Influenza Pandemic
Sustaining Focus on the Nation's Planning and Preparedness Efforts Gao ID: GAO-09-334 February 26, 2009GAO 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.
GAO-09-334, Influenza Pandemic: Sustaining Focus on the Nation's Planning and Preparedness Efforts
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Report to the Chairman, Committee on Homeland Security, House of
Representatives:
United States Government Accountability Office:
GAO:
February 2009:
Influenza Pandemic:
Sustaining Focus on the Nation's Planning and Preparedness Efforts:
Pandemic Planning and Preparedness Efforts:
GAO-09-334:
GAO Highlights:
Highlights of GAO-09-334, a report to the Chairman, Committee on
Homeland Security, House of Representatives.
Why GAO Did This Study:
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.
What GAO Found:
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 pandemic-
related 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.
What GAO Recommends:
This report does not make new recommendations. However, the report
discusses the status of GAO‘s prior recommendations on the nation‘s
planning and preparedness for a pandemic.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-09-334]. For more
information, contact Bernice Steinhardt at (202) 512-6543 or
steinhardtb@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Leadership Roles and Responsibilities Need to Be Clarified and Tested,
and Coordination Mechanisms Could Be Better Utilized:
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:
Pandemic Planning and Exercising Has Occurred in the United States and
Other Countries, but Planning Gaps Remain:
Further Actions Are Needed to Address the Capacity to Respond to and
Recover from an Influenza Pandemic:
Federal Agencies Have Provided Considerable Guidance and Pandemic-
Related Information, but Could Augment Their Efforts:
Performance Monitoring and Accountability for Pandemic Preparedness
Needs Strengthening:
Concluding Observations:
Appendix I: Open Recommendations from GAO's Work on an Influenza
Pandemic as of February 2009:
Appendix II: Implemented Recommendations from GAO's Work on an
Influenza Pandemic as of February 2009:
Appendix III: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Figures:
Figure 1: Key Themes of GAO's Pandemic Strategy:
Figure 2: WHO Global Pandemic Phases:
Figure 3: Top 15 Recipients of Committed, Country-Specific
International Avian and Influenza Pandemic Funding as of December 2006:
Figure 4: HHS Influenza Pandemic Supplemental Appropriations, Fiscal
Year 2006:
Abbreviations:
APHIS: Animal and Plant Health Inspection Service:
CBO: Congressional Budget Office:
CDC: Centers for Disease Control and Prevention:
DHS: Department of Homeland Security:
DOD: Department of Defense:
EMAC: Emergency Management Assistance Compact:
FAO: Food and Agriculture Organization:
FCO: Federal Coordinating Officer:
FEB: federal executive board:
FEMA: Federal Emergency Management Agency:
HHS: Department of Health and Human Services:
HSC: Homeland Security Council:
NGA: National Governors Association:
National Pandemic Implementation Plan: National Strategy for Pandemic
Influenza Implementation Plan:
National Pandemic Strategy: National Strategy for Pandemic Influenza:
NRF: National Response Framework:
OIE: World Organisation for Animal Health:
OPM: Office of Personnel Management:
PFO: Principal Federal Official:
SEC: Securities and Exchange Commission:
UNSIC: United Nations System Influenza Coordinator:
USAID: United States Agency for International Development:
USDA: United States Department of Agriculture:
WHO: World Health Organization:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
February 26, 2009:
The Honorable Bennie G. Thompson:
Chairman:
Committee on Homeland Security:
House of Representatives:
Dear Mr. Chairman:
As you know, we 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. Our 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. At the same time, however, national
priorities are shifting as a pandemic has yet to occur, and the
nation's financial crisis and other national issues have become more
immediate and pressing. Nevertheless, an influenza pandemic remains a
real threat to our nation and to the world. Strengthening preparedness
for large-scale public health emergencies, such as an influenza
pandemic, is one of the 13 urgent issues that we identified as among
those needing the immediate attention of the new administration and
Congress during this transition period.[Footnote 1] As your Committee
also recently reported, there are opportunities to renew federal
efforts to protect our country against influenza pandemic in the new
administration.[Footnote 2]
Given the consequences of a severe influenza pandemic, in 2006 we
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.
