has not conducted a governmentwide effort to address current and future shortages of federal veterinarians; and, second, USDA and HHS have not assessed the sufficiency of their veterinarian workforces departmentwide. For the report, GAO, among other things, surveyed 24 federal component agencies about their veterinarian workforces. GAO also determined the extent to which the departments that employ about 96 percent of federal veterinarians, including USDA and HHS, have assessed the sufficiency of their veterinarian workforce. In addition, GAO interviewed officials of OPM to identify any initiatives it has conducted to address the sufficiency of the federal veterinarian workforce. Although OPM's mission is to ensure the federal government has an effective civilian workforce, OPM has not conducted a governmentwide effort to address current and future federal veterinarian shortages. This is problematic because the majority of the 24 component agencies that employ veterinarians reported concerns to GAO about the sufficiency of their veterinarian workforces. For example, USDA's Food Safety Inspection Service (FSIS) has not been fully staffed over the past decade, and HHS' National Institutes of Health faces challenges recruiting veterinarians that specialize in laboratory animal medicine and pathology. Moreover, this situation is likely to become more challenging as a large number of federal veterinarians become eligible to retire in the near future. For example, 30 percent of USDA's Animal and Plant Health Inspection Service (APHIS) veterinarians will be eligible to retire by the end of fiscal year 2011. USDA and HHS have not assessed the sufficiency of their veterinarian workforces departmentwide, despite the fact that their component agencies that employ mission-critical veterinarians are currently experiencing shortages or anticipating shortages in the future. As a result, USDA component agencies compete against one another for veterinarians instead of following a departmentwide strategy to balance the needs of these agencies. Specifically, APHIS is attracting veterinarians away from FSIS because the work at APHIS is more appealing, opportunities for advancement are greater, and the salaries are higher. Moreover, neither USDA nor HHS is fully aware of the status of its veterinarian workforce at its component agencies and, therefore, cannot strategically plan for future veterinarian needs. For example, senior HHS strategic workforce planning officials GAO spoke with were unaware of a 2007 report by one of its own Food and Drug Administration (FDA) advisory committees that found that FDA cannot fulfill its mission because of an insufficient scientific workforce, and that FDA's Center for Veterinary Medicine is in a state of crisis. To address these findings, GAO made numerous recommendations in its veterinarian workforce report. For example, GAO recommended that the Secretaries of Agriculture and Health and Human Services conduct departmentwide assessments of their veterinarian workforces to identify current and future workforce needs and departmentwide solutions to problems shared by its agencies. In addition, GAO recommended that the Director of the Office of Personnel Management determine, based on USDA's and HHS's departmentwide veterinarian workforce evaluations, whether a governmentwide effort is needed to address shortcomings in the sufficiency of the current and future veterinarian workforce. Thu, 26 Feb 2009 00:00:00 -0500 http://www.gao.gov/new.items/d09334.pdf GAO has conducted a body of work over the past several years to help the nation better prepare for, respond to, and recover from a possible influenza pandemic, which could result from a novel strain of influenza virus for which there is little resistance and which therefore is highly transmissible among humans. GAO's work has pointed out that while the previous administration had taken a number of actions to plan for a pandemic, including developing a national strategy and implementation plan, much more needs to be done. However, national priorities are shifting as a pandemic has yet to occur, and other national issues have become more immediate and pressing. Nevertheless, an influenza pandemic remains a real threat to our nation and the world. For this report, GAO synthesized the results of 11 reports and two testimonies issued over the past 3 years using six key thematic areas: (1) leadership, authority, and coordination; (2) detecting threats and managing risks; (3) planning, training, and exercising; (4) capacity to respond and recover; (5) information sharing and communication; and (6) performance and accountability. GAO also updated the status of recommendations in these reports. Leadership roles and responsibilities need to be clarified and tested, and coordination mechanisms could be better utilized. Shared leadership roles and responsibilities between the Departments of Health and Human Services (HHS) and Homeland Security (DHS) and other entities are evolving, and will require further testing and exercising before they are well understood. Although there are mechanisms in place to facilitate coordination between federal, state, and local governments and the private sector to prepare for an influenza pandemic, these could be more fully utilized. Efforts are underway to improve the surveillance and detection of pandemic-related threats, but targeting assistance to countries at the greatest risk has been based on incomplete information. Steps have been taken to improve international disease surveillance and detection efforts. However, information gaps limit the capacity for comprehensive comparisons of risk levels by country. Pandemic planning and exercising has occurred, but planning gaps remain. The United States and other countries, as well as states and localities, have developed influenza pandemic plans. Yet, additional planning needs still exist. For example, the national strategy and implementation plan omitted some key elements, and HHS found many major gaps in states' pandemic plans. Further actions are needed to address the capacity to respond to and recover from an influenza pandemic. An outbreak will require additional capacity in many areas, including the procurement of additional patient treatment space and the acquisition and distribution of medical and other critical supplies, such as antivirals and vaccines for an influenza pandemic. Federal agencies have provided considerable guidance and pandemicrelated information, but could augment their efforts. Federal agencies, such as HHS and DHS, have shared information in a number of ways, such as through Web sites and guidance, but state and local governments and private sector representatives would welcome additional information on vaccine distribution and other topics. Performance monitoring and accountability for pandemic preparedness needs strengthening. Although certain performance measures have been established in the National Pandemic Implementation Plan to prepare for an influenza pandemic, these measures are not always linked to results. Further, the plan does not contain information on the financial resources needed to implement it. GAO has made 23 recommendations in its reports--13 of these have been implemented and 10 remain outstanding. Continued leadership focus on pandemic preparedness remains vital, as the threat has not diminished. Thu, 26 Feb 2009 00:00:00 -0500 http://www.gao.gov/new.items/d09178.pdf Veterinarians are essential for controlling zoonotic diseases--which spread between animals and humans--such as avian influenza. Most federal veterinarians work in the Departments of Agriculture (USDA), Defense (DOD), and Health and Human Services (HHS). However, there is a growing national shortage of veterinarians. GAO determined the extent to which (1) the federal government has assessed the sufficiency of its veterinarian workforce for routine activities, (2) the federal government has identified the veterinarian workforce needed during a catastrophic event, and (3) federal and state agencies encountered veterinarian workforce challenges during four recent zoonotic outbreaks. GAO surveyed 24 federal entities about their veterinarian workforce; analyzed agency workforce, pandemic, and other plans; and interviewed federal and state officials that responded to four recent zoonotic outbreaks. The federal government lacks a comprehensive understanding of the sufficiency of its veterinarian workforce. More specifically, four of five component agencies GAO reviewed have assessed the sufficiency of their veterinarian workforce to perform routine activities and have identified current or future concerns. This includes USDA's Animal and Plant Health Inspection Services (APHIS), Food Safety and Inspection Service (FSIS), and Agricultural Research Service (ARS); and DOD's Army. Current and future shortages, as well as noncompetitive salaries, were among the concerns identified by these agencies. HHS's Food and Drug Administration (FDA) does not perform such assessments and did not identify any concerns. In addition, at the department level, USDA and HHS have not assessed their veterinarian workforces across their component agencies, but DOD has a process for doing so. Moreover, there is no governmentwide effort to search for shared solutions, even though 16 of the 24 federal entities that employ veterinarians raised concerns about the sufficiency of this workforce. Further exacerbating these concerns is the number of veterinarians eligible to retire in the near future. GAO's analysis revealed that 27 percent of the veterinarians at APHIS, FSIS, ARS, Army, and FDA will be eligible to retire within 3 years. Efforts to identify the veterinarian workforce needed for a catastrophic event are insufficient. Specifically, agencies' plans lack important elements necessary for continuing essential veterinarian functions during a pandemic, such as identifying which functions must be performed on-site and how they will be carried out if absenteeism reaches 40 percent--the rate predicted at the height of the pandemic and used for planning purposes. In addition, one federal effort to prepare for the intentional introduction of a foreign animal disease is based on the unrealistic assumption that all affected animals will be slaughtered, as the United States has done for smaller outbreaks, making the resulting veterinarian workforce estimates irrelevant. A second effort lacks crucial data, including data on how the disease would spread in wildlife. If wildlife became infected, as they have in the past, response would be greatly complicated and could require more veterinarians and different expertise. Officials from federal and state agencies involved in four recent zoonotic disease outbreaks commonly cited insufficient veterinarian capacity as a workforce challenge. However, 10 of the 17 agencies that GAO interviewed have not assessed their own veterinarian workforce's response to individual outbreaks and are thus missing opportunities to improve future responses. Moreover, none of the entities GAO reviewed has looked across outbreaks to identify common workforce challenges and possible solutions. Wed, 04 Feb 2009 00:00:00 -0500 http://www.gao.gov/new.items/d08671.pdf The emergence of the H5N1 avian influenza virus (also known as "bird flu") has raised concerns that it or another virus might mutate into a virulent strain that could lead to an influenza pandemic. Experts predict that a severe pandemic could overwhelm the nation's health care system, requiring the rationing of limited resources. GAO was asked to provide information on the progress of the Department of Health and Human Services's (HHS) plans for responding to a pandemic, including analyzing how HHS plans to (1) use pharmaceutical interventions to treat infected individuals and protect the critical workforce and (2) use nonpharmaceutical interventions to slow the spread of disease. To conduct this work, GAO reviewed government documents and scientific literature, and interviewed HHS officials, state and local public health officials, and subject-matter experts on pandemic response. HHS plans to make existing federal stockpiles of pharmaceutical interventions available for distribution once a pandemic begins. These interventions would include antivirals, which are drugs to prevent or reduce the severity of infection, and pre-pandemic vaccines, which are vaccines produced prior to a pandemic and developed from influenza strains that have the potential to cause a pandemic. HHS has established a national goal of stockpiling 75 million treatment courses of antivirals in the Strategic National Stockpile and in jurisdictional stockpiles. According to HHS, these public sector stockpiles are intended to be used primarily for the treatment of individuals sick with influenza. HHS intends to oversee the distribution and administration of pre-pandemic vaccine to individuals identified as members of the critical workforce. Members of the critical workforce--estimated to be about 20 million--include workers in sectors that are considered necessary to keep society functioning, such as health care and law enforcement personnel. HHS's strategy for using pre-pandemic vaccine is to keep society functioning until a pandemic vaccine--a vaccine specific to the pandemic-causing strain--becomes widely available. HHS anticipates that initial batches of a pandemic vaccine may not be available until 20 to 23 weeks after the start of the pandemic. As batches of the pandemic vaccine become available, HHS plans for state and local jurisdictions to provide it to members of targeted groups based on factors such as occupation and age, instead of making it available to the general public. HHS faces challenges implementing its strategy for using pharmaceutical interventions during a pandemic, including the lack of vaccine manufacturing capacity in the United States. HHS is currently making large investments to expand domestic vaccine manufacturing capacity. In 2008, HHS released guidance on prioritizing target groups for pandemic vaccine and draft guidance on antiviral use during a pandemic. HHS has not yet released draft guidance for public comment on prioritizing target groups for pre-pandemic vaccine. HHS will rely on state and local jurisdictions to utilize nonpharmaceutical interventions, such as isolation of sick individuals and voluntary home quarantine of those exposed to the pandemic strain. To assist state and local jurisdictions with implementing nonpharmaceutical interventions, HHS has developed guidance that describes the department's "community mitigation framework." The framework involves the early initiation of multiple nonpharmaceutical interventions, each of which is expected to be partially effective and to be maintained consistently throughout a pandemic. HHS faces difficulties, including helping jurisdictions develop ways to ensure community compliance. HHS is investing in several initiatives to increase the nation's knowledge about the general use and effectiveness of nonpharmaceutical interventions. The findings from this research will be used to update existing guidance. Tue, 30 Sep 2008 00:00:00 -0400 http://www.gao.gov/new.items/d08539.pdf The Implementation Plan for the National Strategy for Pandemic Influenza states that in an influenza pandemic, the primary response will come from states and localities. To assist them with pandemic planning and exercising, Congress has provided $600 million to states and certain localities. The Department of Homeland Security (DHS) established five federal influenza pandemic regions to work with states to coordinate planning and response efforts. GAO was asked to (1) describe how selected states and localities are planning for an influenza pandemic and who they involved, (2) describe the extent to which selected states and localities conducted exercises to test their influenza pandemic planning and incorporated lessons learned as a result, and (3) identify how the federal government can facilitate or help improve state and local efforts to plan and exercise for an influenza pandemic. GAO conducted site visits to five states and 10 localities. All of the five states and 10 localities reviewed by GAO had developed influenza pandemic plans. In fact, according to officials at the Centers for Disease Control and Prevention (CDC), which administers the federal pandemic funds, all 50 states have developed an influenza pandemic plan, in accordance with federal pandemic funding requirements. At the time of GAO's site visits, officials from the selected states and localities reviewed said that they involved the federal government, other state and local agencies, tribal nations, and nonprofit and private sector organizations in their influenza pandemic planning. Since GAO's site visits, the Department of Health and Human Services (HHS) has provided feedback to the states, territories, and the District of Columbia (hereafter referred to as states) on whether their plans addressed 22 priority areas, such as policy process for school closure and communication. On average the department found that states' plans had "many major gaps" in 16 of the 22 priority areas. In March 2008, HHS, DHS, and other federal agencies issued guidance to states to help them update their pandemic plans, which are due by July 2008, in preparation for another HHS-led review. According to CDC officials, all states and localities that received the federal pandemic funds have met the requirement to conduct an exercise to test their plans. Officials from all of the states and localities reviewed by GAO reported that they had incorporated lessons learned from influenza pandemic exercises into their influenza pandemic planning, such as buying additional medical equipment, providing training, and modifying influenza pandemic plans. For example, as a result of an exercise, officials at the Dallas County Department of Health and Human Services (Texas) reported that they developed an appendix to their influenza pandemic plan on school closures during a pandemic. The federal government has provided influenza pandemic guidance on a variety of topics including an influenza pandemic planning checklist for states and localities and draft guidance on allocating an influenza pandemic vaccine. However, officials of the states and localities reviewed by GAO told GAO that they would welcome additional guidance from the federal government in a number of areas to help them to better plan and exercise for an influenza pandemic, in areas such as community containment (community-level interventions designed to reduce the transmission of a pandemic virus). Three of these areas were also identified as having "many major gaps" in states' plans nationally in the HHS-led review. In January 2008, HHS and DHS, in coordination with other federal agencies, hosted a series of meetings of states in the five federal influenza pandemic regions to discuss the draft guidance on updating their pandemic plans. Although a senior DHS official reported that there are no plans to conduct further workshops, additional regional meetings could provide a forum for state and federal officials to address gaps in states' planning identified by the HHS-led review and to maintain the momentum of states' pandemic preparedness through this next governmental transition. Thu, 19 Jun 2008 00:00:00 -0400 http://www.gao.gov/new.items/d08768.pdf Hurricane Katrina illustrated that effective preparation and response to a catastrophe requires a joint effort between federal, state, and local government. The Department of Homeland Security (DHS), through the Federal Emergency Management Agency (FEMA), is responsible for heading the joint effort. In January 2008, DHS released the National Response Framework (NRF), a revision of the 2004 National Response Plan (2004 Plan), the national preparation plan for all hazards. In response to the explanatory statement to the Consolidated Appropriations Act of 2008 and as discussed with congressional committees, this report evaluates the extent to which (1) DHS collaborated with non-federal stakeholders in revising and updating the 2004 Plan into the 2008 NRF and (2) FEMA has developed policies and procedures for managing future NRF revisions. To accomplish these objectives, GAO reviewed DHS and FEMA documents related to the revision process, analyzed the relevant statutes, and interviewed federal and non-federal officials who held