Influenza Pandemic: Gaps in Pandemic Planning and Preparedness Need to Be Addressed
Published: 2009-07-29T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: (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.

section_title: Letter
paragraphs: I am pleased to be here today to discuss key themes from the body of  work GAO has developed over the past several years to help the nation  better prepare for, respond to, and recover from a possible influenza  pandemic. An influenza pandemic remains a real threat to our nation and  to the world, as we are witnessing during the current H1N1 pandemic. The  previous administration took a number of actions to plan for a pandemic,  including developing a national strategy and implementation plan.  However, much more needs to be done, and many gaps in planning and  preparedness still remain. Strengthening preparedness for large-scale  public health emergencies, such as an influenza pandemic, is one of 13  urgent issues that we identified earlier this year as among those needing  the immediate attention of the new administration and Congress.
In the past 3 years, GAO has issued 12 reports and 4 testimonies on  influenza pandemic planning. We synthesized the results of most of our  work in a February 2009 report, which I will discuss in more detail today.  In addition, I will discuss key results from our recent report on protecting  the federal workforce in the event of a pandemic. We have made 24  recommendations based on the findings from these reports, 13 of which  have been acted upon by the responsible federal agencies. The responsible  federal agencies have generally agreed with our recommendations and  some actions are underway to address them. However, 11  recommendations have not yet been fully implemented. While our  February 2009 report made no new recommendations, it reflects the status  of those recommendations that were made prior to our June 2009 report  that had not yet been implemented. Many of the recommendations that  remain unimplemented have become even more pressing in light of the  very real possibility of the return of a more severe form of the H1N1 virus  later this year. Lists of our open recommendations and related GAO  products that are referenced throughout this statement are located in  attachments I and II.
In summary, my statement will address the following issues which were  drawn from the key themes of GAO’s pandemic work:    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.
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.
Pandemic planning and exercising have 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.
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.
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.
Performance monitoring and accountability for pandemic  preparedness needs strengthening. For example, the May 2006  National Strategy for Pandemic Influenza Implementation Plan  (National Pandemic 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  that provide the operational details of how agencies will protect their  employees and maintain essential operations and services.
As noted earlier, this statement is based on our prior work, which was  conducted in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: Given the consequences of a severe influenza pandemic, in 2006, GAO  developed a strategy for our work that would help support Congress’s  decision making and oversight related to pandemic planning. Our strategy  was built on a large body of work spanning two decades, including reviews  of government responses to prior disasters such as Hurricanes Andrew  and Katrina, the devastation caused by the 9/11 terror attacks, efforts to  address the Year 2000 (Y2K) computer challenges, and assessments of  public health capacities in the face of bioterrorism and emerging  infectious diseases such as Severe Acute Respiratory Syndrome (SARS).  The strategy was built around six key themes as shown in figure 1. While  all of these themes are interrelated, our earlier work underscored the  importance of leadership, authority, and coordination, a theme that  touches on all aspects of preparing for, responding to, and recovering from  an influenza pandemic.
Influenza pandemic—caused by a novel strain of influenza virus for which  there is little resistance and which therefore is highly transmissible among  humans—continues to be a real and significant threat facing the United  States and the world. Unlike incidents that are discretely bounded in space  or time (e.g., most natural or man-made disasters), an influenza pandemic  is not a singular event, but is likely to come in waves, each lasting weeks  or months, and pass through communities of all sizes across the nation  and the world simultaneously. However, the current H1N1 pandemic  seems to be relatively mild, although widespread. The history of an  influenza pandemic suggests it could return in a second wave this fall or  winter in a more virulent form. While a pandemic will not directly damage  physical infrastructure such as power lines or computer systems, it  threatens the operation of critical systems by potentially removing the  essential personnel needed to operate them from the workplace for weeks  or months. In a severe pandemic, absences attributable to illnesses, the  need to care for ill family members, and fear of infection may, according to  the Centers for Disease Control and Prevention (CDC), reach a projected  40 percent during the peak weeks of a community outbreak, with lower  rates of absence during the weeks before and after the peak. In addition,  an influenza pandemic could result in 200,000 to 2 million deaths in the  United States, depending on its severity.
The President’s Homeland Security Council (HSC) took an active  approach to this potential disaster by, among other things, issuing the  National Strategy for Pandemic Influenza (National Pandemic Strategy)  in November 2005, and the National Pandemic Implementation Plan in  May 2006. The National Pandemic Strategy is intended to provide a high- level overview of the approach that the federal government will take to  prepare for and respond to an influenza pandemic. It also provides  expectations for nonfederal entities—including state, local, and tribal  governments; the private sector; international partners; and individuals— to prepare themselves and their communities. The National Pandemic  Implementation Plan is intended to lay out broad implementation  requirements and responsibilities among the appropriate federal agencies  and clearly define expectations for nonfederal entities. The Plan contains  324 action items related to these requirements, responsibilities, and  expectations, most of which were to be completed before or by May 2009.  HSC publicly reported on the status of the action items that were to be  completed by 6 months, 1 year, and 2 years in December 2006, July 2007,  and October 2008 respectively. HSC indicated in its October 2008 progress  report that 75 percent of the action items have been completed. We have  ongoing work for this committee assessing the status of implementing this  plan which we expect to report on in the fall of 2009.