Figure 1: Key Themes of GAO's Pandemic Strategy:
This figure is an illustration of the key themes of GAO's Pandemic
Strategy as puzzle pieces. The themes are as follows:
[Refer to PDF for image]
Performance and accountability;
Leadership, authority, and coordination;
Detecting threats and managing risks;
Information sharing and communication;
Capacity to respond and recover;
Planning, training, and exercising.
Source: GAO.
[End of figure]
At your request, this report synthesizes the work thus far completed
under this strategy. In the past 3 years, we have issued 11 reports and
two testimonies on influenza pandemic planning, which address these key
themes. We have made 23 recommendations based on the findings from many
of these reports and testimonies. Thirteen of these recommendations
have been acted upon by the responsible federal agencies, but while the
responsible federal agencies have generally agreed with our
recommendations, 10 recommendations have not yet been implemented. We
also have three pandemic-related reviews underway on the following
topics: (1) the status of implementing the National Strategy for
Pandemic Influenza Implementation Plan (National Pandemic
Implementation Plan); (2) plans to protect the federal workforce in a
pandemic; and (3) the effect of a pandemic on the telecommunications
capacity needed to sustain critical financial market activities. A list
of our open and implemented recommendations can be found in appendices
I and II. While this report makes no new recommendations, we have
updated the status of recommendations that have not yet been
implemented. A list of our related GAO products that are referenced
throughout this report is located after appendix III.
We also collaborated with several state and local audit offices on
coordinated audits of state and local pandemic planning and consulted
with audit offices from a number of countries on pandemic-related
activities through our external partnerships. These countries include
Austria, Belgium, Cambodia, Canada, Germany, Indonesia, Japan,
Kazakhstan, Sweden, the United Kingdom, and Vietnam. We have also drawn
from audits of pandemic planning and exercising conducted by audit
officials in Portland, Oregon; Kansas City, Missouri; and New York
state. Finally, we have incorporated recent studies conducted by the
Congressional Budget Office (CBO), National Governors Association
(NGA), United Nations System Influenza Coordinator (UNSIC), and the
World Bank.
This report is largely 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.
Results in Brief:
We have synthesized the results from our pandemic work over the past
few years by the six key themes in our pandemic strategy, as follows:
Leadership roles and responsibilities need to be clarified and tested,
and coordination mechanisms could be better utilized. 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. 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. For example, a system of
coordinating councils that facilitates planning between government and
the private sector for critical infrastructure protection could be
better used to help resolve key challenges to public and private sector
coordination. In addition, some federal executive boards (FEB), which
bring together federal agencies and community leaders outside of
Washington, D.C., have established relationships with state and local
governments and community organizations that could be useful in
pandemic preparedness and response. As a result of our recommendations,
FEBs were included in the National Response Framework (NRF)[Footnote 3]
in January 2008 as one of the regional support structures that have the
potential to contribute to the development of situational awareness
during an emergency.
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. 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, international capacity for surveillance has
many weaknesses, particularly in developing countries. Animal
surveillance is also a key part of this early warning system.
Controlling an outbreak in poultry would be instrumental to reducing
the risk of a human pandemic. While the U.S. Department of Agriculture
(USDA) has created a National Avian Influenza Surveillance System to
link existing avian influenza surveillance data from USDA, other
federal and state agencies, and industry, federal and state officials
generally do not know the numbers and locations of backyard birds so
controlling an outbreak of avian influenza among these birds remains
particularly difficult. Finally, at the time of our 2007 review,
assessments by U.S. agencies and international organizations were used
to target assistance to countries at risk, but the information on which
those assessments were based was not sufficiently detailed or was
incomplete, limiting their value for comprehensive comparisons of risk
levels by country.
Pandemic planning and exercising has occurred in the United States and
other countries, but planning gaps remain. The U.S. government has
worked with its international partners to develop an overall global
strategy that is compatible with the U.S. approach. Other countries,
including Belgium, Japan, Sweden, and the United Kingdom, have also
developed influenza pandemic plans and frameworks. While the National
Strategy for Pandemic Influenza (National Pandemic Strategy) and
National Pandemic Implementation Plan are important first steps in
guiding national preparedness, 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. Further, USDA response plans did not identify entities
responsible for carrying out tasks associated with an outbreak
scenario. At the state level, we found that each state has developed a
pandemic plan and conducted pandemic exercises as required by federal
pandemic funding guidance. However, according to an interagency
assessment, on average, states had "many major gaps" in their plans,
and the Department of Health and Human Services (HHS) has recently
reported that most states continue to have major gaps in their pandemic
plans. Officials in states and localities reported that they would
welcome additional guidance from the federal government to help them
better plan and exercise for an influenza pandemic, for example, on how
to implement community interventions such as closing schools. In the
private sector, in response to our recommendation, financial market
organizations were directed by their federal regulators to ensure that
the pandemic plans they have in place are adequate to maintain critical
operations during a severe outbreak.