key positions in the revision process. While DHS included non-federal stakeholders--state, local, and tribal governments, nongovernmental organizations, and the private sector--in the initial and final stages of revising the 2004 Plan into the NRF, it did not collaborate with these stakeholders as fully as it originally planned or as required by the October 2006 Post-Katrina Emergency Management Reform Act (Post-Katrina Act). As the revision process began in 2006, DHS involved both federal and non-federal stakeholders by soliciting and incorporating their input in determining the key revision issues and developing the first draft in April 2007. However, after this first draft was completed, DHS deviated from its revision work plan by conducting a closed, internal federal review of the draft rather than releasing it for stakeholder comment because the draft required further modifications DHS considered necessary. DHS limited communication with non-federal stakeholders until it released a draft for public comment 5 months later on September 10, 2007. The following day, non-federal stakeholders testified at a congressional hearing that DHS had shut them out during that 5-month period. In addition, the Post-Katrina Act required that DHS establish a National Advisory Council (NAC) for the FEMA Administrator by December 2006 to, among other things, incorporate nonfederal stakeholders' input in the revision process. However, FEMA stated the necessary time to select quality NAC members required additional time, and FEMA did not announce the NAC's membership until June 2007. The NAC did not provide comments on a revision draft until one month before DHS publicly released the final NRF in January 2008. FEMA anticipates that the NRF will be revised in the future; however, FEMA does not have policies or procedures in place to guide this process or ensure a collaborative partnership with stakeholders. FEMA has emphasized the importance of partnering with relevant stakeholders to effectively prepare for and respond to major and catastrophic disasters, and the Congress, through the Post-Katrina Act, requires such partnership. In addition, the Standards for Internal Controls in the Federal Government calls for policies and procedures that establish regular communication with stakeholders and monitor performance over time as essential for achieving desired program goals. Furthermore, previous GAO work on the Department of Defense's civil support plans and the administration's national pandemic influenza implementation plan has shown the need for participation of state and local jurisdictions in emergency planning. Especially in view of a new administration, the experience of the previous revision process illustrates the importance of collaborating with stakeholders in revising a plan that relies on them for its successful implementation. While the NRF is published by DHS, it belongs to the nation's emergency response community. Developing such policies and procedures is essential for ensuring that FEMA attains the Post- Katrina Act's goal of partnering with non-federal stakeholders in building the nation's emergency management system, including the periodic review and revision of the NRF. Wed, 11 Jun 2008 00:00:00 -0400 http://www.gao.gov/new.items/d08314.pdf Supplemental appropriations laws (supplementals) are a tool for policymakers to address needs that arise after the fiscal year has begun. Supplementals provide important and necessary flexibility but some have questioned whether supplementals are used just to meet the needs of unforeseen events or whether they also include funding for activities that could be covered in regular appropriations acts. GAO was asked to evaluate (1) trends in supplemental appropriations enacted from fiscal years 1997-2006 and (2) steps that could be taken to increase transparency and establish additional controls over emergency supplemental appropriations. Also, GAO consulted with budget experts to discuss options for reform. The use of supplementals has increased over the last several years, largely as a result of an increase in Department of Defense (DOD) funding and the use of supplementals to provide that funding for activities such as the Global War on Terrorism (GWOT). Over the 10-year period from fiscal year 1997 through fiscal year 2006, supplemental appropriations provided about $612 billion ($557 billion net of rescissions) in new gross budget authority, a five-fold increase over the previous 10-year period. Ninety-five percent of the total supplemental funds were appropriated to 11 departments, with DOD receiving nearly 60 percent of the total. Further, an analysis of the type of emergency prompting the need for the supplemental shows that defense-related emergencies received over 50 percent of the emergency-designated funds. In comparison, 28 percent was to respond to natural or economic disasters and 16 percent went to antiterror, security, and post-9/11 activities. International humanitarian assistance, pandemic influenza, and other activities comprised 3 percent of the total emergency-designated supplemental funds provided over the 10-year period. The majority of the supplemental funds appropriated over this 10-year period were designated as emergency. Emergency-designated funds do not have to compete for scarce resources that are constrained by budget controls. Although Congress has specified criteria for the emergency designation in Budget Resolutions, these criteria are not self-executing and there are limited screening and enforcement processes. The increased use of supplementals raises questions about the current incentives and controls surrounding their use. GAO reviewed emergency-designated supplementals and found provisions that were not clearly consistent with emergency designation criteria or did not contain sufficient information for us to make a determination. Also, GAO identified provisions that raise questions about whether supplemental appropriations bills can become vehicles for funding some activities that could be covered in the regular budget and appropriations process. For example, we found $710 million in emergency-designated provisions that appeared to be unrelated to the event/issue(s) that may have prompted the supplemental. In addition, we found that 35 accounts received supplemental appropriations in at least 6 of the 10 years studied, totaling over $375 billion. Twenty-one of these accounts were in DOD and the gross budget authority granted to these 21 accounts ($258 billion) comprised over 40 percent of the total gross budget authority in the supplemental appropriations enacted over the studied period. Finally, over one-third of the supplemental appropriations enacted were available until expended ("no-year" funds). Such no-year funds provide agencies with important flexibility but do not prompt the annual or periodic Congressional oversight typical of funds that are available for a fixed amount of time. If the use of supplemental appropriations is to be limited to addressing unforeseen needs that arise suddenly after the start of a fiscal year, additional controls and increased transparency are needed. Budget experts GAO consulted generally agreed reform was needed but differed on how best to achieve this. Thu, 31 Jan 2008 00:00:00 -0500 http://www.gao.gov/new.items/d0892.pdf Pandemic influenza poses a threat to public health at a time when the United Nations' World Health Organization (WHO) has said that infectious diseases are spreading faster than at any time in history. The last major influenza pandemic occurred from 1918 to 1919. Estimates of deaths worldwide if a similar pandemic were to occur have ranged between 30 million and 384 million people. Individual countries and international organizations have developed and begun to implement a strategy for forestalling (that is, containing, delaying, or minimizing the impact of) the onset of a pandemic. Antivirals and vaccines may help forestall a pandemic. GAO was asked to examine (1) constraints upon the use of antivirals and vaccines to forestall a pandemic and (2) efforts under way to overcome these constraints. GAO reviewed documents and consulted with officials of the Departments of State and Health and Human Services (HHS), international organizations, and pharmaceutical manufacturers. WHO commented that the report was comprehensive and useful. HHS stressed that vaccines and antivirals must be viewed in a larger context. State and HHS commented that the term "forestall" is ambiguous and misleading. However, GAO has used the word in a way that is consistent with WHO's use of the term. The use of antivirals and vaccines, two elements of the international strategy to forestall a pandemic, could be constrained by their uncertain effectiveness and limited availability. To use antivirals effectively, health authorities must be able to detect a pandemic influenza strain quickly through surveillance and diagnostic efforts and use this information to administer antivirals. The effectiveness of antivirals could be limited if they are used more than 48 hours after the onset of symptoms or by the emergence of strains resistant to antivirals. Unlike antivirals, vaccines are formulated to target a specific influenza strain in advance of infection. The effectiveness of vaccines in forestalling a pandemic could be limited because such a targeted pandemic vaccine cannot be developed until that strain has been identified. Due to the time required to identify the virus and develop and manufacture a pandemic vaccine--20 to 23 weeks according to HHS--such vaccines are likely to play little or no role in efforts to forestall a pandemic in its initial phases. The availability of antivirals and vaccines in a pandemic could be inadequate due to limited production, distribution, and administration capacity. WHO has stated that it is unlikely that sufficient quantities of antivirals will be available in any country at the onset of a pandemic. The distribution and administration capacity for antivirals and vaccines is limited in some countries by poor or nonexistent delivery plans and networks, a lack of facilities for administering the drugs, and small numbers of personnel trained to administer them. The United States, its international partners, and the pharmaceutical industry are investing substantial resources to address constraints on the availability and effectiveness of antivirals and vaccines. Efforts are under way to improve influenza surveillance, including diagnostic capabilities, so that outbreaks can be quickly detected. Increased demand and government support has led manufacturers to increase research into more effective antivirals and vaccines. Manufacturers are developing new antivirals to combat influenza. New methods for developing vaccines are being studied in order to reduce the amount of vaccine that is needed and to increase the number of strains against which it is effective. Pre-pandemic vaccines, which are formulated to target influenza strains that have the potential to cause a pandemic, are being developed. However, these vaccines may or may not be effective against the pandemic strain that ultimately emerges. To overcome limitations on the availability of antivirals and vaccines, manufacturers are working to increase production at existing facilities and build new facilities. To address constraints on the distribution and administration of antivirals, stockpiles are being established to allow faster delivery of antivirals to countries experiencing outbreaks. WHO is also working to establish stockpiles of pre-pandemic vaccines. Additionally, other efforts also face limitations. For example, increasing production capacity of vaccines and antivirals will take several years as new facilities are built and necessary materials acquired. Fri, 21 Dec 2007 00:00:00 -0500 http://www.gao.gov/new.items/d0827.pdf Annual vaccination is the main method for preventing seasonal influenza, which typically occurs in the United States from late fall to early spring. Manufacturers produce vaccine through a lengthy and complex process. Manufacturers and medical supply distributors then ship vaccine to providers such as physicians. Each year, the Department of Health and Human Services's (HHS) Centers for Disease Control and Prevention (CDC) recommends who should be targeted for vaccination, including those at higher risk for influenza-related complications or medical care--for example, adults aged 50 years and older, young children, and some individuals with chronic medical conditions. CDC bases its recommendations on those made by the agency's Advisory Committee on Immunization Practices (ACIP). GAO examined: (1) factors that affect the quantity of vaccine produced and when it reaches providers, (2) issues related to making vaccine available to high-risk and other target groups, and (3) public health messages produced and disseminated by CDC and others to promote vaccination. GAO reviewed relevant documents and interviewed officials from CDC, other public health entities, manufacturers, and medical supply distributors, and examined data on vaccine doses produced and shipped. Several factors affect the quantity of vaccine produced for a given influenza season and when it reaches providers who administer the vaccine. One factor is the difficulty of manufacturing a new vaccine each year, which includes adherence to a relatively inflexible and sequential process, challenges of growing new virus strains, and maintaining safety and quality control practices to produce a sterile vaccine. Other factors include limitations in the production capacity of manufacturers and demand for vaccine throughout the influenza season. In addition, the distribution route the vaccine takes from the manufacturer to the provider can also affect how much time elapses before the vaccine reaches individual providers. Issues related to making vaccine available to high-risk and other target groups recommended by CDC and ACIP include the locations in which these individuals receive vaccinations, how vaccine is distributed to providers, and the timing of vaccine distribution to different types of providers. According to data from CDC, individuals in high-risk and other target groups have received influenza vaccinations at various locations where different types of providers administer the vaccine, including physicians' offices, workplaces, clinics, or other settings. Certain types of providers, such as physicians, reported that they received their vaccine orders after other types of providers, such as mass immunizers that provide vaccinations at retail stores. Available data for the 2006-07 influenza season indicated, however, that most types of providers received vaccine in similar time frames. CDC officials acknowledged that individual providers' experiences at the local level could vary. In an effort to help state and local health officials manage the availability of vaccine for high-risk or other target groups, CDC and state health officials have undertaken several efforts, including the creation of monitoring tools and the implementation of a state-specific vaccine distribution program. CDC and others have produced and disseminated public health messages--such as press releases and public service announcements--designed to promote seasonal influenza vaccination. These include messages designed to maintain public demand for vaccination later in the influenza season and to encourage preferential vaccination of certain groups during times of vaccine shortage or delay. CDC has taken steps to assess its influenza-related public health messages before disseminating them to the public and has conducted limited data collection afterwards. Although no comprehensive evaluations have been conducted to assess the impact of influenza-related messages after dissemination, CDC and other officials GAO interviewed identified key elements, such as clear and consistent messages, that they believe are important to producing effective public health messages. However, there are impediments to effectively implementing these elements, such as the need to modify messages during the season as circumstances change. We provided a draft of this report to HHS for comment. The department provided technical comments, which we incorporated as appropriate. Wed, 31 Oct 2007 00:00:00 -0400 http://www.gao.gov/new.items/d0836.pdf An outbreak of pandemic flu would require close cooperation between the public and private sectors to ensure the protection of our nation's critical infrastructure, such as drinking water and electricity. Because over 85 percent of the nation's critical infrastructure is owned and operated by the private sector, it is vital that both sectors effectively coordinate to successfully protect these assets. The Department of Homeland Security (DHS) is responsible for coordinating a national protection strategy and government and private sector councils have been created as a collaborating tool. GAO was asked to assess how the federal and private sectors are working together at a national level to protect the nation's critical infrastructure in the event of a pandemic, the challenges they face, and opportunities for addressing these challenges. GAO reviewed 5 of the 17 critical infrastructure sectors. These 5 sectors are energy (electricity), food and agriculture, telecommunications, transportation (highway and motor carrier), and water. Federal agencies and the private sector have worked together to (1) develop general pandemic preparedness guidance, such as checklists for continuity of business operations during a pandemic; (2) identify the number of critical workers essential to the critical infrastructure sectors' operations during a pandemic; and (3) conduct pandemic preparedness presentations, workshops, forums, and some exercises. In some instances, the federal and private sectors are working together through sector-specific and cross-sector councils as the primary means of coordinating government and private sector efforts at the national level to protect critical infrastructure. Federal and private sector representatives from the councils in the five sectors reviewed told GAO that they have taken some initial pandemic preparedness actions within their respective sectors. Additionally, each of the sectors is collaborating with DHS and other sector-specific agencies, such as the Environmental Protection Agency, to develop sector-specific pandemic guidance. The federal government and the private sector face several challenges that may impede their efforts to protect the nation's critical infrastructure in the event of a pandemic. Maintaining a focus on pandemic planning efforts is difficult in the face of more immediate priorities, such as responding to outbreaks of foodborne illnesses. Private sector officials are concerned about the lack of clarity on the federal versus state roles in areas such as state border closures and pandemic vaccine distribution. They are also concerned about receiving consistent messages from various government entities providing pandemic-related information. Another challenge is identifying and developing strategies for addressing crucial cross-sector interdependencies that will be important for the continued operation of the nation's economy and society during a pandemic, such as the transportation sector to deliver critical supplies. Obtaining needed investments for training and infrastructure and potential legal and regulatory issues also present challenges. Increased use of the critical infrastructure coordinating councils could help address issues relating to a pandemic. These councils bring together multiple sectors and levels of governments, linking activities between these entities. Despite their potential, the councils' efforts thus far have focused mostly on the development of sector-specific plans to address all hazards. With regard to a pandemic specifically, DHS has used the councils primarily to share information across sectors and government levels rather than to address many of the identified challenges. Because an outbreak could begin at any time, there may be insufficient time and resources to adequately plan and prepare their members for changes in how their sectors may operate and continue to provide essential services during a pandemic. DHS officials acknowledge that they could encourage greater federal and private sector use of the councils and that the councils could be