section_title: Leadership Roles and Responsibilities Need to Be Clarified and Tested, and Coordination Mechanisms Could Be Better Utilized
paragraphs: Federal government leadership roles and responsibilities for pandemic  preparedness and response are evolving, and will require further testing  before the relationships among the many federal leadership positions are  well understood. Such clarity in leadership is even more crucial now, given  the change in administration and the associated transition of senior  federal officials. Most of these federal leadership roles involve shared  responsibilities between the Department of Health and Human Services  (HHS) and the Department of Homeland Security (DHS), and it is not clear  how these would work in practice. According to the National Pandemic  Strategy and Plan, the Secretary of Health and Human Services is to lead  the federal medical response to a pandemic, and the Secretary of  Homeland Security will lead the overall domestic incident management  and federal coordination. In addition, under the Post-Katrina Emergency  Management Reform Act of 2006, the Administrator of the Federal  Emergency Management Agency (FEMA) was designated as the principal  domestic emergency management advisor to the President, the HSC, and  the Secretary of Homeland Security, adding further complexity to the  leadership structure in the case of a pandemic. To assist in planning and  coordinating efforts to respond to a pandemic, in December 2006 the  Secretary of Homeland Security predesignated a national Principal Federal  Official (PFO) for influenza pandemic and established five pandemic  regions each with a regional PFO and Federal Coordinating Officers (FCO)  for influenza pandemic. PFOs are responsible for facilitating federal  domestic incident planning and coordination, and FCOs are responsible  for coordinating federal resources support in a presidentially declared  major disaster or emergency.
However, the relationship of these roles to each other as well as with other  leadership roles in a pandemic is unclear. Moreover, as we testified in July  2007, state and local first responders were still uncertain about the need  for both FCOs and PFOs and how they would work together in disaster  response. Accordingly, we recommended in our August 2007 report on  federal leadership roles and the National Pandemic Strategy that DHS and  HHS develop rigorous testing, training, and exercises for influenza  pandemic to ensure that federal leadership roles and responsibilities for a  pandemic are clearly defined and understood and that leaders are able to  effectively execute shared responsibilities to address emerging  challenges. In response to our recommendation, HHS and DHS officials  stated in January 2009 that several influenza pandemic exercises had been  conducted since November 2007 that involved both agencies and other  federal officials, but it is unclear whether these exercises rigorously tested  federal leadership roles in a pandemic.
In addition to concerns about clarifying federal roles and responsibilities  for a pandemic and how shared leadership roles would work in practice,  private sector officials told us that they are unclear about the respective  roles and responsibilities of the federal and state governments during a  pandemic emergency. The National Pandemic Implementation Plan states  that in the event of an influenza pandemic, the distributed nature and  sheer burden of the disease across the nation would mean that the federal  government’s support to any particular community is likely to be limited,  with the primary response to a pandemic coming from states and local  communities. Further, federal and private sector representatives we  interviewed at the time of our October 2007 report identified several key  challenges they face in coordinating federal and private sector efforts to  protect the nation’s critical infrastructure in the event of an influenza  pandemic. One of these was a lack of clarity regarding the roles and  responsibilities of federal and state governments on issues such as state  border closures and influenza pandemic vaccine distribution.
Coordination Mechanisms  Mechanisms and networks for collaboration and coordination on  pandemic preparedness between federal and state governments and the  private sector exist, but they could be better utilized. In some instances,  the federal and private sectors are working together through a set of  coordinating councils, including sector-specific and cross-sector councils.  To help protect the nation’s critical infrastructure, DHS created these  coordinating councils as the primary means of coordinating government  and private sector efforts for industry sectors such as energy, food and  agriculture, telecommunications, transportation, and water. Our October  2007 report found that DHS has used these critical infrastructure  coordinating councils primarily to share pandemic information across  sectors and government levels rather than to address many of the  challenges identified by sector representatives, such as clarifying the roles  and responsibilities between federal and state governments. We  recommended in the October 2007 report that DHS encourage the councils  to consider and address the range of coordination challenges in a potential  influenza pandemic between the public and private sectors for critical  infrastructure. DHS concurred with our recommendation and DHS  officials informed us at the time of our February 2009 report that the  department was working on initiatives to address it, such as developing  pandemic contingency plan guidance tailored to each of the critical  infrastructure sectors, and holding a series of “webinars” with a number of  the sectors.