Further actions are needed to address the capacity to respond to and
recover from an influenza pandemic. 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. The federal government has provided some guidance and
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. However, 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.[Footnote 4] 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.
Federal agencies have provided considerable guidance and pandemic-
related information, but could augment their efforts. Federal agencies,
including HHS and the Department of Homeland Security (DHS), 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 the FEBs and coordinating
councils for critical infrastructure protection, to share information
about pandemic preparedness, response, and recovery. Federal agencies
have established an influenza pandemic Web site [hyperlink,
http://www.pandemicflu.gov] and disseminated pandemic preparedness
checklists for workplaces, individuals and families, schools, health
care, community organizations, and state and local governments.
However, private sector and state and local government officials
continue to look for additional guidance and clarification from the
federal government for specific topics, such as state border closures
and fatality management.
Performance monitoring and accountability for pandemic preparedness
needs strengthening. 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. Moreover, the National Pandemic Strategy and
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.[Footnote 5]
As a result, the documents do not provide a picture of priorities or
how adjustments might be made in view of resource constraints. In the
case of the Department of Defense (DOD), although it had instituted
reporting requirements for its components responsible for implementing
action items tasked to DOD in the National Pandemic Implementation
Plan, there were not similar oversight mechanisms in place for other
pandemic-related tasks. For example, DOD did not require its components
to report on their development or revision of their continuity of
operations plans in preparation for an influenza pandemic.
Strengthening preparedness for large-scale public health emergencies,
including the possibility of an influenza pandemic, is one of the
urgent issues that we identified as among those needing the immediate
attention of the new administration and Congress during this transition
period. Although much has been done, many challenges remain, with
almost half the recommendations that we have made over the past 3 years
still not fully implemented. It will be essential for the
administration to test the shared leadership roles that have been
established between HHS and DHS, as these roles and responsibilities
continue to evolve, as well as the relative roles, responsibilities and
authorities for an influenza pandemic among the federal government,
state and local governments, and the private sector. DHS and HHS
should, in coordination with other federal agencies, continue to work
with states and local governments to help them address identified gaps
in their pandemic planning, as well as with the private sector through
the critical infrastructure coordinating councils. Despite other more
immediate national priorities, the threat of a severe influenza
pandemic remains, and the administration should maintain momentum in
preparing the nation.
Background:
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. While some scientists
and public health experts believe that the next influenza pandemic
could be caused by a highly pathogenic strain of the H5N1 avian
influenza virus (also known as "bird flu")[Footnote 6] that is
currently circulating in parts of Asia, Europe, and Africa, it is
unknown when an influenza pandemic will occur, where it will begin, or
whether an H5N1 virus or another strain would be the cause. Influenza
pandemic poses a grave threat to global 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.
Influenza pandemics have spread worldwide within months, and a future
pandemic is expected to spread even more quickly given modern travel
patterns.
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. 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.[Footnote 7] In addition, an influenza pandemic could result
in 200,000 to 2 million deaths in the United States, depending on its
severity.
In addition to the profound human costs in terms of illnesses and
deaths, the economic and societal repercussions of a pandemic could be
significant. In its December 2005 report on possible macroeconomic
effects and policy issues related to a potential influenza pandemic,
CBO stated that a severe influenza pandemic, similar to the 1918-1919
pandemic, might cause a decline in U.S. gross domestic product of about
4.25 percent.[Footnote 8] CBO updated its report in July 2006 to
include some estimates from medical experts that suggest that CBO may
have initially underestimated the economic impact.[Footnote 9] The
report also noted that these medical experts stressed the uncertainty
about the exact characteristics of the potential virus and suggested
that the worst-case scenario could be much worse than the severe
scenario that CBO considered, especially if the H5N1 virus acquires the
ability to spread efficiently among humans without losing its extreme
virulence. In addition, in September 2008, the World Bank reported that
a severe pandemic could cause a 4.8 percent drop in world economic
activity, which would cost the world economy more than $3
trillion.[Footnote 10]
WHO has developed six phases of pandemic alert, each divided into three
periods, as a system of informing the world of the seriousness of the
pandemic threat. As seen in figure 2, according to WHO the world is
currently in Phase 3 where a new influenza virus subtype is causing
disease in humans, but is not yet spreading efficiently and sustainably
among humans.