used to initiate and facilitate pandemic preparedness initiatives. DHS, because it is responsible for coordinating national critical infrastructure protection efforts, is well positioned to lead efforts to use these councils to help address these challenges. Wed, 31 Oct 2007 00:00:00 -0400 http://www.gao.gov/new.items/d08138t.pdf The rapid spread of severe acute respiratory syndrome (SARS) in 2003 showed that disease outbreaks pose a threat beyond the borders of the country where they originate. The United States has initiated a broad effort to ensure that countries can detect outbreaks that may constitute a public health emergency of international concern. Three U.S. agencies--the Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), and the Department of Defense (DOD)--support programs aimed at building this broader capacity to detect a variety of infectious diseases. This testimony describes (1) the obligations, goals, and activities of these programs and (2) the U.S. agencies' monitoring of the programs' progress. To address these objectives, GAO reviewed budgets and other funding documents, examined strategic plans and program monitoring and progress reports, and interviewed U.S. agency officials. GAO did not review capacity-building efforts in programs that focus on specific diseases, namely polio, tuberculosis, malaria, avian influenza, or HIV/AIDS. This testimony is based on a report (GAO-07-1186), which is being released with this testimoy. GAO did not make recommendations. The agencies whose programs we describe reviewed our report and generally concurred with our findings. We incorporated their technical comments as appropriate. The U.S. government operates or supports four key programs aimed at building overseas surveillance capacity for infectious diseases. In fiscal years 2004-2006, U.S. agencies obligated approximately $84 million for these programs, which operate in developing countries around the world. Global Disease Detection is CDC's main effort to help build capacity for infectious disease surveillance in developing countries. The Field Epidemiology Training Programs, which CDC and USAID support, are another tool used to help build infectious disease surveillance capacity worldwide. Additionally, USAID supports CDC and the World Health Organization's Regional Office for Africa in designing and implementing Integrated Disease Surveillance and Response in 46 countries in Africa, with additional technical assistance to 8 African countries. DOD's Global Emerging Infections Surveillance and Response System also contributes to capacity building through projects undertaken at DOD overseas research laboratories. USAID supports additional capacity-building projects in various developing countries. For each of the four key surveillance capacity-building programs, the U.S. agencies monitor activities such as the number of epidemiologists trained, the number of outbreak investigations conducted, and types of laboratory training completed. In addition, CDC and USAID recently began systematic efforts to evaluate the impact of their programs; however, because no evaluations had been completed as of July 2007, it is too early to assess whether these evaluation efforts will demonstrate progress in building surveillance capacity. Thu, 04 Oct 2007 00:00:00 -0400 http://www.gao.gov/new.items/d08108t.pdf In response to the global spread of emerging infectious diseases and the threat of bioterrorism, high-containment biosafety laboratories (BSL)--specifically biosafety level (BSL)-3 and BSL-4--have been proliferating in the United States. These labs--classified by the type of agents used and the risk posed to personnel, the environment, and the community--often contain the most dangerous infectious disease agents, such as Ebola, smallpox, and avian influenza. This testimony addresses (1) the extent to which there has been a proliferation of BSL-3 and BSL-4 labs, (2) federal agencies' responsibility for tracking this proliferation and determining the associated risks, and (3) the lessons that can be learned from recent incidents at three high-containment biosafety labs. To address these objectives, GAO asked 12 federal agencies involved with high-containment labs about their missions and whether they tracked the number of labs overall. GAO also reviewed documents from these agencies, such as pertinent legislation, regulation, and guidance. Finally, GAO interviewed academic experts in microbiological research. A major proliferation of high-containment BSL-3 and BSL-4 labs is taking place in the United States, according to the literature, federal agency officials, and experts. The expansion is taking place across many sectors--federal, academic, state, and private--and all over the United States. Concerning BSL-4 labs, which handle the most dangerous agents, the number of these labs has increased from 5--before the terrorist attacks of 2001--to 15, including at least 1 in planning stage. Information on expansion is available about high-containment labs that are registered with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture's (USDA) Select Agent Program, and that are federally funded. However, much less is known about the expansion of labs outside the Select Agent Program, as well as the nonfederally funded labs, including location, activities, and ownership. No single federal agency, according to 12 agencies' responses to our survey, has the mission to track the overall number of BSL-3 and BSL-4 labs in the United States. Though several agencies have a need to know, no one agency knows the number and location of these labs in the United States. Consequently, no agency is responsible for determining the risks associated with the proliferation of these labs. We identified six lessons from three recent incidents: failure to report to CDC exposures to select agents by Texas A&M University (TAMU); power outage at the CDC's new BSL-4 lab in Atlanta, Georgia; and release of foot-and-mouth disease virus at Pirbright in the United Kingdom. These lessons highlight the importance of (1) identifying and overcoming barriers to reporting in order to enhance biosafety through shared learning from mistakes and to assure the public that accidents are examined and contained; (2) training lab staff in general biosafety, as well as in specific agents being used in the labs to ensure maximum protection; (3) developing mechanisms for informing medical providers about all the agents that lab staff work with to ensure quick diagnosis and effective treatment; (4) addressing confusion over the definition of exposure to aid in the consistency of reporting; (5) ensuring that BSL-4 labs' safety and security measures are commensurate with the level of risk these labs present; and (6) maintenance of high-containment labs to ensure integrity of physical infrastructure over time. Thu, 04 Oct 2007 00:00:00 -0400 http://www.gao.gov/new.items/d071186.pdf The rapid spread of severe acute respiratory syndrome (SARS) in 2003 shows that disease outbreaks pose a threat beyond the borders of the country where they originate. Over the past decade, the United States has initiated a broad effort to ensure that countries can detect any disease outbreaks that may constitute a public health emergency of international concern. Three U.S. agencies--the Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), and the Department of Defense (DOD)--support programs aimed at building this broader capacity to detect a variety of infectious diseases. This report describes (1) the obligations, goals, and activities of these programs and (2) the U.S. agencies' monitoring of the programs' progress. To address these objectives, GAO reviewed budgets and other funding documents, examined strategic plans and program monitoring and progress reports, and interviewed U.S. agency officials. GAO did not review capacity-building efforts in programs that focus on specific diseases, namely polio, tuberculosis, malaria, avian influenza, or HIV/AIDS. GAO is not making any recommendations. The U.S. agencies whose programs we describe reviewed a draft of this report and generally concurred with our findings. They also provided technical comments, which we incorporated as appropriate. The U.S. government operates or supports four key programs aimed at building overseas surveillance capacity for infectious diseases. In fiscal years 2004-2006, U.S. agencies obligated approximately $84 million for these programs, which operate in developing countries around the world. Global Disease Detection is CDC's main effort to build capacity for infectious disease surveillance in developing countries. The Field Epidemiology Training Programs, which CDC and USAID support, are another tool used to build infectious disease surveillance capacity worldwide. Additionally, USAID supports CDC and the World Health Organization's Regional Office for Africa in designing and implementing Integrated Disease Surveillance and Response in 46 countries in Africa, with additional technical assistance to 8 African countries. DOD's Global Emerging Infections Surveillance and Response System also contributes to capacity building through projects undertaken at DOD overseas research laboratories. USAID supports additional capacity-building projects in various developing countries. The responsible agencies coordinate with each other to limit duplication of their overseas efforts. For each of the four key surveillance capacity-building programs, the U.S. agencies monitor activities such as the number of epidemiologists trained, the number of outbreak investigations conducted, and types of laboratory training completed. In addition, CDC and USAID recently began systematic efforts to evaluate the impact of their programs; however, because no evaluations had been completed as of July 2007, it is too early to assess whether these evaluation efforts will demonstrate progress in building surveillance capacity. Fri, 28 Sep 2007 00:00:00 -0400 http://www.gao.gov/new.items/d071259t.pdf The federal executive boards (FEB) bring together federal agency and community leaders in major metropolitan areas outside Washington, D.C., to discuss issues of common interest, including pandemic influenza. This testimony addresses the FEBs' emergency support roles and responsibilities, their potential role in pandemic influenza preparedness, and some of the key challenges they face in providing emergency support services. The issues discussed in the testimony are based on the GAO report, The Federal Workforce: Additional Steps Needed to Take Advantage of Federal Executive Boards' Ability to Contribute to Emergency Operations (GAO-07- 515, May 2007). GAO selected 14 of the 28 FEBs for review because they coordinate the greatest number of federal employees or had recent emergency management experience. In this report, GAO recommended that the Director of the Office of Personnel Management (OPM) work with the Federal Emergency Management Agency (FEMA) to formally define the FEBs' role in emergency planning and response. In completing the FEB strategic plan, OPM should also establish accountability for the boards' emergency support activities and develop a proposal to address the uncertainty of funding sources for the boards. While not commenting specifically on the recommendations, OPM said it is building a business case through which to address the resources FEBs need to continue operations. Located in 28 cities with a large federal presence, the FEBs are interagency coordinating groups designed to strengthen federal management practices and improve intergovernmental relations. The FEBs bring together the federal agency leaders in their service areas and have a long history of establishing and maintaining communications links, coordinating intergovernmental activities, identifying common ground, and building cooperative relationships. The boards also partner with community organizations and participate as a unified federal force in local civic affairs. OPM, which provides direction to the FEBs, and the boards have designated emergency preparedness, security, and safety as an FEB core function and are continuing to work on a strategic plan that will include a common set of performance standards for their emergency support activities. Although not all FEB representatives agreed that the boards should play an expanded role in emergency service support, many of the FEB representatives cited a positive and beneficial working relationship with FEMA. As one of their emergency support activities, the FEBs and FEMA, often working with the General Services Administration, host emergency planning exercises and training for federal agencies in the field. The FEBs' emergency support role with its regional focus may make the boards a valuable asset in pandemic preparedness and response. The distributed nature of a pandemic and the burden of disease across the nation dictate that the response will be largely addressed by each community it affects. As a natural outgrowth of their general civic activities and through activities such as hosting emergency preparedness training, some of the boards have established relationships with, for example, federal, state, and local governments; emergency management officials; first responders; and health officials in their communities. Some of the FEBs are already building capacity for pandemic influenza response within their member agencies and community organizations by hosting pandemic influenza training and exercises. The communications function of the FEBs is also a key part of their emergency support activities and could be an important asset for pandemic preparedness and response. The FEBs, however, face key challenges in providing emergency support, and these interrelated issues limit the capacity of the FEBs to provide a consistent and sustained contribution to emergency preparedness and response. First, their role is not defined in national emergency plans, which may contribute to federal agency officials being unfamiliar with their capabilities. In addition, with no congressional appropriations, the FEBs depend on host agencies and other member agencies for their resources. This has resulted in inconsistent funding for the FEBs nationwide and creates uncertainty for the boards in planning and committing to provide emergency support services. Fri, 28 Sep 2007 00:00:00 -0400 http://www.gao.gov/new.items/d071257t.pdf An influenza pandemic is a real and significant potential threat facing the United States and the world. Pandemics are unlike other emergencies because they are not a singular event nor discretely bounded in space and time. This testimony addresses (1) federal leadership roles and responsibilities for preparing for and responding to a pandemic, (2) our assessment of the Strategy and Plan, and (3) opportunities to increase clarity of federal leadership roles and responsibilities and improve pandemic planning. GAO used its characteristics of an effective national strategy to assess the Strategy and Plan. The issues discussed in the testimony are based primarily on the GAO report, Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer Federal Leadership Roles and an Effective National Strategy (GAO-07-781). In this report, GAO recommended that (1) The Secretaries of Homeland Security and Health and Human Services develop rigorous testing, training, and exercises for pandemic influenza to ensure that federal leadership roles and responsibilities are clearly defined, understood and work effectively and (2) HSC set a time frame to update the Plan, involve key stakeholders, and more fully address the characteristics of an effective national strategy. The Departments of Homeland Security and Health and Human Services concurred. The HSC did not comment. The administration has taken an active approach to this potential disaster by, among other things, issuing a National Strategy for Pandemic Influenza (Strategy) in November 2005, and a National Strategy for Pandemic Influenza Implementation Plan (Plan) in May 2006. However, much more needs to be done to ensure that the Strategy and Plan are viable and can be effectively implemented in the event of an influenza pandemic. Key federal leadership roles and responsibilities for preparing for and responding to a pandemic continue to evolve and will require further clarification and testing before the relationships of the many leadership positions are well understood. Most of these leadership roles involve shared responsibilities and it is unclear how they will work in practice. Because initial actions may help limit the spread of an influenza virus, the effective exercise of shared leadership roles and responsibilities could have substantial consequences. However, only one national, multi-sector pandemic-related exercise has been held, and that was prior to issuance of the Plan. The Strategy and Plan do not fully address the characteristics of an effective national strategy and contain gaps that could hinder the ability of key stakeholders to effectively execute their responsibilities. Specifically, some of the gaps include (1) The Strategy and Plan do not address resources, investments, and risk management and consequently do not provide a picture of priorities or how adjustments might be made in view of limited resources. (2) State and local jurisdictions were not directly involved in developing the Plan, even though they would be on the front lines in a pandemic. (3) Relationships and priorities among action items are not always clear. (4) Performance measures are focused on activities that are not always linked to results. (5) The linkage of the Strategy and Plan with other key plans is unclear. (6) The Plan does not contain a process for monitoring and reporting on progress. (7) The Plan does not describe an overall framework for accountability and oversight and does not clarify how responsible officials would share leadership responsibilities. (8) Procedures and time frames for updating and revising the Plan were not established. These gaps can affect the usefulness of these planning documents for those with key roles to play. Also, the lack of mechanisms for future updates or progress assessments limit opportunities for congressional decision makers and the public to assess the extent of progress being made or to consider what areas or actions may be need additional attention. Although the Homeland Security Council (HSC) publicly reported on the status of action items in December 2006 and July 2007, it is unclear when the next report will be issued or how much information will be released. Wed, 26 Sep 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07781.pdf An influenza pandemic is a real and significant potential threat facing the United States and the world. Pandemics occur when a novel virus emerges that can easily be transmitted among humans who have little immunity. In 2005, the Homeland Security Council (HSC) issued a National Strategy for Pandemic Influenza and, in 2006, an Implementation Plan. Congress and others are concerned about the federal government's preparedness to lead a response to an influenza pandemic. This report assesses how clearly federal leadership roles and responsibilities are defined and the extent to which the Strategy and Plan address six characteristics of an effective national strategy. To do this, GAO analyzed key emergency and pandemic-specific plans, interviewed agency officials, and compared the Strategy and Plan with the six characteristics GAO identified. The executive branch has taken an active approach to help address this potential threat, including establishing an online information clearinghouse, developing planning guidance and checklists, awarding grants to accelerate development and production of new technologies for influenza vaccines within the United States, and assisting state and local government pandemic planning efforts. However, federal government leadership roles and responsibilities for preparing for and responding to a pandemic continue to evolve, and will require further clarification and testing before the relationships of the many leadership positions are well understood. The Strategy and Plan do not specify how the leadership roles and responsibilities will work in addressing the unique characteristics of an influenza pandemic, which could occur simultaneously in multiple locations and over a long period. A pandemic could extend well beyond health and medical