Federal executive boards (FEB) bring together federal agency and  community leaders in major metropolitan areas outside of Washington,  D.C., to discuss issues of common interest, including an influenza  pandemic. The Office of Personnel Management (OPM), which provides  direction to the FEBs, and the FEBs have designated emergency  preparedness, security, and safety as an FEB core function. The FEB’s  emergency support role with its regional focus may make the boards a  valuable asset in pandemic preparedness and response. 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. In a May 2007 report on the FEBs’  ability to contribute to emergency operations, we found that many of the  selected FEBs included in our review were building capacity for influenza  pandemic response within their member agencies and community  organizations by hosting influenza pandemic training and exercises. We  recommended that, since FEBs are well positioned within local  communities to bring together federal agency and community leaders, the  Director of OPM work with FEMA to formally define the FEBs’ role in  emergency planning and response. As a result of our recommendation,  FEBs were included in the National Response Framework (NRF) in  January 2008 as one of the regional support structures that have the  potential to contribute to development of situational awareness during an  emergency. OPM and FEMA also signed a memorandum of understanding  in August 2008 in which FEBs and FEMA agreed to work collaboratively in  carrying out their respective roles in the promotion of the national  emergency response system.
section_title: 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
paragraphs: International disease surveillance and detection efforts serve as an early  warning system that could prevent the spread of an influenza pandemic  outbreak. The United States and its international partners are involved in  efforts to improve pandemic surveillance, including diagnostic  capabilities, so that outbreaks can be quickly detected. Yet, as reported in  2007, international capacity for surveillance has many weaknesses,  particularly in developing countries. As a result, assessments of the risks  of the emergence of influenza pandemic by U.S. agencies and international  organizations, which were used to target assistance to countries at risk,  were based on insufficiently detailed or incomplete information, limiting  their value for comprehensive comparisons of risk levels by country.
section_title: Pandemic Planning and Exercising Has Occurred, but Planning Gaps Remain
paragraphs: The National Pandemic Strategy and National Pandemic Implementation  Plan are important first steps in guiding national preparedness. However,  important gaps exist that could hinder the ability of key stakeholders to  effectively execute their responsibilities. In our August 2007 report on the  National Pandemic Strategy and Implementation Plan, we found that while  these documents are an important first step in guiding national  preparedness, they do not fully address all six characteristics of an  effective national strategy, as identified in our work. The documents fully  address only one of the six characteristics, by reflecting a clear description  and understanding of problems to be addressed. Further, the National  Pandemic Strategy and Implementation Plan do not address one  characteristic at all, containing no discussion of what it will cost, where  resources will be targeted to achieve the maximum benefits, and how it  will balance benefits, risks, and costs. Moreover, the documents do not  provide a picture of priorities or how adjustments might be made in view  of resource constraints. Although the remaining four characteristics are  partially addressed, important gaps exist that could hinder the ability of  key stakeholders to effectively execute their responsibilities. For example,  state and local jurisdictions that will play crucial roles in preparing for and  responding to a pandemic were not directly involved in developing the  National Pandemic Implementation Plan, even though it relies on these  stakeholders’ efforts. Stakeholder involvement during the planning  process is important to ensure that the federal government’s and  nonfederal entities’ responsibilities are clearly understood and agreed  upon. Further, relationships and priorities among actions were not clearly  described, performance measures were not always linked to results, and  insufficient information was provided about how the documents are  integrated with other response-related plans, such as the NRF. We  recommended that the HSC establish a process for updating the National  Pandemic Implementation Plan and that the updated plan should address  these and other gaps. HSC did not comment on our recommendation and  has not indicated if it plans to implement it.
subsections: section_title: Federal Workforce Pandemic Planning
paragraphs: The National Pandemic Implementation Plan required federal agencies to  develop operational plans for protecting their employees and maintaining  essential operations and services in the event of a pandemic. In our June  2009 report, we found that federal agency progress in pandemic planning  is uneven. We surveyed the pandemic coordinators from the 24 agencies  covered by the Chief Financial Officers Act of 1990, which we  supplemented with a case study approach of 3 agencies. We used the  survey to get an overview of governmentwide pandemic influenza  preparedness efforts. The survey questions asked about pandemic plans;  essential functions other than first response that employees cannot  perform remotely; protective measures, such as procuring pharmaceutical  interventions; social distancing strategies; information technology  testing; and communication of human capital pandemic policies. Although  all of the surveyed agencies reported being engaged in planning for  pandemic influenza to some degree, several agencies reported that they  were still in the early stages of developing their pandemic plans and their  measures to protect their workforce. For example, several agencies  responded that they had yet to identify essential functions during a  pandemic that cannot be performed remotely. And, although many of the  agencies’ pandemic plans rely on telework to carry out their functions, 5  agencies reported testing their information technology capability to little  or no extent.
The 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. The  Department of 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. By contrast, the Federal  Aviation Administration’s 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.
section_title: State and Local Pandemic Planning
paragraphs: We reported in June 2008 that, according to CDC, all 50 states and the 3  localities that received federal pandemic funds have developed influenza  pandemic plans and conducted pandemic exercises in accordance with  federal funding guidance. A portion of the $5.62 billion that Congress  appropriated in supplemental funding to HHS for pandemic preparedness  in 2006—$600 million—was specifically provided for state and local  planning and exercising. All 10 localities that we reviewed in depth had  also developed plans and conducted exercises, and had incorporated  lessons learned from pandemic exercises into their planning. However,  an HHS-led interagency assessment of states’ plans found on average that  states had “many major gaps” in their influenza pandemic plans in 16 of 22  priority areas, such as school closure policies and community  containment, which are community-level interventions designed to reduce  the transmission of a pandemic virus. The remaining 6 priority areas were  rated as having “a few major gaps.” Subsequently, HHS led another  interagency assessment of state influenza pandemic plans and reported in  January 2009 that although they had made important progress, most states  still had major gaps in their pandemic plans.