Figure 2: WHO Global Pandemic Phases:
[Refer to PDF for image]
Inter-pandemic phase: New virus in animals, no human cases: Low risk of
human cases: 1;
Inter-pandemic phase: New virus in animals, no human cases: Higher risk
of human cases: 2.
Pandemic alert: New virus causes no human cases: No or very limited
human-to-human transmission: 3(circled);
Pandemic alert: New virus causes no human cases: Evidence of increased
human-to-human transmission: 4;
Pandemic alert: New virus causes no human cases: Evidence of increased
human-to-human transmission: 5.
Pandemic: Efficient and sustained human-to-human transmission: 6.
Source: WHO.
Note: Circle indicates WHO assessment of current global phase.
[End of figure]
The Homeland Security Council (HSC) took an active approach to this
potential disaster by, among other things, issuing the 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 National Pandemic
Implementation Plan contains 324 action items related to these
requirements, responsibilities, and expectations, most of which are 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. As previously mentioned, we have
ongoing work assessing the status of implementing this plan.
Leadership Roles and Responsibilities Need to Be Clarified and Tested,
and Coordination Mechanisms Could Be Better Utilized:
Our prior work evaluating catastrophic event preparedness, response,
and recovery has shown that in the event of a catastrophic disaster,
the leadership roles, responsibilities, and lines of authority for the
response at all levels must be clearly defined and effectively
communicated to facilitate rapid and effective decision making,
especially in preparing for and in the early hours and days after the
event.[Footnote 11] 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.[Footnote 12] 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 HHS and 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.[Footnote 13] 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.[Footnote 14] 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.[Footnote 15] 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.
With respect to control of an outbreak in poultry, which would be
instrumental to reducing the risk of a human pandemic, both USDA and
DHS may become involved, depending on the level of the outbreak. USDA
is responsible for acting to prevent, control, and eradicate foreign
animal diseases in domestic livestock and poultry, in coordination with
a number of other entities, including states. The Secretary of Homeland
Security assumes responsibility for coordinating the federal response
under certain circumstances, such as an outbreak serious enough for the
President to declare an emergency or a major disaster. In a June 2007
report on USDA's planning for avian influenza, we found that USDA was
not planning for DHS to assume the lead coordinating role if an
outbreak among poultry occurred that is sufficient in scope to warrant
these declarations. To address challenges that limit the national
ability to quickly and effectively respond to highly pathogenic avian
influenza, we recommended that the Secretaries of Agriculture and
Homeland Security clarify their respective roles and how they will work
together in the event of a declared presidential emergency or major
disaster, and test the effectiveness of this coordination during
exercises.[Footnote 16] Both USDA and DHS agreed that they should
develop additional clarity and better define their coordination roles
in these circumstances, and have taken preliminary steps to do so. For
example, according to USDA and DHS officials, the two agencies meet on
a regular basis to discuss such coordination issues.
Roles and responsibilities for influenza pandemic preparedness can also
be unclear within individual federal agencies. In two reports on DOD
and its combatant commands' pandemic preparedness efforts, we noted
that while DOD and the combatant commands had taken numerous actions to
prepare for a pandemic, roles and responsibilities for pandemic
preparedness within the department and the commands had not been
clearly defined or communicated.[Footnote 17] Our September 2006 report
on DOD's pandemic preparedness noted that neither the Secretary nor the
Deputy Secretary of Defense had clearly and fully defined and
communicated lead and supporting roles and responsibilities with clear
lines of authority for DOD's influenza pandemic planning, and we
recommended that DOD do so. In response, DOD communicated
departmentwide that the Deputy Secretary of Defense had designated the
Assistant Secretary of Defense for Homeland Defense and Americas'
Security Affairs, working with the Assistant Secretary of Defense for
Health Affairs, to lead DOD's pandemic efforts. Similarly, in a June
2007 report, we recommended that DOD take steps to clarify U.S.
Northern Command's roles and responsibilities for pandemic planning and
preparedness efforts.[Footnote 18] In response, DOD clarified U.S.