boundaries, affecting critical infrastructure, the movement of goods and services across the nation and the globe, and economic and security considerations. Although the Department of Health and Human Services' (HHS) Secretary is to lead the public health and medical response and the Department of Homeland Security's (DHS) Secretary is to lead overall nonmedical support and response actions, the Plan does not clearly address these simultaneous responsibilities or how these roles are to work together, particularly over an extended period and at multiple locations across the country. In addition, the Secretary of DHS has designated a national Principal Federal Official (PFO) to facilitate pandemic coordination as well as five regional PFOs and five regional Federal Coordinating Officers. Most of these leadership roles and responsibilities have not been tested under pandemic scenarios, leaving it unclear how they will work. Because initial actions may help limit the spread of an influenza virus, the effective exercise of shared leadership roles and responsibilities could have substantial consequences. However, only one national multisector pandemic-related exercise has been held and that was prior to the issuance of the Plan. While the Strategy and Plan are an important first step in guiding national preparedness, they do not fully address all six characteristics of an effective national strategy. Specifically, they fully address only one of the six characteristics, by reflecting a clear description and understanding of problems to be addressed, and do not address one characteristic because the documents do not describe the financial resources needed to implement actions. Although the other characteristics are partially addressed, important gaps exist that could hinder the ability of key stakeholders to effectively execute their responsibilities, including state and local jurisdictions that will play crucial roles in preparing for and responding to a pandemic were not directly involved in developing the Plan, relationships and priorities among actions were not clearly described, performance measures focused on activities that are not always linked to results; insufficient information is provided about how the documents are integrated with other key related plans, and no process is provided for monitoring and reporting on progress. Tue, 14 Aug 2007 00:00:00 -0400 http://www.gao.gov/new.items/d071142t.pdf The Federal Emergency Management Agency (FEMA) within the Department of Homeland Security (DHS) faces the simultaneous challenges of preparing for the season and implementing the reorganization and other provisions of the Post-Katrina Emergency Management Reform Act of 2006. The Act stipulated major changes to FEMA that were intended to enhance its preparedness for and response to catastrophic and major disasters. As GAO has reported, FEMA and DHS face continued challenges, including clearly defining leadership roles and responsibilities, developing necessary disaster response capabilities, and establishing accountability systems to provide effective services while protecting against waste, fraud, and abuse. This testimony (1) summarizes GAO's findings on these challenges and FEMA's and DHS's efforts to address them; and (2) discusses several disaster management issues for continued congressional attention. Effective disaster preparedness and response require defining what needs to be done, where and by whom, how it needs to be done, and how well it should be done. GAO analysis following Hurricane Katrina showed that improvements were needed in leadership roles and responsibilities, development of the necessary disaster capabilities, and accountability systems that balance the need for fast, flexible response against the need to prevent waste, fraud, and abuse. To facilitate rapid and effective decision making, legal authorities, roles and responsibilities, and lines of authority at all government levels must be clearly defined, effectively communicated, and well understood. Adequacy of capabilities in the context of a catastrophic or major disaster are needed--particularly in the areas of (1) situational assessment and awareness; (2) emergency communications; (3) evacuations; (4) search and rescue; (5) logistics; and (6) mass care and shelter. Implementing controls and accountability mechanisms helps to ensure the proper use of resources. FEMA has initiated reviews and some actions in each of these areas, but their operational impact in a catastrophic or major disaster has not yet been tested. Some of the targeted improvements, such as a completely revamped logistics system, are multiyear efforts. Others, such as the ability to field mobile communications and registration-assistance vehicles, are expected to be ready for the 2007 hurricane season. The Comptroller General has suggested one area for fundamental reform and oversight is ensuring a strategic and integrated approach to prepare for, respond to, recover, and rebuild after catastrophic events. FEMA enters the peak of the 2007 hurricane season as an organization in transition working simultaneously to implement the reorganization required by the Post-Katrina Reform Act and moving forward on initiatives to address the deficiencies identified by the post-Katrina reviews. This is an enormous challenge. In the short-term, Congress may wish to consider several specific areas for immediate oversight. These include (1) evaluating the development and implementation of the National Preparedness System, including preparedness for natural disasters, terrorist incidents, and an influenza pandemic; (2) assessing state and local capabilities and the use of federal grants to enhance those capabilities; (3) examining regional and multi-state planning and preparation; (4) determining the status and use of preparedness exercises; and (5) examining DHS polices regarding oversight assistance. Tue, 31 Jul 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07696.pdf An influenza pandemic could impair the military's readiness, jeopardize ongoing military operations abroad, and threaten the day-to-day functioning of the Department of Defense (DOD) due to a large percentage of sick or absent personnel. GAO was asked to examine DOD's pandemic influenza planning and preparedness efforts. GAO previously reported that DOD had taken numerous actions to prepare departmentwide, but faced four management challenges as it continued its efforts. GAO made recommendations to address these challenges and DOD generally concurred with them. This report focuses on DOD's combatant commands (COCOM) and addresses (1) actions the COCOMs have taken to prepare and (2) management challenges COCOMs face going forward. GAO reviewed guidance, plans, and after-action reports and interviewed DOD officials and more than 200 officials at the 9 COCOMs. COCOMs have taken numerous management and operational actions to prepare for an influenza pandemic, and the COCOMs' efforts are evolving. Each of DOD's nine COCOMs has established or intends to establish a working group to prepare for an influenza pandemic. Additionally, eight of the nine COCOMs have developed or are developing a pandemic influenza plan. Half of the COCOMs have conducted exercises to test their pandemic influenza plans and several are taking steps to address lessons learned. Five of the nine COCOMs have started to use various media, training programs, and outreach events to inform their personnel about pandemic influenza. Each of the geographic COCOMs has worked or plans to work with nations in its area of responsibility to raise awareness about and assess capabilities for responding to avian and pandemic influenza. Although COCOMs have taken numerous actions, GAO identified three management challenges that may prevent the COCOMs from being fully prepared to effectively protect personnel and perform missions during an influenza pandemic, two of which are related to issues GAO previously recommended that DOD address. First, the roles, responsibilities, and authorities of key organizations relative to others involved in DOD's planning efforts remained unclear in part due to the continued lack of sufficiently detailed guidance from the Secretary of Defense or his designee. As a result, the unity and cohesiveness of DOD's efforts could be impaired and the potential remains for confusion and gaps or duplication in actions taken by the COCOMs relative to the military services and other DOD organizations, such as in completing actions assigned to DOD in the Implementation Plan for the National Strategy for Pandemic Influenza. Second, GAO identified a disconnect between the COCOMs' planning and preparedness activities and resources, including funding and personnel, to complete these activities, in part, because DOD's guidance does not identify the resources required to complete these activities. The continued lack of a link between planning and preparedness activities and resources may limit the COCOMs' ability to effectively prepare for and respond to an influenza pandemic, including COCOMs' ability to exercise pandemic influenza plans in the future. Third, GAO identified factors that are beyond the COCOMs' control--such as limited detailed guidance from other federal agencies on support expected from DOD, lack of control over DOD's stockpile of antivirals, limited information on decisions that other nations may make during an influenza pandemic, reliance on civilian medical providers for medical care, and reliance on military services for medical materiel--that they have not yet fully planned how to mitigate. While GAO recognizes the challenge of pandemic influenza planning, not yet developing options to mitigate the effects of factors that are beyond their control may place at risk the COCOM commanders' ability to protect their personnel and perform missions during an influenza pandemic. For example, if a nation decides to close its borders at the start of a pandemic, COCOMs and installations may not be able to obtain needed supplies, such as antivirals. Wed, 20 Jun 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07604.pdf Since 2003, a global epidemic of avian influenza has raised concern about the risk of an influenza pandemic among humans, which could cause millions of deaths. The United States and its international partners have begun implementing a strategy to forestall (prevent or delay) a pandemic and prepare to cope should one occur. Disease experts generally agree that the risk of a pandemic strain emerging from avian influenza in a given country varies with (1) environmental factors, such as disease presence and certain high-risk farming practices, and (2) preparedness factors, such as a country's capacity to control outbreaks. This report describes (1) U.S. and international efforts to assess pandemic risk by country and prioritize countries for assistance and (2) steps that the United States and international partners have taken to improve the ability to forestall a pandemic. To address these objectives, we interviewed officials and analyzed data from U.S. agencies, international organizations, and nongovernmental experts. The U.S. and international agencies whose efforts we describe reviewed a draft of this report. In general, they concurred with our findings. Several provided technical comments, which we incorporated as appropriate. Assessments by U.S. agencies and international organizations have identified widespread risks of the emergence of pandemic influenza and the United States has identified priority countries for assistance, but information gaps limit the capacity for comprehensive comparisons of risk levels by country. Several assessments we examined, which have considered environmental or preparedness-related risks or both, illustrate these gaps. For example, a U.S. Agency for International Development (USAID) assessment categorized countries according to the level of environmental risk--considering factors such as disease presence and the likelihood of transmission from nearby countries, but factors such as limited understanding of the role of poultry trade or wild birds constrain the reliability of the conclusions. Further, USAID, the State Department, and the United Nations have administered questionnaires to assess country preparedness and World Bank-led missions have gathered detailed information in some countries, but these efforts do not provide a basis for making comprehensive global comparisons. Efforts to get better information are under way but will take time. The U.S. Homeland Security Council has designated priority countries for assistance, and agencies have further identified several countries as meriting the most extensive efforts, but officials acknowledge that these designations are based on limited information. The United States has played a prominent role in global efforts to improve avian and pandemic influenza preparedness, committing the greatest share of funds and creating a framework for managing its efforts. Through 2006, the United States had committed about $377 million, 27 percent of the $1.4 billion committed by all donors. USAID and the Department of Health and Human Services have provided most of these funds for a range of efforts, including stockpiles of protective equipment and training foreign health professionals in outbreak response. The State Department coordinates international efforts and the Homeland Security Council monitors progress. More than a third of U.S. and overall donor commitments have gone to individual countries, with more than 70 percent of those going to U.S. priority countries. The U.S. National Strategy for Pandemic Influenza Implementation Plan provides a framework for U.S. international efforts, assigning agencies specific action items and specifying performance measures and time frames for completion. The Homeland Security Council reported in December 2006 that all international actions due to be completed by November had been completed, and provided evidence of timely completion for the majority of those items. Wed, 20 Jun 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07609.pdf Congress has raised concerns over emergency management in school districts, with a particular interest in how federal agencies provide assistance to school districts. GAO was asked to assess (1) the roles of federal and state governments and school districts in establishing requirements and providing resources to school districts for emergency management planning, (2) what school districts have done to plan and prepare for emergencies, and (3) the challenges, if any, school districts have experienced in planning for emergencies, and communicating and coordinating with first responders, parents, and students. To obtain this information, GAO interviewed federal officials, surveyed a stratified random sample of all public school districts, surveyed state education agencies and state administering agencies, conducted site visits to school districts, and reviewed relevant documents. Although there are no federal laws requiring all school districts to have emergency management plans, most states and school districts reported having requirements for such planning, and federal and state governments and school districts provide financial and other resources. Thirty-two states reported having laws or other policies requiring school districts to have emergency management plans. The Departments of Education (Education) and Homeland Security (DHS) and state governments as well as school districts provide funding for emergency management planning in schools. DHS awards grants to states and local jurisdictions that may provide some of these funds to school districts and schools for emergency management planning. However, DHS program guidance for certain grants does not clearly identify school districts as entities to which state and local governments may disburse grant funds. Thus, states receiving DHS funding may not be aware that such funding could be allocated to school districts or schools. Most school districts have taken federally recommended steps to plan and prepare for emergencies, including the development of emergency management plans, but many plans do not include recommended practices. Based on GAO's survey of school districts, most school districts, those with and without plans, have undertaken a variety of recommended practices to prepare for emergencies such as conducting school drills and exercises. In addition, based on GAO's survey of school districts, an estimated 95 percent of all school districts have written emergency management plans, but the content varies. While most school districts have procedures in their plans for staff roles and responsibilities, for example, school districts have not widely employed such procedures as, academic instruction via local radio or television, for continuing student education in the event of an extended school closure, such as might occur during a pandemic. Likewise, while many districts have procedures for special needs students, GAO found during site visits that some of these procedures may not fully ensure the safety of these students in an emergency. Finally, while most school districts practice their emergency management plans annually within the school community, GAO estimates that over one-quarter of school districts have never trained with any first responders and over two-thirds of school districts do not regularly train with community partners on how to implement their school district emergency management plans. Many school districts experience challenges in planning for emergencies, and some school districts face difficulties in communicating and coordinating with first responders and parents, but most do not have such challenges with students. Based on GAO's survey of school districts, in many school districts officials struggle to balance priorities related to educating students and other administrative responsibilities with activities for emergency management and consider a lack of equipment, training for staff, and personnel with expertise in the area of emergency planning as challenges. In an estimated 39 percent of school districts with emergency management plans, officials experienced a lack of partnerships, limited time or funding to plan, or lack of interoperability between equipment used by school districts and first responders. In interviews, about half of the officials in the 27 school districts GAO visited reported difficulty in ensuring that parents received consistent information from the district during an emergency. Tue, 12 Jun 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07652.pdf A highly pathogenic strain of avian influenza (AI) has spread to nearly 60 countries over the past few years, killing millions of birds and more than 170 humans. Controlling the virus in poultry is key to reducing the risk of a human pandemic. The Department of Agriculture (USDA) is responsible for planning for AI outbreaks in poultry, with states' assistance. The Department of Homeland Security (DHS) is responsible for coordinating the federal response for certain emergencies and developing policy documents that serve as a basis for national emergency planning. GAO described the steps USDA is taking to prepare for highly pathogenic AI and identified key challenges. GAO reviewed response plans, statutes, and regulations; visited poultry operations; interviewed federal, state, and industry officials in five states that experienced outbreaks; and reviewed 19 state plans. USDA is taking important steps to prepare for highly pathogenic AI. For example, the department has established mechanisms to prevent infected poultry and products from being imported and has developed several surveillance programs to detect AI. In addition, USDA is developing response plans specific to highly pathogenic AI and has begun conducting exercises to test these plans. Moreover, USDA is building a National Veterinary Stockpile to maintain critical supplies, including equipment to protect responders. Finally, USDA has launched various AI research projects, including one to explore why the virus causes disease and death in some domestic poultry and wild birds but not in others. While USDA has made important strides, incomplete planning at the federal and state levels, as well as several unresolved issues, could slow response. First, USDA is not planning for the lead coordinating role that DHS would assume if an outbreak among