As we had reported in June 2008, HHS, in coordination with DHS and  other federal agencies, had convened a series of regional workshops for  states in five influenza pandemic regions across the country. Because  these workshops could be a useful model for sharing information and  building relationships, we recommended that HHS and DHS, in  coordination with other federal agencies, convene additional meetings  with states to address the gaps in the states’ pandemic plans. As reported  in February 2009, HHS and DHS generally concurred with our  recommendation, but have not yet held these additional meetings. HHS  and DHS indicated at the time of our February 2009 report that while no  additional meetings had been planned, states will have to continuously  update their pandemic plans and submit them for review.
We have also reported on the need for more guidance from the federal  government to help states and localities in their planning. In June 2008, we  reported that although the federal government has provided a variety of  guidance, officials of the states and localities we reviewed told us that they  would welcome additional guidance from the federal government in a  number of areas, such as community containment, to help them to better  plan and exercise for an influenza pandemic. Other state and local  officials have identified similar concerns. According to the National  Governors Association’s (NGA) September 2008 issue brief on states’  pandemic preparedness, states are concerned about a wide range of  school-related issues, including when to close schools or dismiss students,  how to maintain curriculum continuity during closures, and how to  identify the appropriate time at which classes could resume. NGA also  reported that states generally have very little awareness of the status of  disease outbreaks, either in real time or in near real time, to allow them to  know precisely when to recommend a school closure or reopening in a  particular area. NGA reported that states wanted more guidance in the  following areas: (1) workforce policies for the health care, public safety,  and private sectors; (2) schools; (3) situational awareness such as  information on the arrival or departure of a disease in a particular state,  county, or community; (4) public involvement; and (5) public-private  sector engagement.
section_title: Private Sector Pandemic Planning
paragraphs: The private sector has also been planning for an influenza pandemic, but  many challenges remain. To better protect critical infrastructure, federal  agencies and the private sector have worked together across a number of  sectors to plan for a pandemic, including developing general pandemic  preparedness guidance, such as checklists for continuity of business  operations during a pandemic. However, federal and private sector  representatives have acknowledged that sustaining preparedness and  readiness efforts for an influenza pandemic is a major challenge, primarily  because of the uncertainty associated with a pandemic, limited financial  and human resources, and the need to balance pandemic preparedness  with other, more immediate, priorities, such as responding to outbreaks of  foodborne illnesses in the food sector and, now, the effects of the financial  crisis.
In our March 2007 report on preparedness for an influenza pandemic in  one of these critical infrastructure sectors—financial markets—we found  that despite significant progress in preparing markets to withstand  potential disease pandemics, securities and banking regulators could take  additional steps to improve the readiness of the securities markets. The  seven organizations that we reviewed—which included exchanges,  clearing organizations, and payment-system processors—were working on  planning and preparation efforts to reduce the likelihood that a worldwide  influenza pandemic would disrupt their critical operations. However, only  one of the seven had completed a formal plan. To increase the likelihood  that the securities markets will be able to function during a pandemic, we  recommended that the Chairman, Federal Reserve; the Comptroller of the  Currency; and the Chairman, Securities and Exchange Commission (SEC),  consider taking additional actions to ensure that market participants  adequately prepare for a pandemic outbreak. In response to our  recommendation, the Federal Reserve and the Office of the Comptroller of  the Currency, in conjunction with the Federal Financial Institutions  Examination Council and the SEC directed all banking organizations  under their supervision to ensure that the pandemic plans the financial  institutions have in place are adequate to maintain critical operations  during a severe outbreak. SEC issued similar requirements to the major  securities industry market organizations.
section_title: Further Actions Are Needed to Address the Capacity to Respond to and Recover from an Influenza Pandemic
paragraphs: Improving the nation’s response capability to catastrophic disasters, such  as an influenza pandemic, is essential. Following a mass casualty event,  health care systems would need the ability to adequately care for a large  number of patients or patients with unusual or highly specialized medical  needs. The ability of local or regional health care systems to deliver  services could be compromised, at least in the short term, because the  volume of patients would far exceed the available hospital beds, medical  personnel, pharmaceuticals, equipment, and supplies. Further, in natural  and man-made disasters, assistance from other states may be used to  increase capacity, but in a pandemic, states would likely be reluctant to  provide assistance to each other due to scarce resources and fears of  infection.