Northern Command's roles and responsibilities in guidance and plans.
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 have 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.[Footnote 19] 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.[Footnote 20] 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.[Footnote 21] 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 in February 2009 that the department is 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.[Footnote 22]
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.[Footnote 23] 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.
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:
International disease surveillance and detection efforts serve to
address the threat posed by infectious diseases, such as an influenza
pandemic, before they develop into widespread outbreaks. Such efforts
also provide national and international public health authorities with
information for planning and managing efforts to control diseases such
as an influenza pandemic. However, as we have reported in the past,
domestic and international disease surveillance efforts need
improvement.[Footnote 24] For example, some state public health
departments' initiatives to enhance disease reporting have been
incomplete, and there is a need for national standards and
interoperability in information collection and sharing to detect
outbreaks. Globally, in December 2007 we reported that the United
States and its international partners are involved in efforts to
improve global influenza surveillance, including diagnostic
capabilities, so that pandemic strains can be quickly
detected.[Footnote 25] Yet, international capacity for influenza
surveillance still has many weaknesses, particularly in developing
countries. For example, some countries experiencing H5N1 human
influenza outbreaks, like Indonesia, had at times not promptly shared
human virus samples with the international community, thus further
weakening international surveillance efforts.
Efforts are also being made both within the United States and
internationally to improve surveillance and detection for highly
pathogenic avian influenza. As stated earlier, controlling an outbreak
in poultry would be instrumental to reducing the risk of a human
pandemic. Within the United States, USDA is taking many important
measures to help the nation prepare for outbreaks of highly pathogenic
avian influenza. In a June 2007 report on avian influenza, we stated
that USDA had developed several surveillance programs to detect highly
pathogenic avian influenza, including a long-standing voluntary program
that systematically tests samples of birds from participating poultry
operators' flocks for the virus.[Footnote 26] Further, we also stated
that USDA's Animal and Plant Health Inspection Service (APHIS) is
working with the Department of the Interior, state wildlife agencies,
and others to increase surveillance of wild birds in Alaska and the 48
contiguous states in addition to working with states and industry to
conduct surveillance of birds at auctions, swap meets, flea markets,
and public exhibitions. APHIS has also formed the National Avian
Influenza Surveillance System, designed to link existing avian
influenza surveillance data from USDA, other federal and state
agencies, and industry.
However, in the United States, federal and state officials generally do
not know the numbers and locations of backyard birds so controlling an
outbreak of highly pathogenic avian influenza among these birds remains
particularly difficult. We recommended that the Secretary of
Agriculture work with states to determine how to overcome potential
problems associated with unresolved issues, such as the difficulty in
locating backyard birds and disposing of carcasses and materials. USDA
agreed with our recommendation and efforts are underway. For example,
according to USDA officials, 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.
International surveillance networks for influenza in birds and other
animals have also been established and efforts are under way to improve
data sharing among scientists.[Footnote 27] However, global
surveillance of the disease among domestic animals has serious
shortfalls. The World Organisation for Animal Health (OIE) and the Food
and Agriculture Organization (FAO) collaborate to obtain and confirm
information on suspected highly pathogenic H5N1 cases. According to the
October 2008 report by the UNSIC and the World Bank on the state of
pandemic readiness,[Footnote 28] data obtained from national
authorities indicate that 75 percent of countries[Footnote 29] report
having a surveillance system that is operational and capable of
detecting highly pathogenic avian influenza. In addition, estimates of
risk for disease transmission from one country to another, as well as
among regions within countries, are difficult to make because of
uncertainties about how factors such as trade in poultry and other
birds and wild bird migration affect the movement of the disease.
Risk-Based Targeting of Assistance to Priority Countries:
Assessments by U.S. agencies and international organizations identified
widespread risks of the emergence of influenza pandemic, and the United
States identified priority countries for assistance. Our June 2007
report on international efforts to assess and respond to an influenza
pandemic risk noted that the bulk of U.S. and other donors' country-
specific commitments had been made to countries that the United States
had designated as priorities, with funding concentrated among certain
of these countries. We reported that through 2006, the United States
had committed about $377 million to improve global preparedness for
avian and influenza pandemic, 27 percent of the $1.4 billion committed
by all donors, which is the greatest share of funds of all donors.