poultry occurred that is sufficient in scope to warrant various federal disaster declarations. GAO's prior work has shown that roles and responsibilities must be clearly defined and understood to facilitate rapid and effective decision making. Moreover, USDA response plans do not identify the capabilities needed to carry out the critical tasks associated with an outbreak scenario--that is, the entities responsible for carrying them out, the resources needed, and the provider of those resources. Furthermore, some state plans lack important components that could facilitate rapid AI containment, which is problematic because states typically lead initial response efforts. Finally, there are several unresolved issues that, absent advance consideration, could hinder response. For example, controlling an outbreak among birds raised in backyards, such as for hobby, remains particularly difficult because federal and state officials generally do not know the numbers and locations of these birds. In addition, USDA has not estimated the amount of antiviral medication that it would need during an outbreak or resolved how to provide such supplies in a timely manner. According to federal guidance, poultry workers responding to an outbreak of highly pathogenic AI should take antiviral medication to protect them from infection. Mon, 11 Jun 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07821t.pdf Events such as the recent shootings by armed intruders in schools across the nation, natural disasters, the terrorist attacks of September 11, 2001, and potential pandemics have heightened awareness for the need for school districts to be prepared to address a range of emergencies within and outside of schools buildings. Congress has raised concerns over school preparedness, with a particular interest in how federal agencies provide assistance to school districts. This testimony discusses preliminary findings related to GAO's review of emergency management in school districts, including (1) the roles of federal and state governments in establishing requirements and providing resources to school districts for emergency management planning, (2) what school districts have done to plan and prepare for emergencies, and (3) the challenges school districts have experienced in planning for emergencies, and communicating and coordinating with first responders, parents, and students. To obtain this information, GAO interviewed federal officials, surveyed a stratified random sample of all public school districts, surveyed state agencies that administer federal grants that can be used for school emergency management planning, conducted site visits to school districts, and reviewed relevant documents. Federal and state governments have a role in supporting emergency management in school districts. While no federal laws require school districts to have emergency management plans, 32 states reported having laws or policies requiring school districts to have such plans. The Departments of Education and Homeland Security (DHS) provide funding for emergency management planning in schools. However, some DHS program guidance, for specific grants, does not clearly identify school districts as entities to which state and local governments may disburse grant funds. Thus, states receiving this funding may be uncertain as to whether such funding can be allocated to school districts or schools and therefore may not have the opportunity to benefit from this funding. States also provide funding and other resources to school districts to assist them in planning for emergencies. School districts have taken steps to plan for a range of emergencies, as most have developed multi-hazard emergency management plans; however some plans and activities do not address federally recommended practices. For example, based on GAO's survey of a sample of public school districts, an estimated 56 percent of all school districts have not employed any procedures in their plans for continuing student education in the event of an extended school closure, such as might occur during a pandemic, and many do not include procedures for special needs students. Fewer than half of districts with emergency plans involve community partners when developing and updating these plans. Finally, school districts are generally not training with first responders or community partners on how to implement their school district emergency plans. Many school district officials said that they experience challenges in planning for emergencies and some school districts face difficulties in communicating and coordinating with first responders and parents, but most said that they do not experience challenges in communicating with students. For example, in an estimated 62 percent of districts, officials identified challenges stemming from a lack of equipment, training for staff, and personnel with expertise in the area of emergency planning as obstacles to implementing recommended practices. Thu, 17 May 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07835t.pdf As a new hurricane season approaches, the Federal Emergency Management Agency (FEMA) within the Department of Homeland Security (DHS) faces the simultaneous challenges of preparing for the season and implementing the reorganization and other provisions of the Post-Katrina Emergency Management Reform Act of 2006. The Act stipulates major changes to FEMA intended to enhance its preparedness for and response to catastrophic and major disasters. As GAO has reported, FEMA and DHS face continued challenges, including clearly defining leadership roles and responsibilities, developing necessary disaster response capabilities, and establishing accountability systems to provide effective services while protecting against waste, fraud, and abuse. This testimony (1) summarizes GAO's findings on these challenges and FEMA's and DHS's efforts to address them; and (2) discusses several disaster management issues for continued congressional attention. Effective disaster preparedness and response require defining what needs to be done, where and by whom, how it needs to be done, and how well it should be done. GAO analysis following Hurricane Katrina showed that improvements were needed in leadership roles and responsibilities, development of the necessary disaster capabilities, and accountability systems that balance the need for fast, flexible response against the need to prevent waste, fraud, and abuse. To facilitate rapid and effective decision making, legal authorities, roles and responsibilities, and lines of authority at all government levels must be clearly defined, effectively communicated, and well understood. Adequacy of capabilities in the context of a catastrophic or major disaster are needed--particularly in the areas of (1) situational assessment and awareness; (2) emergency communications; (3) evacuations; (4) search and rescue; (5) logistics; and (6) mass care and shelter. Implementing controls and accountability mechanisms helps to ensure the proper use of resources. FEMA has initiated reviews and some actions in each of these areas, but their operational impact in a catastrophic or major disaster has not yet been tested. Some of the targeted improvements, such as a completely revamped logistics system, are multiyear efforts. Others, such as the ability to field mobile communications and registration-assistance vehicles, are expected to be ready for the coming hurricane season. The Comptroller General has suggested one area for fundamental reform and oversight is ensuring a strategic and integrated approach to prepare for, respond to, recover, and rebuild after catastrophic events. FEMA enters the 2007 hurricane season as an organization in transition working simultaneously to implement the reorganization required by the Post-Katrina Reform Act and moving forward on initiatives to address the deficiencies identified by the post-Katrina reviews. This is an enormous challenge. In the short-term, Congress may wish to consider several specific areas for immediate oversight. These include (1) evaluating the development and implementation of the National Preparedness System, including preparedness for natural disasters, terrorist incidents, and an influenza pandemic; (2) assessing state and local capabilities and the use of federal grants to enhance those capabilities; (3) examining regional and multi-state planning and preparation; (4) determining the status and use of preparedness exercises; and (5) examining DHS polices regarding oversight assistance. Tue, 15 May 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07515.pdf The Office of Personnel Management (OPM), which provides direction to the federal executive boards (FEBs), is now emphasizing that in the post-9/11 environment, the boards have a transformed emergency support role. The report discusses the boards' emergency preparedness roles and responsibilities and their potential role in preparing for and responding to pandemic influenza. GAO selected 14 of the 28 FEBs for review because they coordinate the greatest number of federal employees or had recent emergency management experience. Located outside Washington, D.C., in 28 cities with a large federal presence, the federal executive boards (FEB) are interagency coordinating groups designed to strengthen federal management practices, improve intergovernmental relations, and participate as a unified federal force in local civic affairs. Created by a Presidential Directive in 1961, the boards are composed of the federal field office agency heads and military commanders in their cities. Although membership by agency heads on the boards is required, active participation is voluntary in practice. The boards generally have staff of one or two full-time personnel, including an executive director. The FEBs have no congressional charter and receive no congressional appropriation but rather rely on voluntary contributions from their member agencies. Although the boards are not intended to be first responders, the regulations that guide the FEBs state that emergency operations is one of their functions. The Office of Personnel Management (OPM) and the FEBs have designated emergency preparedness, security, and employee safety as a core function of the boards and are continuing to work on a strategic plan that will include a common set of performance standards for their emergency support activities. All of the selected FEBs were performing emergency activities, such as organizing preparedness training, and FEB representatives and Federal Emergency Management Agency (FEMA) officials reported that these activities mutually advanced their missions. The FEBs, however, face key challenges in carrying out their emergency support role. First, their role is not defined in national emergency plans. According to several FEMA officials, FEBs could carry out their emergency support role more effectively if it was included in national emergency management plans. The framework within which the FEBs operate with member agencies and OPM also poses challenges in holding the boards accountable for their emergency support function. In addition, the funding sources for the boards are uncertain, affecting their ability to plan for and commit to providing emergency support services. Despite these challenges, the nature of pandemic influenza, which presents different concerns than localized natural disasters, makes the FEBs a particularly valuable asset in pandemic preparedness and response. Many of the selected boards had already hosted pandemic preparedness events, which included their member agencies and local community organizations. With the greatest burden of pandemic response resting on the local communities, the FEBs' outreach and their ability to coordinate across organizations suggest that they may be an important resource in preparing for and responding to a pandemic. Fri, 04 May 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07399.pdf This is GAO's third report since the September 11 terrorist attacks that assesses progress that market participants and regulators have made to ensure the security and resiliency of our securities markets. This report examined (1) actions taken to improve the markets' capabilities to prevent and recover from attacks; (2) actions taken to improve disaster response and increase telecommunications resiliency; and (3) financial regulators' efforts to ensure market resiliency. GAO inspected physical and electronic security measures and business continuity capabilities using regulatory, government, and industry-established criteria and discussed improvement efforts with broker dealers, banks, regulators, telecommunications carriers, and trade associations. The critical securities markets organizations GAO reviewed have acted to significantly reduce the likelihood of physical disasters disrupting the functioning of U.S. securities markets. As of January 2007, the seven critical exchanges, markets, clearing organizations, and payment processors GAO reviewed have the capability of performing their critical functions at sites that are geographically dispersed from their primary sites. These organizations were also preparing plans to reduce the likelihood that a disease pandemic will disrupt their critical operations, although not all had fully completed such efforts. They also improved their physical and information security measures, including by taking actions that GAO identified during this review. Although key securities trading staff remain concentrated in single locations, the broker-dealers and clearing services banks that account for significant trading volumes and that GAO reviewed have increased the distances between their sites for primary and backup operations for clearance and settlement activities and established dispersed backup trading locations. Various private and public sector groups continued to enhance the preparedness of the financial sector, although resolving vulnerabilities in the telecommunications infrastructure remains a challenge. Securities industry organizations have continued to conduct annual industrywide tests of financial market participants' backup site operating capabilities, and key trading and clearing organizations are increasingly using communications networks that are less vulnerable to disruption to transmit information. After attempts to assist individual financial market participants to determine whether their own telecommunications lines were routed through single paths or switches proved difficult, regulators are assisting efforts to develop automated systems for identifying circuit paths. In response to concerns over whether the telecommunications infrastructure can absorb the increased demand likely to result from large numbers of organizations and individuals seeking to telecommute during a pandemic, financial regulators and market participants are assisting government efforts to model such events and develop potential solutions. To improve market resiliency, financial regulators established goals for prompt recovery of critical clearing activities after disasters and have been conducting examinations to ensure market participants' compliance. Securities regulators also set goals and are examining securities markets' readiness to resume trading and plan to do more focused reviews of individual broker-dealer capabilities. The Securities and Exchange Commission (SEC) also has improved its program for overseeing operations issues at market and clearing organizations, including increasing its staffing levels and expertise. Securities and banking regulators have been actively addressing pandemic issues, but could better ensure that market participants prepare complete plans and have sufficient time to train employees and test these plans, by providing formal expectations that plans address even severe outbreaks and set dates for completing such plans. Thu, 29 Mar 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07485r.pdf The September 11, 2001, terrorist attacks, the anthrax incidents during the fall of 2001, Hurricane Katrina, and concerns about the possibility of an influenza pandemic have raised public awareness and concerns about the nation's public health and medical systems' ability to respond to bioterrorist events and other public health emergencies. From 2002 to 2006, the Congress appropriated about $6.1 billion to the Department of Health and Human Services (HHS) to support activities to strengthen state and local governments' emergency preparedness capabilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Preparedness and Response Act). HHS has distributed funds annually to 62 recipients, including all 50 states and 4 large municipalities, through cooperative agreements under two programs--the Centers for Disease Control and Prevention's (CDC) Public Health Emergency Preparedness Program, and the Health Resources and Services Administration's (HRSA) National Bioterrorism Hospital Preparedness Program. The common goal of CDC's and HRSA's preparedness programs is to improve state and local preparedness to respond to bioterrorism and other large-scale public health emergencies, such as natural disasters or outbreaks of infectious disease. Annually, both CDC and HRSA develop and issue program guidance for recipients that describes activities necessary to improve their ability to respond to bioterrorism and other public health emergencies and sets out requirements for measuring their performance. Each recipient is required to submit periodic reports that track progress in improving their preparedness. As a result of the nation's ineffective response to Hurricane Katrina and the need to prepare for a possible influenza pandemic, members of the Congress have raised questions about CDC's and HRSA's efforts to monitor the progress of their preparedness programs. Because of these questions, we are reporting on (1) how CDC's and HRSA's performance measurement systems have evolved and (2) how CDC and HRSA are using these systems to measure the progress of their preparedness programs. Since 2002, CDC's and HRSA's performance measurements have evolved from measuring capacity to assessing capability. Early in their programs, both agencies used markers or values that they called benchmarks to measure capacity-building efforts, such as purchasing equipment and supplies and acquiring personnel. These benchmarks were developed from activities authorized in the Preparedness and Response Act. In 2002, CDC established 14 benchmarks, such as requiring each recipient to designate an executive director of the bioterrorism and response program, establish a bioterrorism advisory committee, and develop a statewide response plan. From 2003 to 2005, CDC further developed its performance measurements by obtaining input from stakeholders to make a transition from using benchmarks focused on capacities to using performance measures focused on capabilities, such as whether personnel have been trained and can appropriately use equipment. In 2006, CDC continued to work with stakeholders to refine its performance measures. At the beginning of its program in 2002, HRSA established 5 benchmarks, such as requiring each recipient to designate a coordinator for bioterrorism planning, establish a hospital preparedness committee, and develop a plan for hospitals to respond to a potential epidemic. From 2003 to 2005, HRSA modified existing benchmarks and added new ones, such as training benchmarks, based on the existing legislation and input from stakeholders. In 2006, HRSA convened an expert panel to propose a set of performance measures focused on capabilities. CDC and HRSA officials told us they will continue to face challenges as their performance measures evolve, such as gaining consensus among stakeholders in light of minimal scientific data about public health and hospital emergency preparedness. CDC and HRSA use data from recipients' reports and site visits to monitor recipients' progress in improving their ability to respond to bioterrorism events and other public health emergencies. CDC and HRSA project officers use performance measurement data from recipients' required progress reports, along with site visits, to monitor progress and provide feedback about whether individual recipients have accomplished activities related to their ability to respond to bioterrorism events and other public health emergencies. Currently, there are no standard analyses or reports that enable