Over the last few years, Congress has provided over $13 billion in  supplemental funding for pandemic preparedness. The $5.62 billion that  Congress provided in supplemental funding to HHS in 2006 was for, among  other things, (1) monitoring disease spread to support rapid response, (2)  developing vaccines and vaccine production capacity, (3) stockpiling  antivirals and other countermeasures, (4) upgrading state and local  capacity, and (5) upgrading laboratories and research at CDC. The  majority of this supplemental funding—about 77 percent—was allocated  for developing antivirals and vaccines for a pandemic, and purchasing  medical supplies. Also, a portion of the funding that went to states and  localities for preparedness activities—$170 million—was allocated for  state antiviral purchases for their state stockpiles. In June 2009, Congress  approved and the President signed a supplemental appropriations act that  included $7.7 billion for pandemic flu preparedness, including the  development and purchase of vaccine, antivirals, necessary medical  supplies, diagnostics, and other surveillance tools and to assist  international efforts and respond to international needs relating to the  2009–H1N1 influenza outbreak. This amount included $1.85 billion to be  available immediately and $5.8 billion to be available subsequently in the  amounts designated by the President as emergency funding requirements.  On July 10, 2009, HHS announced its plans to use the $350 million  designated for upgrading state and local capacity for additional grants to  states and territories to prepare for the H1N1 pandemic and seasonal  influenza. State public health departments will receive $260 million, and  hospitals will receive $90 million of these grant funds.
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. In a severe pandemic, the demand  would exceed the available hospital bed capacity, which would be further  challenged by the existing shortages of health care providers and their  potential high rates of absenteeism. In addition, the availability of  antivirals and vaccines could be inadequate to meet demand due to limited  production, distribution, and administration capacity.
The federal government has provided some guidance in addition to  funding to help states plan for additional capacity. For example, the  federal government provided guidance for states to use when preparing  for medical surge and on prioritizing target groups for an influenza  pandemic vaccine. Some state officials reported, however, that they had  not begun work on altered standards of care guidelines, that is, for  providing care while allocating scarce equipment, supplies, and personnel  in a way that saves the largest number of lives in mass casualty event, or  had not completed drafting guidelines, because of the difficulty of  addressing the medical, ethical, and legal issues involved. We  recommended that HHS serve as a clearinghouse for sharing among the  states altered standards of care guidelines developed by individual states  or medical experts. HHS did not comment on the recommendation, and it  has not indicated if it plans to implement it. Further, in our June 2008  report on state and local planning and exercising efforts for an influenza  pandemic, we found that state and local officials reported that they  wanted federal influenza pandemic guidance on facilitating medical surge,  which was also one of the areas that the HHS-led assessment rated as  having “many major gaps” nationally among states’ influenza pandemic  plans.
section_title: Federal Agencies Have Provided Considerable Guidance and Pandemic-Related Information, but Could Augment Their Efforts
paragraphs: The National Pandemic Implementation Plan emphasizes that government  and public health officials must communicate clearly and continuously  with the public throughout a pandemic. Accordingly, HHS, DHS, and other  federal agencies have shared pandemic-related information in a number of  ways, such as through Web sites, guidance, and state summits and  meetings, and are using established networks, including coordinating  councils for critical infrastructure protection, to share information about  pandemic preparedness, response, and recovery. Federal agencies have  established an influenza pandemic Web site (www.pandemicflu.gov) and  disseminated pandemic preparedness checklists for workplaces,  individuals and families, schools, health care, community organizations,  and state and local governments.
However, state and local officials from all of the states and localities we  interviewed for our June 2008 report on state and local pandemic planning  and exercising, wanted additional influenza pandemic guidance from the  federal government on specific topics, on how to implement community  interventions such as closing schools, fatality management, and facilitating  medical surge. Although the federal government had issued some guidance  at the time of our review, it may not have reached state and local officials  or may not have addressed the particular concerns or circumstances of the  state and local officials we interviewed. More recently, CDC has issued  additional guidance on a number of topics related to responding to the  H1N1 outbreak. CDC issued interim guidance on school closures which  originally recommended that schools with confirmed H1N1 influenza  close. Once it became more clear that the disease severity of H1N1 was  similar to that of seasonal influenza and that the virus had already spread  within communities, CDC determined that school closure would be less  effective as a measure of control and issued updated guidance  recommending that schools not close for suspected or confirmed cases of  influenza. However, the change in guidance caused confusion,  underscoring the importance of clear and continuous communication with  the public throughout a pandemic. In addition, private sector officials have  told us that they would like clarification about the respective roles and  responsibilities of the federal and state governments during an influenza  pandemic emergency, such as in state border closures and influenza  pandemic vaccine distribution.
section_title: Performance Monitoring and Accountability for Pandemic Preparedness Needs Strengthening
paragraphs: While the National Pandemic Strategy and Implementation Plan identify  overarching goals and objectives for pandemic planning, the documents  are not altogether clear on the roles, responsibilities, and requirements to  carry out the plan. Some of the action items in the National Pandemic  Implementation Plan, particularly those that are to be completed by state,  local, and tribal governments or the private sector, do not identify an  entity responsible for carrying out the action. Most of the implementation  plan’s performance measures consist of actions to be completed, such as  disseminating guidance, but the measures are not always clearly linked  with intended results.