Since we issued our June 2007 report, the UNSIC and the World Bank
reported that as of April 2008, the United States had committed $629
million, which is approximately 31 percent of the $2.05 billion
committed by all donors, for avian and pandemic influenza efforts.
Figure 3 shows the distribution of committed global and U.S. funding
across major recipient countries as of December 2006. Of the top 15
recipients of committed international funds, 11 were U.S. priority
countries. More recent data on U.S. funding patterns show similar
focuses on certain countries, with Indonesia the largest recipient,
followed by Vietnam and Cambodia.
Figure 3: Top 15 Recipients of Committed, Country-Specific
International Avian and Influenza Pandemic Funding as of December 2006:
[Refer to PDF for image]
U.S. Priority Countries: Vietnam;
U.S. total: 13.37;
All other donors: 74.44.
U.S. Priority Countries: Indonesia;
U.S. total: 24.65;
All other donors: 42.38.
U.S. Priority Countries: Nigeria;
U.S. total: 2.36;
All other donors: 56.51.
U.S. Priority Countries: Turkey;
U.S. total: 1.41;
All other donors: 44.99.
U.S. Priority Countries: Romania;
U.S. total: 3.06;
All other donors: 38.52.
U.S. Priority Countries: Cambodia;
U.S. total: 9.56;
All other donors: 17.8.
U.S. Priority Countries: Laos;
U.S. total: 7.69;
All other donors: 19.6.
U.S. Priority Countries: China;
U.S. total: 8.14;
All other donors: 3.07.
U.S. Priority Countries: Georgia;
U.S. total: 1.19;
All other donors: 10.
U.S. Priority Countries: Thailand;
U.S. total: 8.68;
All other donors: 0.1.
U.S. Priority Countries: Mexico;
U.S. total: 6.45;
All other donors: 0.
U.S. Priority Countries: Azerbaijan;
U.S. total: 0.75;
All other donors: 5.69.
Non-U.S. Priority Countries: Armenia;
U.S. total: 2.94;
All other donors: 7.59.
Non-U.S. Priority Countries: Moldova;
U.S. total: 0.86;
All other donors: 9.04.
Non-U.S. Priority Countries: West Bank Gaza;
U.S. total: 0.5;
All other donors: 13.
Source: GAO analysis of data compiled by the World Bank.
Notes: More recent data reported by the UNSIC and the World Bank on the
distribution of U.S. commitments, as of April 30, 2008, show a similar
focus on certain countries, with Indonesia the largest recipient of
U.S. country-specific commitments (about $48 million), followed by
Vietnam (about $21 million), and Cambodia (about $14 million).
The World Bank defines a commitment as the result of an agreement
between the donor and recipient for designated purposes or a firm
decision, such as a legislative appropriation, that prevents the use of
an allocated amount for other purposes.
Totals include funds from donor countries, international organizations,
and the World Bank administered Avian and Human Influenza Facility.
[End of figure]
However, we reported that gaps in available information from other
countries limited the capacity for comprehensive, well-informed
comparisons of risk levels by country.[Footnote 30] For example, in
2007 we reported that the United States Agency for International
Development's (USAID) environmental risk assessment of areas at
greatest risk for avian influenza outbreaks included a limited
understanding of the role of poultry trade or wild birds. USAID, the
Department of State, and the United Nations had also gathered
information that was not sufficiently detailed or complete enough to
permit well-informed country comparisons. Despite these limitations,
the HSC has used available information to designate priority countries
for assistance. The UNSIC and the World Bank stated in the 2008 report
that reports from national authorities responding to a UNSIC survey
indicate that 68 percent of countries[Footnote 31] had conducted a risk
assessment. As we previously reported in June 2007, adopting a risk
management approach can help manage the uncertainties in an influenza
pandemic and identify the most appropriate course of action.[Footnote
32] However, the FAO's detailed evaluation concluded that very few
countries have a surveillance plan that is based on an "elaborated"
risk-analysis.