CDC and HRSA to compare data across recipients to measure collective progress, compare progress across recipients' programs, or provide consistent feedback to recipients. However, in mid to late 2006 both agencies began developing formal data analysis programs that are intended to validate recipient-reported data and assist in generating standardized reports. According to CDC officials, CDC plans to finish validation projects by August 2007 and then develop routine reports summarizing individual recipient and national progress. In addition, CDC plans to issue a report by the end of 2007 providing a "snapshot" of the progress recipients have made in building emergency readiness capacity and addressing how CDC will measure capability in the future. However, because of the expected move of HRSA's program to a different HHS office in 2007, its schedule for finishing data validation was tentative at the time we briefed your staff. Furthermore, due to the expected move, HRSA officials said at that time that decisions about whether to issue a report in 2007 on recipients' progress also had not been made. Fri, 23 Mar 2007 00:00:00 -0400 http://www.gao.gov/new.items/d07395t.pdf The Post-Katrina Emergency Management Reform Act of 2006 stipulates major changes to the Federal Emergency Management Agency (FEMA) within the Department of Homeland Security (DHS) to improve the agency's preparedness for and response to catastrophic disasters. For example, the act establishes a new mission for and new leadership positions within FEMA. As GAO has reported, DHS faces continued challenges, including clearly defining leadership roles and responsibilities, developing necessary disaster response capabilities, and establishing accountability systems to provide effective response while also protecting against waste, fraud, and abuse. This testimony discusses the extent to which DHS has taken steps to overcome these challenges This testimony summarizes earlier GAO work on: (1) leadership, response capabilities, and accountability controls; (2) organizational changes provided for in the Post-Katrina Reform Act; and (3) disaster management issues for continued Congressional attention. GAO reported in the aftermath of Hurricane Katrina that DHS needs to more effectively coordinate disaster preparedness, response, and recovery efforts. GAO analysis showed improvements were needed in leadership roles and responsibilities, development of necessary disaster capabilities, and accountability systems that balance the need for fast, flexible response with the need to prevent waste, fraud, and abuse. To facilitate rapid and effective decision making, legal authorities, roles and responsibilities, and lines of authority at all government levels must be clearly defined, effectively communicated, and well understood. Improved capabilities were needed for catastrophic disasters--particularly in the areas of (1) situational assessment and awareness; (2) emergency communications; (3) evacuations; (4) search and rescue; (5) logistics; and (6) mass care and sheltering. Effectively implementing the provisions of the Post-Katrina Reform Act will address many of these issues, and FEMA has initiated reviews and some actions in each of these areas. But their operational impact in a major disaster has not yet been tested. As a result of its body of work, GAO's recommendations included that DHS (1) rigorously re-test, train, and exercise its recent clarification of the roles, responsibilities, and lines of authority for all levels of leadership; (2) direct that more robust and detailed operational implementation plans support the National Response Plan (NRP); (3) provide guidance and direction for all planning, training, and exercises to ensure such activities fully support preparedness, response, and recovery responsibilities at a jurisdictional and regional basis; (4) take a lead in monitoring federal agencies' efforts to prepare to meet their responsibilities under the NRP and the interim National Preparedness Goal; and (5) use a risk management approach in making its investment decisions. We also recommended that Congress give federal agencies explicit authority to take action to prepare for all types of catastrophic disasters when there is warning. In his oversight letter to Congress, the Comptroller General suggested that one area needing fundamental reform and oversight is ensuring a strategic and integrated approach to prepare for, respond to, recover, and rebuild from catastrophic events. Congress may wish to consider several specific areas for immediate oversight. These include (1) evaluating development and implementation of the National Preparedness System, including preparedness for an influenza pandemic; (2) assessing state and local capabilities and the use of federal grants to enhance those capabilities; (3) examining regional and multi-state planning and preparation; (4) determining the status of preparedness exercises; and (5) examining DHS polices regarding oversight assistance. Fri, 09 Mar 2007 00:00:00 -0500 http://www.gao.gov/new.items/d061042.pdf An influenza pandemic would be of global and national significance and could affect large numbers of Department of Defense (DOD) personnel, seriously challenging DOD's readiness. GAO was asked to examine DOD's pandemic influenza preparedness efforts. This report focuses on DOD's planning for its workforce, specifically (1) actions DOD has taken to prepare and (2) challenges DOD faces going forward. GAO analyzed guidance, contracts, and plans, and met with DOD officials. DOD had taken a number of actions since September 2004 to prepare for an influenza pandemic, and its planning efforts continue to evolve. The Implementation Plan for the National Strategy for Pandemic Influenza, released in May 2006, tasked each federal department to develop its own implementation plan that details how it will carry out its responsibilities as outlined in the national plan and how it will prepare its workforce. DOD established working groups for its pandemic influenza planning efforts, including the Pandemic Influenza Task Force, which included representatives from across the department, including the Offices of the Assistant Secretary of Defense (ASD) for Homeland Defense, ASD for Health Affairs, ASD for Special Operations and Low Intensity Conflict, and the Joint Chiefs of Staff. In addition, the Office of the ASD for Health Affairs developed guidance that provided tasks for the Office of the Secretary of Defense, military departments, installation commanders, and others to complete to prepare for a pandemic. Further, several entities within DOD drafted plans and guidance, and DOD had taken other important steps, such as establishing Web sites, stockpiling vaccines and antivirals, and initiating projects to assist other nations with their preparedness efforts. Going forward, DOD faces four management challenges that it needs to address as it shifts its focus to the department as a whole. First, at the time of GAO's review, neither the Secretary of Defense nor the Deputy Secretary of Defense had yet issued guidance defining lead and supporting roles and responsibilities with clear lines of authority, oversight mechanisms, and goals and performance measures for DOD's influenza pandemic planning efforts. The lack of these accountability mechanisms over time may hamper the leadership's ability to ensure that planning efforts across the department are progressing as intended. Second, DOD had not yet requested funding for its pandemic influenza preparedness efforts linked to departmentwide goals. Therefore, it is unclear whether DOD can address the tasks assigned to it in the national implementation plan and pursue its own preparedness efforts for its workforce departmentwide within current resources. Third, DOD had not yet fully defined or communicated departmentwide which types of personnel--military and civilian personnel, contractors, beneficiaries, and dependents--it plans to include in its distribution of vaccines and antivirals. Fourth, DOD had not yet fully developed its communications strategy or communicated information to its personnel departmentwide on what actions to take in the event of an influenza pandemic. Also, DOD had not yet developed a plan to communicate information on the safety and efficacy of vaccines and antivirals, if DOD decides to dispense them. While DOD established Web sites with some information on pandemic influenza, GAO identified some unevenness across the department in terms of the information personnel received. A comprehensive and effective communications strategy could ensure that DOD's personnel departmentwide are aware of actions they should take in the event of an influenza pandemic. Thu, 21 Sep 2006 00:00:00 -0400 http://www.gao.gov/new.items/d06740t.pdf To ensure that essential government services are available in emergencies, federal agencies are required to develop continuity of operations (COOP) plans. The Federal Emergency Management Agency (FEMA), within the Department of Homeland Security (DHS), is responsible for providing guidance to agencies on developing such plans. Its guidance states that in their continuity planning, agencies should consider the use of telework--that is, work performed at an employee's home or at a work location other than a traditional office. The Office of Personnel Management (OPM) recently reported that 43 agencies have identified staff eligible to telework, and that more than 140,000 federal employees used telework in 2004. OPM also reported that many government operations can be carried out in emergencies using telework. For example, telework appears to be an effective strategy for responding to a pandemic--a global outbreak of disease that spreads easily from person to person and causes serious illness and death worldwide. In previous work, GAO identified steps that agencies should take to effectively use telework during an emergency. GAO was asked to testify on how agencies are addressing the use of telework in their continuity planning, which is among the topics discussed in a report being released today (GAO-06-713). Although agencies are not required to use telework in continuity planning, 9 of the 23 agencies surveyed reported plans for essential team members to telework during a COOP event, compared to 3 in GAO's previous survey. However, few documented that they made the necessary preparations to effectively use telework during such an event. For example, only 1 agency documented that it had communicated this expectation to its emergency team members. One reason for the low levels of preparations reported is that FEMA has not provided specific guidance on preparations needed to use telework during emergencies. Recently, FEMA disseminated guidance to agencies on incorporating pandemic influenza considerations into COOP planning. Although this guidance suggests the use of telework during such an event, it does not address the steps agencies should take when preparing to use telework during an emergency. Without specific guidance, agencies are unlikely to adequately prepare their telework capabilities for use during a COOP event. In addition, inadequate preparations could limit the ability of nonessential employees to contribute to agency missions during extended emergencies, including pandemic influenza. In its report released today, GAO recommends, among other things, that FEMA establish a time line for developing, in consultation with the OPM, guidance on preparations needed for using telework during a COOP event. In commenting on a draft of the report, DHS partially agreed with GAO's recommendation and stated that FEMA will coordinate with OPM in developing a time line for further telework guidance. DHS also stated that both FEMA and OPM have provided telework guidance. However, as GAO's report stated, present guidance does not address the preparations federal agencies should make for using telework during emergencies. On May 3 the White House announced the release of an Implementation Plan in support of the National Strategy for Pandemic Influenza. This plan calls on OPM to work with DHS and other agencies to revise existing telework guidance and issue new guidance on human capital planning and COOP. The plan establishes an expectation that these actions will be completed within 3 months. If the forthcoming guidance does not require agencies to make necessary preparations for telework, agencies are unlikely to take all the steps necessary to ensure that employees will be able to effectively use telework to perform essential functions in extended emergencies, such as a pandemic influenza. Thu, 11 May 2006 00:00:00 -0400 http://www.gao.gov/new.items/d06221t.pdf Concern has been rising about the nation's preparedness to respond to vaccine shortages that could occur in future annual influenza seasons or during an influenza pandemic--a global influenza outbreak. Although the timing or extent of a future influenza pandemic cannot be predicted, studies suggest that its effect in the United States could be severe, and shortages of vaccine could occur. For the 2004-05 annual influenza season, the nation lost about half its expected influenza vaccine supply when one of two major manufacturers announced in October 2004 that it would not release any vaccine. GAO examined federal, state, and local actions taken in response to the shortage, including lessons learned. The nation's experience during the unexpected 2004-05 vaccine shortfall offers insights into some of the challenges that government entities will face in a pandemic. GAO was asked to provide a statement on lessons learned from the 2004-05 vaccine shortage and their relevance to planning and preparing for similar situations in the future, including an influenza pandemic. This statement is based on a GAO report, Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for Better Preparation (GAO-05-984), and on previous GAO reports and testimonies about influenza vaccine supply and pandemic preparedness. A number of lessons emerged from federal, state, and local responses to the 2004-05 influenza vaccine shortage that carry implications for handling future vaccine shortages in either an annual influenza season or an influenza pandemic. First, limited contingency planning slows response. At the start of the 2004-05 influenza season, when the supply shortfall became apparent, the nation lacked a contingency plan specifically to address severe shortages. The absence of such a plan led to delays and uncertainties on the part of state and local public health entities on how best to ensure access to vaccine by individuals at high risk of severe influenza-related complications. Second, streamlined mechanisms to expedite vaccine availability are key to an effective response. During the 2004-05 shortage, for example, federal purchases of vaccine licensed for use in other countries but not the United States were not completed in time to meet peak demand. Some states' experience also highlighted the importance of mechanisms to transfer available vaccine quickly and easily from one state to another. Third, effective response requires clear and consistent communication. Consistency among federal, state, and local communications is critical for averting confusion. State and local health officials also emphasized the value of updated information when responding to changing circumstances, using diverse media to reach diverse audiences, and educating providers and the public about prevention alternatives. Over the past 5 years, GAO has urged the Department of Health and Human Services (HHS) to complete its plan to prepare for and respond to an influenza pandemic. GAO has reported on the importance of planning to address critical issues such as how vaccine will be purchased and distributed; how population groups will be given priority for vaccination; and how federal resources should be deployed before the nation faces a pandemic. On November 2, 2005, HHS released its pandemic influenza plan. GAO did not have the opportunity to review the plan before issuing this statement to determine the extent to which the plan addresses these critical issues. Fri, 04 Nov 2005 00:00:00 -0500 http://www.gao.gov/new.items/d05984.pdf In early October 2004, the nation lost about half its expected influenza vaccine supply when one of two major manufacturers announced it would not release any vaccine for the 2004-05 season because of potential contamination. The Centers for Disease Control and Prevention (CDC) had earlier recommended vaccination for 188 million individuals, including those at high risk of severe complications from influenza (such as seniors and those with chronic conditions), and other groups (such as their close contacts). Although health officials took actions to distribute the limited supply of influenza vaccine, reports persisted of high-risk individuals and others in priority groups who could not find a vaccination, including those who were turned away and never returned when supplies became available. Such reports raised questions about the adequacy of U.S. preparedness to respond to significant vaccine shortages. GAO was asked to examine actions taken at federal, state, and local levels to ensure that high-risk individuals had access to influenza vaccine during the shortage, including any lessons learned. Federal, state, and local health officials took several actions beginning in October 2004 to help ensure that individuals at high risk of severe complications from influenza had access to vaccine. Federal officials, for example, quickly revised vaccination recommendations to target available vaccine to high-risk individuals and to other priority groups. Additional actions were aimed to distribute vaccine expeditiously and to communicate with providers and the public as events unfolded and vaccine supplies changed. Beginning in mid-December, health officials took steps to distribute additional vaccine, broadening recommendations on who should be vaccinated. Although these actions helped achieve vaccination rates approaching past levels for certain priority groups, such as those aged 65 years and older, several lessons emerged, including some that could help with future shortages. First, unless planning for problems is already in place, action is delayed. CDC's lack of a contingency plan contributed to delays and uncertainty about how to ensure that high-risk individuals had access to vaccine. Second, when actions occur late in the influenza season, they are likely to have little effect. Third, effective response requires communication that is both clear and consistent. CDC has taken a number of steps, including issuing interim guidelines in August 2005, to respond to possible future shortages. It is too early, however, to assess the effectiveness of these efforts in coordinating actions of federal, state, and local health agencies and others. In commenting on a draft of this report, HHS concurred with GAO's finding that contingency planning would improve response efforts, and the agency indicated that additional preparations were under way. Fri, 30 Sep 2005 00:00:00 -0400 http://www.gao.gov/new.items/d05652.pdf The events of September 11, 2001, have resulted in a greater focus on the role of first responders in carrying out the nation's emergency management efforts. The Department of Homeland Security (DHS) is the primary federal entity responsible for ensuring that first responders, such as police, fire, emergency medical, and public health personnel, have the capabilities needed to provide a coordinated, comprehensive response to any large-scale crisis. In the last 4 years DHS has awarded $11.3 billion to state and local governments to enhance capabilities, primarily to prevent, prepare for, respond to and recover from acts of terrorism. Presidential directives instruct DHS to develop a national all-hazards approach--preparing all sectors of society for any emergency event including terrorist attacks and natural or accidental disasters. This report addresses the following questions: (1) What actions has DHS taken to provide policies and strategies that promote the development of the all-hazards emergency management capabilities of first responders? (2) How do first responders' emergency management capabilities for terrorist attacks differ to capabilities needed for natural or accidental disasters? (3) What emphasis has DHS placed on funding awarded to state and local