For example, one action item asked that all HHS-, Department of Defense-,  and Veterans Administration-funded hospitals and health facilities  develop, test, and be prepared to implement infection control campaigns  for pandemic influenza within 3 months. However, the associated  performance measure is not clearly linked to the intended result. This  performance measure states that infection control guidance should be  developed and disseminated on www.pandemicflu.gov and other  channels. This action would not directly result in developing, testing, and  preparing to implement infection control campaigns. This lack of clear  linkage makes it difficult to ascertain whether progress has in fact been  made toward achieving the national goals and objectives described in the  National Pandemic Strategy and Implementation Plan. Without a clear  linkage to anticipated results, these measures of activities do not give an  indication of whether the purpose of the activity is achieved. In addition,  as discussed earlier, the National Pandemic Implementation Plan does not  establish priorities among its 324 action items, which becomes especially  important as agencies and other parties strive to effectively manage scarce  resources and ensure that the most important steps are accomplished.  Moreover, the National Pandemic Strategy and its Implementation Plan do  not provide information on the financial resources needed to implement  them, which is one of six characteristics of an effective national strategy  that we have identified. As a result, the documents do not provide a  picture of priorities or how adjustments might be made in view of  resource constraints.
As discussed earlier, the National Pandemic Implementation Plan also  required federal agencies to develop operational pandemic plans to  describe, among other requirements, how each agency will protect its  workforce and maintain essential operations and services in the event of a  pandemic.  We recently reported, however, that there is no mechanism in  place to monitor and report on agencies’ progress in developing these  plans. Under the Implementation Plan, DHS was charged with this  responsibility, but instead the HSC simply requested that agencies certify  to the council that they were addressing in their plans the applicable  elements of a pandemic checklist. The certification process did not  provide for monitoring and reporting on agencies’ abilities to continue  operations in the event of a pandemic while protecting their employees.  Moreover, even as envisioned under the Implementation Plan, the report  was to be directed to the Executive Office of the President with no  provision for the report to be made available to Congress.
As noted earlier, given agencies’ uneven progress in developing their  pandemic plans, monitoring and reporting would enhance agencies’  accountability to protect their employees during a pandemic. We therefore  recommended that the HSC request that the Secretary of Homeland  Security monitor and report to the Executive Office of the President on  the readiness of agencies to continue their operations while protecting  their employees in the event of a pandemic. We also suggested that to help  support its oversight responsibilities, Congress may want to consider  requiring DHS to report to it on agencies’ progress in developing and  implementing their plans, including any key challenges and gaps in the  plans. The HSC noted that it will give serious consideration to the report  findings and recommendations, and DHS said the report findings and  recommendations will contribute to its efforts to ensure that government  entities are well prepared for what may come next.
section_title: Concluding Observations
paragraphs: The current H1N1 influenza pandemic should serve as a powerful  reminder that the threat of a more virulent pandemic, which seemed to  fade from public awareness in recent years, never really disappeared.  While federal agencies have taken action on many of our  recommendations, about half the recommendations that we have made  over the past 3 years are still not fully implemented. It is essential, given  the change in administration and the associated transition of senior  federal officials, that the shared leadership roles that have been  established between HHS and DHS, along with other responsible federal  officials, are tested in rigorous tests and exercises. Likewise, DHS should  continue to work with other federal agencies and private sector members  of the critical infrastructure coordinating councils to help address the  challenges of coordination and clarify roles and responsibilities of federal  and state governments. DHS and HHS should also, in coordination with  other federal agencies, continue to work with states and local  governments to help them address identified gaps in their pandemic  planning. Moreover, the 3-year period covered by the National Pandemic  Implementation Plan is now over and it will be important for HSC to  establish a process for updating the National Pandemic Implementation  Plan so that the updated plan can address the gaps we have identified, as  well as lessons learned from the current H1N1 outbreak. Finally, greater  monitoring and reporting of agencies’ progress in plans to protect their  workers during a pandemic are needed to insure the readiness of agencies  to continue operations while protecting their employees in the event of a  pandemic.
Pandemic influenzas, as I noted earlier, differ from other types of disasters  in that they are not necessarily discrete events. While the current H1N1  pandemic seems to be relatively mild, the virus could become more  virulent this fall or winter. Given this risk, the administration and federal  agencies should use this opportunity to turn their attention to filling in  some of the planning and preparedness gaps our work has pointed out,  while time is still on our side.
Chairman Thompson and Members of the Committee, this concludes my  prepared statement. I would be happy to respond to any questions you  may have.
section_title: Contacts and Staff Acknowledgements
paragraphs: For further information regarding this statement, please contact Bernice  Steinhardt, Director, Strategic Issues, at (202) 512-6543 or  steinhardtb@gao.gov. Contact points for our Offices of Congressional  Relations and Public Affairs may be found on the last page of this  statement. Individuals making key contributions to this testimony include  Sarah Veale, (Assistant Director), Maya Chakko, David Fox, Bill Doherty,  Ellen Grady, Karin Fangman, and members of GAO’s Pandemic Working  Group.
section_title: Attachment I: Open Recommendations from GAO’s Work on an Influenza Pandemic
subsections: section_title: 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
paragraphs: The Homeland Security Council should  request that the Secretary of Homeland  Security monitor and report to the  Executive Office of the President on the  readiness of agencies to continue their  operations while protecting their employees  in the event of an influenza pandemic.