Pandemic Planning and Exercising Has Occurred in the United States and
Other Countries, but Planning Gaps Remain:
By their very nature, catastrophic events involve extraordinary levels
of mass casualties, damage, or disruption that can overwhelm state and
local responders--making sound planning for catastrophic events
crucial. Strong advance planning, both within and among federal, state,
and local governments and other organizations, as well as robust
training and exercise programs to test these plans in advance of a real
disaster, are essential to best position the nation to prepare for,
respond to, and recover from major catastrophes such as an influenza
pandemic. Capabilities are built upon the appropriate combination of
people, skills, processes, and assets. Ensuring that needed
capabilities are available requires effective planning and coordination
as well as training and exercises in which the capabilities are
realistically tested, problems identified and lessons learned, and
subsequently addressed in partnership with other federal, state, and
local stakeholders. We have also noted that an incomplete understanding
of roles and responsibilities under the National Response Plan has
often led to misunderstandings, problems, and delays--an area where
training could be helpful. Key officials must actively and personally
participate so that they are better prepared to deal with real life
situations. In addition, as we previously reported on the federal
response to Hurricane Katrina, lessons learned from exercises must be
incorporated and used to improve emergency plans.[Footnote 33]
Pandemic Planning and Exercising in Other Countries:
A number of countries in addition to the United States have developed
pandemic plans, along with state and local governments, and the private
sector. We reported in June 2007 that the U.S. government has worked
with its international partners to develop an overall global strategy
that is compatible with the U.S. approach. These steps included the
appointment of a UNSIC and periodic global conferences to review
progress and refine the strategy.
Other countries, including Belgium, Japan, Sweden, and the United
Kingdom, have developed influenza pandemic plans and frameworks. In
July 2006, Belgium issued the Belgian pandemic flu preparedness plan
which provides basic information on various topics such as leadership,
antivirals, vaccines, surveillance, logistics, and public
communication.[Footnote 34] Similar to Belgium's pandemic plan, Japan
used WHO's six influenza pandemic phases in drafting government
policies and response efforts in its Pandemic Influenza Preparedness
Action Plan of the Japanese Government issued in November
2005.[Footnote 35] Sweden's National Audit Office reported in its
February 2008 audit that Sweden's Preparedness planning for pandemic
influenza - National Actions is focused only on infection control
services and the health sector and does not cover the rest of
society.[Footnote 36] To address this, the government of Sweden agreed
to further develop its plan by March 2010. Further, the Sweden's
National Audit Office found that there is very limited knowledge of the
extent to which municipalities can provide essential services in the
event of an influenza pandemic. Within the United Kingdom, the
government issued The National Framework for Responding to an Influenza
Pandemic and the Scottish National Framework for Responding to an
Influenza Pandemic in November 2007 and March 2007, respectively. Both
frameworks provide information and guidance to assist and support
public and private organizations across all sectors in understanding
the nature of the challenges and in making the appropriate preparations
for an influenza pandemic.[Footnote 37]
According to a UNSIC global survey, 141 countries, or 97 percent of
those that responded, have pandemic preparedness plans.[Footnote 38]
However, further analysis conducted by the UNSIC's Pandemic Influenza
Contingency Team and other institutions suggested that the quality and
comprehensiveness of these plans continue to vary significantly between
countries. UNSIC and the World Bank also found that there had been a
moderate increase in the number of countries that have undertaken
simulation exercises.[Footnote 39] Specifically, where testing has
occurred, 25 percent of respondents (37 of 145 countries), reported
that testing took place at both the national and local levels. In
addition, 37 percent of respondents (45 of 120 countries) have
incorporated the lessons learned from simulations into plan revisions.
Federal, State, and Local Government Pandemic Planning and Exercising:
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.[Footnote 40] 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.
Concerning federal government planning for an outbreak in animals, we
reported in 2007 that although USDA had also taken important steps to
prepare for outbreaks of highly pathogenic avian influenza, there were
still gaps in its planning. We noted that USDA was drafting response
plans for highly pathogenic avian influenza and was also working with
the HSC and other key federal agencies to produce an "interagency
playbook" intended to clarify how primary federal responders would
initially interact to respond to six scenarios of detection of highly
pathogenic H5N1. USDA had also begun preliminary exercises to test
aspects of these plans with federal, state, local, and industry
partners. However, USDA response plans did not identify the
capabilities needed to carry out the tasks associated with an outbreak
scenario--that is, the entities responsible for carrying them out, the
resources needed, and the source of those resources. To address these
gaps, we recommended that the Secretary of Agriculture identify these
capabilities, 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, and
test these capabilities in ongoing exercises to identify gaps and ways
to overcome those gaps. USDA concurred, and 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.