first responders to enhance all-hazards emergency management capabilities? DHS has undertaken three major policy initiatives aimed at creating a national, all-hazards coordinated and comprehensive response to large-scale incidents: (1) a national response plan (what needs to be done); (2) a command and management process (how it needs to be done); and (3) a national preparedness goal (how well it should be done). GAO reviewed these products and determined that each supports a national, all-hazards approach. DHS has developed plans to implement three related programs to enhance first responder capabilities: (1) to assess and report on the status of first responders' capabilities; (2) to prioritize national resource investments; and (3) to establish a national training and exercise program. Implementing these programs will likely pose a number of challenges for DHS including integrating internal and external assessment approaches, assessing state and local risks in a national context to effectively prioritize investments, and establishing common training requirements across responder disciplines. Because terrorist attacks share some common characteristics with natural and accidental disasters, 30 of DHS' 36 capabilities first responders need to support preparedness and response efforts are similar. GAO's analysis found that the baseline capabilities required for terrorist attacks and natural or accidental disasters are more similar for response and recovery and differ most for prevention. Because terrorist attacks are planned, intentional acts, all of DHS' prevention capabilities focus on terrorist attacks, while almost all other baseline capabilities focus on all hazards. Legislation and presidential directives call for DHS to place special emphasis on preparedness for terrorism and DHS has directed that the majority of first responder grant funding be used to enhance first responder capabilities to prevent, protect against, respond to, and recover from terrorist attacks. Nonetheless, grants funds can have all-hazards applications. Mon, 11 Jul 2005 00:00:00 -0400 http://www.gao.gov/new.items/d05863t.pdf Shortages of influenza vaccine in the 2004-05 and previous influenza seasons and mounting concern about recent avian influenza activity in Asia have raised concern about the nation's preparedness to deal with a worldwide influenza epidemic, or influenza pandemic. Although the extent of such a pandemic cannot be predicted, according to the Centers for Disease Control and Prevention (CDC), an agency within the Department of Health and Human Services (HHS), it has been estimated that in the absence of any control measures such as vaccination or antiviral drugs, a "medium-level" influenza pandemic could kill up to 207,000 people in the United States, affect from 15 to 35 percent of the U.S. population, and generate associated costs ranging from $71 billion to $167 billion in the United States. GAO was asked to discuss the challenges the nation faces in responding to the threat of an influenza pandemic, including the lessons learned from previous annual influenza seasons that can be applied to its preparedness and overall ability to respond to a pandemic. This testimony is based on GAO reports and testimony issued since 2000 on influenza vaccine supply, pandemic planning, emergency preparedness, and emerging infectious diseases and on current work examining the influenza vaccine shortage in the United States for the 2004-05 influenza season. The nation faces multiple challenges to prepare for and respond to an influenza pandemic. First, key questions about the federal role in purchasing and distributing vaccines during a pandemic remain, and clear guidance on potential priority groups is lacking in HHS's current draft of its pandemic preparedness plan. For example, the draft plan does not establish the actions the federal government would take to purchase or distribute vaccine during an influenza pandemic. In addition, as was highlighted in the nation's recent experience responding to the unexpected influenza vaccine shortage for the 2004-05 influenza season, clear communication of the nation's response plan will be a major challenge. During the 2004-05 influenza season, state health officials reported that mixed messages created confusion. For example, CDC advised vaccination for persons aged 65 and older, and at the same time a state advised vaccination for persons aged 50 and older. Further challenges include ensuring an adequate and timely supply of influenza vaccine and antiviral drugs, which can help prevent or mitigate the number of influenza-related deaths. Particularly given the length of time needed to produce vaccines, influenza vaccine may be unavailable or in short supply and might not be widely available during the initial states of a pandemic. Finally, the lack of sufficient hospital and health care workforce capacity to respond to an infectious disease outbreak may also affect response efforts during an influenza pandemic. Public health officials we spoke with said that a large-scale outbreak, such as an influenza pandemic, could strain the available capacity of hospitals by requiring entire hospital sections, along with their staff, to be used as isolation facilities. Thu, 30 Jun 2005 00:00:00 -0400 http://www.gao.gov/new.items/d05760t.pdf Vaccine shortages and distribution problems during the 2004-2005 influenza season raised concerns about the nation's ability to respond to a worldwide influenza epidemic--or influenza pandemic--which many experts believe to be inevitable. Some experts believe that the next pandemic could be spawned by the recurring avian influenza in Asia. If avian influenza strains directly infect humans and acquire the ability to be readily transmitted between people, a pandemic could occur. Modeling studies suggest that its effect in the United States could be severe, with one estimate from the Centers for Disease Control and Prevention (CDC) ranging from 89,000 to 207,000 deaths and from 38 million to 89 million illnesses. GAO was asked to discuss surveillance systems in place to identify and monitor an influenza pandemic and concerns about preparedness for and response to an influenza pandemic. This testimony is based on GAO's 2004 report on disease surveillance; reports and testimony on influenza outbreaks, influenza vaccine supply, and pandemic planning that GAO has issued since October 2000; and work GAO has done in May 2005 to update key information. Federal public health officials plan to rely on the nation's existing influenza surveillance system and enhancements to identify an influenza pandemic. CDC currently collaborates with multiple public health partners, including the World Health Organization (WHO), to obtain data that provide national and international pictures of influenza activity. Federal public health officials and health care organizations have undertaken several initiatives that are intended to enhance influenza surveillance capabilities. While some of these initiatives are focused more generally on increasing preparedness for bioterrorism and other emerging infectious disease health threats, others have been undertaken in preparation for an influenza pandemic. For example, in response to concerns over the past few years about the potential for avian influenza to become the next influenza pandemic, CDC implemented an initiative in cooperation with WHO to improve influenza surveillance in Asia. CDC has also implemented initiatives to improve the communications systems it uses to collect and disseminate surveillance information. In addition, CDC, the Department of Agriculture, and the Food and Drug Administration have made efforts to enhance their coordination of surveillance efforts for diseases that arise in animals and can be transferred to humans, such as SARS and certain strains of influenza with the potential to become pandemic. While public health officials have undertaken several initiatives to enhance influenza surveillance capabilities, challenges remain with regard to other aspects of preparedness for and response to an influenza pandemic. In particular, the Department of Health and Human Services (HHS) has not finalized planning for an influenza pandemic. In 2000, GAO recommended that HHS complete the national plan for responding to an influenza pandemic, but the plan has been in draft format since August 2004. Absent a completed federal plan, key questions about the federal role in the purchase, distribution, and administration of vaccines and antiviral drugs during a pandemic remain unanswered. Other challenges with regard to preparedness for and response to an influenza pandemic exist across the public and private sectors, including challenges in ensuring an adequate and timely influenza vaccine and antiviral supply; addressing regulatory, privacy, and procedural issues surrounding measures to control the spread of disease, for example, across national borders; and resolving issues related to an insufficient hospital and health workforce capacity for responding to a large-scale outbreak such as an influenza pandemic. Thu, 26 May 2005 00:00:00 -0400 http://www.gao.gov/new.items/d05210.pdf Diabetes, which afflicts millions of Americans, is a manageable disease whose effects can be mitigated with proper care, regularly received. Experts recommend certain services and supplies for managing diabetes. Because these can be costly, concerns exist about whether individuals with diabetes have access to and receive what they need. Little is known, however, about health plan coverage of diabetes services and supplies. GAO reviewed the extent to which (1) states require insurance policies to cover diabetes services and supplies, (2) health coverage not subject to state requirements includes diabetes services and supplies, and (3) individuals with diabetes ages 18 and older receive services and supplies. GAO analyzed all 50 states' and the District of Columbia's laws and regulations pertaining to diabetes coverage. GAO also obtained from selected health plans providing coverage not subject to state requirements--13 large-employer plans and 3 plans in the Federal Employees Health Benefits Program (FEHBP)--information on coverage of 10 services and nine supplies identified as important for individuals with diabetes. In addition, GAO obtained national data from the Centers for Disease Control and Prevention (CDC) on individuals' receipt of diabetes services and supplies. GAO received technical comments from CDC and incorporated them in the report as appropriate. In 2004, 47 states, including the District of Columbia, had laws or regulations related to coverage of diabetes services or supplies, although specific requirements varied by state. Services for which states most often required coverage were diabetes education (45 states) and medical nutrition therapy (27 states). All 47 required coverage of diabetes supplies, although some states were more specific than others about which supplies must be covered. Health plans GAO contacted that provide coverage not subject to state insurance requirements--those offered by 13 large Fortune 500 companies and the 3 largest health plans in FEHBP--covered most of the services and supplies recommended for individuals with diabetes, generally without limits on the coverage. Each plan covered at least 7 of 10 diabetes services, such as an annual blood glucose test, cholesterol and blood pressure monitoring, and influenza vaccinations, as well as at least five of nine diabetes supplies, such as insulin and insulin-administering supplies. According to a 2003 CDC nationwide survey, the majority of individuals with diabetes reported receiving at least one diabetes service within the past 12 months. Significantly fewer individuals, however, reported receiving five services that individuals with diabetes are recommended to receive at least once a year. For example, an estimated 88 percent reported receiving a test for blood glucose, whereas an estimated 33 percent had received the five recommended services: blood glucose and cholesterol tests, eye and foot exams, and an influenza vaccination. Receipt of diabetes services and supplies varied by service, state, and whether an individual had health coverage. For example, 71 percent of individuals with diabetes who had health coverage at the time of the survey received eye exams, compared with 46 percent of individuals with diabetes who lacked coverage. Fri, 25 Feb 2005 00:00:00 -0500 http://www.gao.gov/new.items/d05177t.pdf Influenza is associated with an average of 36,000 deaths and more than 200,000 hospitalizations each year in the United States. Persons who are aged 65 and older, people with chronic medical conditions, children younger than 2 years, and pregnant women are more likely to get severe complications from influenza than other people. The best way to prevent influenza is to be vaccinated each fall. In early October 2004, one major manufacturer of flu vaccine for the United States announced that its facility's license had been temporarily suspended and it would not be releasing any vaccine for the 2004-2005 flu season. Because this manufacturer was expected to produce roughly one-half of the U.S. flu vaccine supply, the shortage resulting from its announcement has led to concern about the availability of flu vaccine, especially to those at high risk for flu-related complications. GAO was asked to discuss issues related to the supply, demand, and distribution of vaccine for this flu season in the context of the current shortage. GAO based this testimony on products we have issued since May 2001, as well as work we conducted to update key information. The current vaccine shortage demonstrates the challenges to ensuring an adequate and timely flu vaccine supply. Only three manufacturers produce flu vaccine for the U.S. market, and the potential for future manufacturing problems such as those experienced both this year and to a lesser degree in previous years is still present. When shortages occur, their effect can be exacerbated by the existing distribution system. Under this system, health providers and vaccine distributors generally order a particular manufacturer's vaccine and have limited recourse, even for meeting the needs of high-risk persons, if that manufacturer's production is adversely affected. By contrast, providers who purchased vaccine from a different manufacturer might receive more of their order and be able to vaccinate their high-risk patients. The current situation also reflects another concern: the nation lacks a systematic approach for ensuring that seniors and others at high risk for flu-related complications receive flu vaccine when it is in short supply. Once this year's shortage became apparent, the Centers for Disease Control and Prevention (CDC) took a number of steps to influence distribution patterns to help providers get some vaccine for their high-risk patients. These steps are still playing themselves out, and it will take more time to assess how well they will work. Problems have not been totally averted, however, as there have been media reports of long lines to obtain limited doses of vaccine and of high-risk individuals unable to find a flu vaccination in a timely fashion. Thu, 18 Nov 2004 00:00:00 -0500 http://www.gao.gov/new.items/d04877.pdf The threat posed by infectious diseases has grown. New diseases, unknown in the United States just a decade ago, such as West Nile virus and severe acute respiratory syndrome (SARS), have emerged. To detect cases of infectious diseases, especially before they develop into widespread outbreaks, local, state, and federal public health officials as well as international organizations conduct disease surveillance. Disease surveillance is the process of reporting, collecting, analyzing, and exchanging information related to cases of infectious diseases. In this report GAO was asked to examine disease surveillance efforts in the United States. Specifically, GAO described (1) how state and federal public health officials conduct surveillance for infectious diseases and (2) initiatives intended to enhance disease surveillance. GAO reviewed documents, such as policy manuals and reports related to disease surveillance, and interviewed officials from selected federal departments and agencies, including the Departments of Defense (DOD), Agriculture (USDA), and Homeland Security (DHS) as well as the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). GAO conducted structured interviews of state public health officials from 11 states. Surveillance for infectious diseases in the United States comprises a variety of efforts at the state and federal levels. At the state level, state health departments collect and analyze data on cases of infectious diseases. These data are required to be reported by health care providers and others to the state. State public health departments verify reported cases of diseases, monitor disease incidence, identify possible outbreaks within their state, and report this information to CDC. At the federal level, agencies and departments collect and analyze disease surveillance data and maintain disease surveillance systems. For example, CDC uses the reports of diseases from the states to monitor national health trends, formulate and implement prevention strategies, and evaluate state and federal disease prevention efforts. FDA analyzes information on outbreaks of infectious diseases that originate from foods that the agency regulates. Some federal agencies and departments also fund and operate their own disease surveillance systems and laboratory networks and have several means of sharing surveillance information with local, state, and international public health partners. State and federal public health officials have implemented a number of initiatives intended to enhance disease surveillance, but challenges remain. For example, officials have implemented and expanded syndromic surveillance systems, which monitor the frequency and distribution of health-related symptoms among people within a specific geographic area. Although syndromic surveillance systems are used by federal agencies and departments and in all of the states whose officials GAO interviewed, concerns have been raised about this approach to surveillance. Specifically, syndromic surveillance systems are relatively costly to maintain compared to other types of surveillance and are still largely untested. Public health officials are also implementing initiatives designed to enhance public health communications and disease reporting. For example, CDC is working to increase the number of participants using its public health communication systems. In addition, state public health departments and CDC are implementing an initiative designed to make electronic disease reporting more timely, accurate, and complete. However, the implementation of this initiative is incomplete. Finally, federal public health officials have enhanced federal coordination on disease surveillance and expanded training programs for epidemiologists and other public health experts. In commenting on a draft of this report, the Department of Health and Human Services (HHS) said the report captures many important issues in surveillance. HHS also provided suggestions to clarify the discussion. Thu, 30 Sep 2004 00:00:00 -0400 http://www.gao.gov/new.items/d041100t.pdf Influenza is associated with an average of 36,000 deaths and more than 200,000 hospitalizations each year in the United States. Persons aged 65 and older are involved in more than 9 of 10 deaths and 1 of 2 hospitalizations related to influenza. The best way to prevent influenza is to be vaccinated each fall. In the 2000-01 flu season, and again in the 2003-04 flu season, this country experienced periods when the demand for flu vaccine exceeded the supply, and there is concern about the availability of vaccines for this and future flu seasons. There is also concern about the prospect of a worldwide influenza epidemic, or pandemic, which many experts believe to be inevitable. Three influenza pandemics occurred in the twentieth century. Experts estimate that the next pandemic could kill up to 207,000 people in the United States and cause major social disruption. Public health experts have raised concerns about the ability of the nation's public health system to respond to an influenza pandemic. GAO was asked to discuss issues related to supply, demand, and distribution