The Homeland Security Council  commented that the council will give  serious consideration to the report’s  findings and recommendations. DHS  commented that the report’s findings and  recommendations will contribute to its  efforts to ensure that government entities  are well prepared for what may come next.
The Secretary of Health and Human  Services should expeditiously finalize  guidance to assist state and local  jurisdictions to determine how to effectively  use limited supplies of antivirals and pre- pandemic vaccine in a pandemic, including  prioritizing target groups for pre-pandemic  vaccine.
In December 2008, HHS released final  guidance on antiviral drug use during an  influenza pandemic. HHS officials informed  us that they are drafting the guidance on  pre-pandemic influenza vaccination.
The Secretaries of Health and Human  Services and Homeland Security should, in  coordination with other federal agencies,  convene additional meetings of the states  in the five federal influenza pandemic  regions to help them address identified  gaps in their planning.
HHS and DHS officials indicated that while  no additional meetings are planned at this  time, states will have to continuously  update their pandemic plans and submit  them for review.
The Secretary of Homeland Security should  work with sector-specific agencies and lead  efforts to encourage the government and  private sector members of the councils to  consider and help address the challenges  that will require coordination between the  federal and private sectors involved with  critical infrastructure and within the various  sectors, in advance of, as well as during, a  pandemic.
DHS officials informed us that the  department is working on initiatives, such  as developing pandemic contingency plan  guidance tailored to each of the critical  infrastructure sectors, and holding a series  of webinars with a number of the sectors.
Influenza Pandemic: Further Efforts Are  Needed to Ensure Clearer Federal  Leadership Roles and an Effective National  Strategy, GAO-07-781, August 14, 2007 (1) The Secretaries of Homeland Security  and Health and Human Services should  work together to develop and conduct  rigorous testing, training, and exercises for  an influenza pandemic to ensure that the  federal leadership roles are clearly defined  and understood and that leaders are able  to effectively execute shared  responsibilities to address emerging  challenges. Once the leadership roles have  been clarified through testing, training, and  exercising, the Secretaries of Homeland  Security and Health and Human Services  should ensure that these roles are clearly  understood by state, local, and tribal  governments; the private and nonprofit  sectors; and the international community. (1) HHS and DHS officials stated that  several influenza pandemic exercises had  been conducted since November 2007 that  involved both agencies and other federal  officials, but it is unclear whether these  exercises rigorously tested federal  leadership roles in a pandemic.
Influenza Pandemic: Opportunities Exist to  Clarify Federal Leadership Roles and  Improve Pandemic Planning,  GAO-07-1257T, September 26, 2007  (2) The Homeland Security Council should  establish a specific process and time frame  for updating the National Pandemic  Implementation Plan. The process should  involve key nonfederal stakeholders and  incorporate lessons learned from exercises  and other sources. The National Pandemic  Implementation Plan should also be  improved by including the following  information in the next update: (a)  resources and investments needed to  complete the action items and where they  should be targeted, (b) a process and  schedule for monitoring and publicly  reporting on progress made on completing  the action items, (c) clearer linkages with  other strategies and plans, and (d) clearer  descriptions of relationships or priorities  among action items and greater use of  outcome-focused performance measures. (2) HSC did not comment on the  recommendation and has not indicated if it  plans to implement it.
Avian Influenza: USDA Has Taken  Important Steps to Prepare for Outbreaks,  but Better Planning Could Improve  Response, GAO-07-652, June 11, 2007  (1) The Secretaries of Agriculture and  Homeland Security should develop a  memorandum of understanding that  describes how USDA and DHS will work  together in the event of a declared  presidential emergency or major disaster,  or an Incident of National Significance, and  test the effectiveness of this coordination  during exercises. (1) Both USDA and DHS officials told us  that they have taken preliminary steps to  develop additional clarity and better define  their coordination roles. For example, the  two agencies meet on a regular basis to  discuss such coordination. (2) The Secretary of Agriculture should, in  consultation with other federal agencies,  states, and the poultry industry identify the  capabilities necessary to respond to a  probable scenario or scenarios for an  outbreak of highly pathogenic avian  influenza. The Secretary of Agriculture  should also use this information to develop  a response plan that identifies the critical  tasks for responding to the selected  outbreak scenario and, for each task,  identifies the responsible entities, the  location of resources needed, time frames,  and completion status. Finally, the  Secretary of Agriculture should test these  capabilities in ongoing exercises to identify  gaps and ways to overcome those gaps. (2) USDA officials told us that it has created  a draft preparedness and response plan  that identifies federal, state, and local  actions, timelines, and responsibilities for  responding to highly pathogenic avian  influenza, but the plan has not been issued  yet. (3) The Secretary of Agriculture should  develop standard criteria for the  components of state response plans for  highly pathogenic avian influenza, enabling  states to develop more complete plans and  enabling USDA officials to more effectively  review them. (3) USDA told us that it has drafted large  volumes of guidance documents that are  available on a secure Web site. However,  the guidance is still under review and it is  not clear what standard criteria from these  documents USDA officials and states  should apply when developing and  reviewing plans. (4) The Secretary of Agriculture should  focus additional work with states on how to  overcome potential problems associated  with unresolved issues, such as the  difficulty in locating backyard birds and  disposing of carcasses and materials. (4) USDA officials have told us that the  agency has developed online tools to help  states make effective decisions about  carcass disposal. In addition, USDA has  created a secure Internet site that contains  draft guidance for disease response,  including highly pathogenic avian influenza,  and it includes a discussion about many of  the unresolved issues. (5) The Secretary of Agriculture should  determine the amount of antiviral  medication USDA would need in order to  protect animal health responders, given  various highly pathogenic avian influenza  scenarios. The Secretary of Agriculture  should also determine how to obtain and  provide supplies within 24 hours of an  outbreak. (5) USDA officials told us that the National  Veterinary Stockpile contains enough  antiviral medication to protect 3,000 animal  health responders for 40 days. However,  USDA has yet to determine the number of  individuals who would need medicine  based on a calculation of those exposed to  the virus under a specific scenario. Further,  USDA officials told us that a contract for  additional medication for the stockpile has  not yet been secured, which would better  ensure that medications are available in the  event of an outbreak of highly pathogenic  avian influenza.