of vaccine for a regular flu season and assess the federal plan to respond to an influenza pandemic. GAO based this testimony on products it has issued since October 2000, as well as work it conducted to update key information. Challenges persist in ensuring an adequate and timely flu vaccine supply. The number of producers remains limited, and the potential for manufacturing problems such as those experienced in recent years is still present. If a manufacturer's production is affected, those providers who ordered vaccine from that manufacturer could experience shortages, while providers who received supplies from another manufacturer might have all the vaccine they need. This potential for imbalance is what creates situations in which some providers might not have enough vaccine for persons at highest risk, while other providers might have enough supply to hold mass-immunization clinics even for persons at lower risk for flu-related complications. To help limit the potential for such situations, the Centers for Disease Control and Prevention (CDC) and others have taken such steps as adding flu vaccine to federal stockpiles and more aggressively monitoring the projected supply of vaccine. However, there is no system in place to ensure that seniors and others at high risk for complications receive flu vaccinations first when vaccine is in short supply. The Department of Health and Human Services' (HHS) draft "Pandemic Influenza Preparedness and Response Plan" provides a blueprint for the government's role but leaves some important decisions about the government's response unresolved. In addition to describing the federal role, responsibilities, and actions in collaboration with the states in responding to an influenza pandemic, the plan also provides planning guidance to state and local health departments and the health care system. The draft plan is comprehensive in scope, but it leaves decisions about the purchase, distribution, and administration of vaccines open for public comment and for the states to decide individually. In addition, the draft plan does not make recommendations for how population groups should be prioritized to receive vaccines in a pandemic. Difficulties encountered during the annual flu season in the purchase, distribution, and administration of flu vaccine highlight the importance of resolving these issues for pandemic preparedness. Officials from CDC provided technical comments on this testimony that GAO incorporated as appropriate. Tue, 28 Sep 2004 00:00:00 -0400 http://www.gao.gov/new.items/d04458t.pdf The anthrax incidents in the fall of 2001 and the severe acute respiratory syndrome (SARS) outbreak in 2002-2003 have raised concerns about the nation's ability to respond to a major public health threat, whether naturally occurring or the result of bioterrorism. The anthrax incidents strained the public health system, including laboratory and workforce capacities, at the state and local levels. The SARS outbreak highlighted the challenges of responding to new and emerging infectious disease. The current influenza season has heightened concerns about the nation's ability to handle a pandemic. GAO was asked to examine improvements in state and local preparedness for responding to major public health threats and federal and state efforts to prepare for an influenza pandemic. This testimony is based on GAO's recent report, HHS Bioterrorism Preparedness Programs: States Reported Progress but Fell Short of Program Goals for 2002, GAO-04- 360R (Feb. 10, 2004). This testimony also updates information contained in GAO's report on federal and state planning for an influenza pandemic, Influenza Pandemic: Plan Needed for Federal and State Response, GAO- 01-4 (Oct. 27, 2000). Although states have further developed many important aspects of public health preparedness, since April 2003, no state is fully prepared to respond to a major public health threat. States have improved their disease surveillance systems, laboratory capacity, communication capacity, and workforce needed to respond to public health threats, but gaps in each remain. Moreover, regional planning between states is lacking, and many states lack surge capacity--the capacity to evaluate, diagnose, and treat the large numbers of patients that would present during a public health emergency. Although states are developing plans for receiving and distributing medical supplies and material for mass vaccinations from the Strategic National Stockpile in the event of a public health emergency, most of these plans are not yet finalized. HHS has not published the federal influenza pandemic plan, and most of the state plans have not been finalized. In 2000, GAO recommended that HHS complete the national plan for responding to an influenza pandemic, but according to HHS, the plan is still under review. Absent a federal plan, key questions about the federal role in the purchase, distribution, and administration of vaccines and antiviral drugs during a pandemic remain unanswered. HHS reports that most states continue to develop their state plans despite the lack of a federal plan. Thu, 12 Feb 2004 00:00:00 -0500 http://www.gao.gov/new.items/d031058t.pdf SARS is a highly contagious respiratory disease that infected more than 8,000 individuals in 29 countries principally throughout Asia, Europe, and North America and led to more than 800 deaths as of July 11, 2003. Due to the speed and volume of international travel and trade, emerging infectious diseases such as SARS are difficult to contain within geographic borders, placing numerous countries and regions at risk with a single outbreak. While SARS did not infect large numbers of individuals in the United States, the possibility that it may reemerge raises concerns about the ability of public health officials and health care workers to prevent the spread of the disease in the United States. GAO was asked to assist the Subcommittee in identifying ways in which the United States can prepare for the possibility of another SARS outbreak. Specifically, GAO was asked to determine 1) infectious disease control measures practiced within health care and community settings that helped contain the spread of SARS and 2) the initiatives and challenges in preparing for a possible SARS resurgence. Infectious disease experts emphasized that no new infectious disease control measures were introduced to contain SARS in the United States. Instead, strict compliance with and additional vigilance to enforce the use of current measures was sufficient. These measures--case identification and contact tracing, transmission control, and exposure management--are well established infectious disease control measures that proved effective in both health care and community settings. The combinations of measures that were used depended on either the prevalence of the disease in the community or the number of SARS patients served in a health care facility. For SARS, case identification within health care settings included screening individuals for fever, cough, and recent travel to a country with active cases of SARS. Contact tracing, the identification and tracking of individuals who had close contact with someone who was infected or suspected of being infected, was important for the identification and tracking of individuals at risk for SARS. Transmission control measures for SARS included contact precautions, especially hand washing after contact with someone who was ill, and protection against respiratory spread, including spread by large droplets and by smaller airborne particles. The use of isolation rooms with controlled airflow and the use of respiratory masks by health care workers were key elements of this approach. Exposure management practices--isolation and quarantine--occurred in both health care and home settings. Effective communication among health care professionals and the general public reinforced the need to adhere to infectious disease control measures. While no one knows whether there will be a resurgence of SARS, federal, state, and local health care officials agree that it is necessary to prepare for the possibility. As part of these preparations, CDC, along with national associations representing state and local health officials, and others, is involved in developing both SARS-specific guidelines for using infectious disease control measures and contingency response plans. In addition, these associations have collaborated with CDC to develop a checklist of preparedness activities for state and local health officials. Such preparation efforts also improve the health care system's capacity to respond to other infectious disease outbreaks, including those precipitated by bioterrorism. However, implementing these plans during a large-scale outbreak may prove difficult due to limitations in both hospital and workforce capacity that could result in overcrowding, as well as potential shortages in health care workers and medical equipment--particularly respirators. Wed, 30 Jul 2003 00:00:00 -0400 http://www.gao.gov/new.items/d03769t.pdf SARS has infected relatively few people nationwide, but it has raised concerns about preparedness for large-scale infectious disease outbreaks. The initial response to an outbreak occurs in local agencies and hospitals, with support from state and federal agencies, and can involve disease surveillance, epidemiologic investigation, health care delivery, and quarantine management. Officials have learned lessons applicable to preparedness for such outbreaks from experiences with other major public health threats. GAO was asked to examine the preparedness of state and local public health agencies and hospitals for responding to a large-scale infectious disease outbreak and the relationship of federal and state planning for an influenza pandemic to preparedness for emerging infectious diseases. This testimony is based on Bioterrorism: Preparedness Varied across State and Local Jurisdictions, GAO-03-373 (Apr. 7, 2003); findings from a GAO survey on hospital emergency room capacity (in Hospital Emergency Departments: Crowded Conditions Vary among Hospitals and Communities, GAO-03-460 (Mar. 14, 2003)) and on hospital emergency preparedness; and information updating Influenza Pandemic: Plan Needed for Federal and State Response, GAO-01-4 (Oct. 27, 2000). The efforts of public health agencies and health care organizations to increase their preparedness for major public health threats such as bioterrorism and the worldwide influenza outbreaks known as pandemics have improved the nation's capacity to respond to SARS and other emerging infectious disease outbreaks, but gaps in preparedness remain. Specifically, GAO found that there are gaps in disease surveillance systems and laboratory facilities and that there are workforce shortages. The level of preparedness varied across seven cities GAO visited, with jurisdictions that have had multiple prior experiences with public health emergencies being generally more prepared than others. GAO found that planning for regional coordination was lacking between states. GAO also found that states were developing plans for receiving and distributing medical supplies for emergencies and for mass vaccinations in the event of a public health emergency. GAO found that most hospitals lack the capacity to respond to large-scale infectious disease outbreaks. Most emergency departments have experienced some degree of crowding and therefore in some cases may not be able to handle a large influx of patients during a potential SARS or other infectious disease outbreak. Most hospitals across the country reported participating in basic planning activities for such outbreaks. However, few hospitals have adequate medical equipment, such as the ventilators that are often needed for respiratory infections such as SARS, to handle the large increases in the number of patients that may result. The public health response to outbreaks of emerging infectious diseases such as SARS could be improved by the completion of federal and state influenza pandemic response plans that address problems related to the purchase, distribution, and administration of supplies of vaccines and antiviral drugs during an outbreak. The Centers for Disease Control and Prevention has provided interim draft guidance to facilitate state plans but has not made the final decisions on plan provisions necessary to mitigate the effects of potential shortages of vaccines and antiviral drugs in the event of an influenza pandemic. Wed, 07 May 2003 00:00:00 -0400 http://www.gao.gov/new.items/d03654t.pdf Following the bioterrorist events of the fall of 2001, there has been concern that the nation may not be prepared to respond to a major public health threat, such as the current outbreak of Severe Acute Respiratory Syndrome (SARS). Whether a disease outbreak occurs naturally or is due to the intentional release of a harmful biological agent by a terrorist, much of the initial response would occur at the local level, particularly hospitals and their emergency departments. Efforts to plan for worldwide influenza pandemics are useful for understanding public health preparedness for other large-scale outbreaks. GAO was asked to examine (1) the preparedness of state and local public health agencies and organizations for responding to a large-scale infectious disease outbreak, (2) the preparedness of hospitals for responding to a large-scale infectious disease outbreak, and (3) federal and state efforts to prepare for an influenza pandemic. This testimony is based on GAO's report, Bioterrorism: Preparedness Varied across State and Local Jurisdictions, GAO-03-373 (Apr. 7, 2003), a survey of hospitals GAO conducted to assess their level of emergency preparedness, and information updating GAO's prior report on federal and state planning for an influenza pandemic, Influenza Pandemic: Plan Needed for Federal and State Response, GAO-01-4 (Oct. 27, 2000). The efforts of state and local public health agencies to prepare for a bioterrorist attack have improved the nation's capacity to respond to infectious disease outbreaks and other major public health threats, but gaps in preparedness remain. GAO found workforce shortages and gaps in disease surveillance and laboratory facilities. The level of preparedness varied across cities GAO visited. Jurisdictions that have had multiple prior experiences with public health emergencies were generally more prepared than others. GAO found that regional planning was generally lacking between states but that states were developing their own plans for receiving and distributing medical supplies for emergencies, as well as plans for mass vaccinations in the event of a public health emergency. GAO found that many hospitals lack the capacity to respond to large-scale infectious disease outbreaks. Most hospitals across the country reported participating in basic planning activities for large-scale infectious disease outbreaks and training staff about biological agents. However, most hospitals lack adequate equipment, isolation facilities, and staff to treat a large increase in the number of patients that may result. Federal and state officials have not finalized plans for responding to pandemic influenza. These plans do not consistently address problems related to the purchase, distribution, and administration of supplies of vaccines and antiviral drugs that may be needed during a pandemic. Wed, 09 Apr 2003 00:00:00 -0400 http://www.gao.gov/new.items/d01786t.pdf Until the 2001 flu season, the production and distribution of influenza vaccine generally went smoothly. Last year, however, several people reported that they wanted but could not get flu shots. In addition, physicians and public health departments could not provide shots to high-risk patients in their medical offices and clinics because they had not received vaccine they ordered many months in advance, or because they were being asked to pay much higher prices for vaccine in order to get it right away. At the same time, there were reports that providers in other locations, even grocery stores and restaurants, were offering flu shots to everyone--including younger, healthier people who were not at high risk. This testimony discusses the delays in production, distribution, and pricing of the 2000-2001 flu vaccine. GAO found that manufacturing difficulties during the 2000-2001 flu season resulted in an overall delay of about six to eight weeks in shipping vaccine to most customers. This delay created an initial shortage and temporary price spikes. There is no system in place to ensure that high-risk people have priority for receiving flu shots when supply is short. Because vaccine purchases are mainly done in the private sector, federal actions to help mitigate any adverse effects of vaccine delays or shortages need to rely to a great extent on collaboration between the public and private sectors. Wed, 30 May 2001 00:00:00 -0400 http://www.gao.gov/new.items/d01624.pdf Until the 2000-2001 flu season, the production and the distribution of flu vaccine generally went smoothly. In the fall of 2000, however, stories began to circulate about delays in obtaining flu vaccines. GAO reviewed (1) the circumstances that contributed to the delay and the effects the delay had on prices paid for vaccine, (2) how effectively current distribution channels ensure that high-risk populations receive vaccine on a priority basis, and (3) what the federal government is doing to better prepare for possible disruptions of influenza vaccine supply. GAO found that manufacturing difficulties resulted in an overall delay of about 6-8 weeks in shipping vaccine to most customers and a temporary price spike. Manufacturers experienced unprecedented problems growing a new viral strain, while two of four manufacturers halted production--one permanently--to address safety and quality control concerns. There is currently no system to ensure that high-risk patients have priority when the supply of vaccine is short. Although the federal government has no direct control over how influenza vaccine is purchased and distributed by the private sector and state and local governments, the Department of Health and Human Services (HHS) has several efforts underway to help cope with future influenza vaccine shortages and delays. For example, the Centers for Disease Control and Prevention (CDC) revised guidelines to extend the recommended timeframe for receiving immunizations. CDC is also helping to bring together manufacturers, distributors, providers, and others in the private and public sectors to explore ways to improve distribution to high-risk individuals. Tue, 15 May 2001 00:00:00 -0400 http://www.gao.gov/new.items/d014.pdf Public health experts have raised concerns about the ability of the nation's public health system to detect and respond to emerging infectious disease threats, such as pandemic influenza. Although vaccines are considered the first line of defense to prevent or reduce influenza-related illness and death, GAO found that they may be unavailable, in short supply, or ineffective for some portions of the population during the first wave of a pandemic. Federal and state influenza pandemic plans are in various stages of completion and do not completely or consistently address key issues surrounding the purchase, distribution, and administration of vaccines and antiviral drugs. Inconsistencies in state and federal policies could contribute to public confusion and weaken the effectiveness of the public health response. Fri, 27 Oct 2000 00:00:00 -0400 http://archive.gao.gov/f1010/102846.pdf The swine flu program was the Government's first attempt at immunizing the entire U.S. population. The Department of Health, Education and Welfare (HEW) lost its gamble in this episode of preventive medicine, but much can be learned from the program that should be useful in planning future immunization programs and related public health efforts. Legal liability continues to be a problem in immunization programs. All vaccine released for use utimately met Food and Drug Administration potency and safety standards. Potential protection provided by the vaccine is difficult to estimate. Not enough vaccine was produced or produced on time to immunize everyone in the United States had there been a swine flu outbreak. State readiness and implementation was never fully tested. Costs may far exceed the $135 million appropriated. Mon, 27 Jun 1977 00:00:00 -0400