section_title: Attachment II: Related GAO Products
paragraphs: Influenza Pandemic: Greater Agency Accountability Needed to Protect  Federal Workers in the Event of a Pandemic. GAO-09-783T. Washington,  D.C.: June 16, 2009.
Influenza Pandemic: Increased Agency Accountability Could Help  Protect Federal Employees Serving the Public in the Event of a  Pandemic. GAO-09-404. Washington, D.C.: June 12, 2009.
Influenza Pandemic: Continued Focus on the Nation’s Planning and  Preparedness Efforts Remains Essential. GAO-09-760T. Washington, D.C.:  June 3, 2009.
Influenza Pandemic: Sustaining Focus on the Nation’s Planning and  Preparedness Efforts. GAO-09-334. Washington, D.C.: February 26, 2009.
Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize  Guidance for Pharmaceutical Interventions. GAO-08-671. Washington,  D.C.: September 30, 2008.
Influenza Pandemic: Federal Agencies Should Continue to Assist States  to Address Gaps in Pandemic Planning. GAO-08-539. Washington, D.C.:  June 19, 2008.
Emergency Preparedness: States Are Planning for Medical Surge, but  Could Benefit from Shared Guidance for Allocating Scarce Medical  Resources. GAO-08-668. Washington, D.C.: June 13, 2008.
Influenza Pandemic: Efforts Under Way to Address Constraints on  Using Antivirals and Vaccines to Forestall a Pandemic. GAO-08-92.  Washington, D.C.: December 21, 2007.
Influenza Pandemic: Opportunities Exist to Address Critical  Infrastructure Protection Challenges That Require Federal and Private  Sector Coordination. GAO-08-36. Washington, D.C.: October 31, 2007.
Influenza Pandemic: Federal Executive Boards’ Ability to Contribute to  Pandemic Preparedness. GAO-07-1259T. Washington, D.C.: September 28,  2007.
Influenza Pandemic: Opportunities Exist to Clarify Federal Leadership  Roles and Improve Pandemic Planning. GAO-07-1257T. Washington, D.C.:  September 26, 2007.
Influenza Pandemic: Further Efforts Are Needed to Ensure   Clearer Federal Leadership Roles and an Effective National Strategy.  GAO-07-781. Washington, D.C.: August 14, 2007.
Emergency Management Assistance Compact: Enhancing EMAC’s  Collaborative and Administrative Capacity Should Improve National  Disaster Response. GAO-07-854. Washington, D.C.: June 29, 2007.
Influenza Pandemic: DOD Combatant Commands’ Preparedness Efforts  Could Benefit from More Clearly Defined Roles, Resources, and Risk  Mitigation. GAO-07-696. Washington, D.C.: June 20, 2007.
Influenza Pandemic: Efforts to Forestall Onset Are Under Way;  Identifying Countries at Greatest Risk Entails Challenges. GAO-07-604.  Washington, D.C.: June 20, 2007.
Avian Influenza: USDA Has Taken Important Steps to Prepare for  Outbreaks, but Better Planning Could Improve Response. GAO-07-652.  Washington, D.C.: June 11, 2007.
The Federal Workforce: Additional Steps Needed to Take Advantage of  Federal Executive Boards’ Ability to Contribute to Emergency  Operations. GAO-07-515. Washington, D.C.: May 4, 2007.
Financial Market Preparedness: Significant Progress Has Been Made,  but Pandemic Planning and Other Challenges Remain. GAO-07-399.  Washington, D.C.: March 29, 2007.
Influenza Pandemic: DOD Has Taken Important Actions to Prepare, but  Accountability, Funding, and Communications Need to be Clearer and  Focused Departmentwide. GAO-06-1042. Washington, D.C.: September 21,  2006.
Catastrophic Disasters: Enhanced Leadership, Capabilities, and  Accountability Controls Will Improve the Effectiveness of the Nation’s  Preparedness, Response, and Recovery System. GAO-06-618. Washington,  D.C.: September 6, 2006.
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