At the state and local levels, 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. All of
the 10 localities that we reviewed had also developed plans and
conducted exercises. Further, all of the 10 localities and the five
states that we reviewed had incorporated lessons learned from pandemic
exercises into their planning.[Footnote 41] 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." Since we issued our report in
June 2008, HHS led another interagency assessment of state influenza
pandemic plans. HHS reported in January 2009 that, based on this
assessment, although states have made important progress toward
preparing for combating an influenza pandemic, most states still have
major gaps in their pandemic plans.[Footnote 42] 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. HHS and DHS generally
concurred with our recommendation, but have not yet held these
additional meetings. HHS and DHS recently 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.
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. State and
local officials have identified similar concerns. An October 2007
Kansas City Auditor's Office report on influenza pandemic preparedness
in the city noted that Kansas City Health Department officials would
like the federal government to provide additional guidance on some of
the same issues we found, including clarifying community interventions
such as school closings.[Footnote 43] In addition, 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.[Footnote 44] In addition, NGA 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.
Private Sector Pandemic Planning:
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.[Footnote 45] Although 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, 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.
Further Actions Are Needed to Address the Capacity to Respond to and
Recover from an Influenza Pandemic:
Improving the nation's response capability to catastrophic disasters,
such as an influenza pandemic, is essential. Following a mass casualty
event of injured or ill victims, 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 consistent with
established standards of care[Footnote 46] 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. Providing such care would require the
allocation of scarce resources.
Medical Surge Capacity:
In contrast to discrete events such as hurricanes and most terrorist
attacks, the widespread and iterative nature of a pandemic--likely to
occur in waves as it spreads simultaneously through different
communities and regions--presents continuing challenges in preparing
for a medical surge in a mass casualty event such as a pandemic. Under
such conditions, emergency management approaches that have been used in
the past to increase capacity when responding to other types of
disasters, such as assistance from other states or the deployment of
military resources, may not be viable options since these groups may
need to hold onto resources in order to meet their own needs should
they be affected by the disease. We reported in June 2007 that state
officials informed us that the Emergency Management Assistance Compact
(EMAC), a collaborative arrangement among member states that provides a
legal framework for requesting resources and that has been used in
emergencies such as Hurricane Katrina, would not work in an influenza
pandemic.[Footnote 47] State officials reported their reluctance to
send personnel into an infected area, expressed their concern that
resources would not be available, and believed that personnel would be
reluctant to volunteer to go to another state. Further, NGA reported in
its September 2008 issue brief on state pandemic preparedness that EMAC
is seen as unreliable during a pandemic because states would likely be
unwilling to share scarce resources or deploy personnel into a location
where the disease is active and thus expose those individuals to a high-
risk environment.
HHS estimates that in a severe influenza pandemic, almost 10 million
people would require hospitalization, which would exceed the current
capacity of U.S. hospitals and necessitate difficult choices regarding
rationing of resources. HHS also estimates that almost 1.5 million of
these people would require care in an intensive care unit and about
740,000 people would require mechanical ventilation. In our September
2008 report on HHS's influenza pandemic planning efforts, we reported
that although HHS has initiated efforts to improve the surge capacity
of health care providers, these efforts will be challenged during a
severe pandemic because of the widespread nature of such an event, the
existing shortages of health care providers, and the potential high
absentee rate of providers. Given the uncertain effectiveness of
efforts to increase surge capacity, HHS has developed guidance to
assist health care facilities in planning for altered standards of
care; 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 events.[Footnote 48] As we reported in June 2008, 7
out of 20 states reviewed had adopted or were drafting altered
standards of care for specific medical issues. Three of the 7 states
had adopted some altered standards of care guidelines.[Footnote 49] We
also found that 18 of the 20 states reviewed were selecting alternate
care sites, which deliver medical care outside of a hospital setting
for patients who would normally be treated as inpatients.
In addition, we reported that the federal government has provided
funding, guidance, and other assistance to help states prepare for
medical surge in a mass casualty event, such as an influenza pandemic.
Further, the federal government has provided guidance for states to use
when preparing for medical surge, including Reopening Shuttered
Hospitals to Expand Surge Capacity, which contains a checklist that
states can use to identify entities that could provide more resources
in preparing for a medical surge and also provided other assistance
such as conferences and electronic bulletin boards for states to use in
preparing for medical surge. Some state officials reported, however,
that they had not begun work on altered standards of care guidelines,
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.[Footnote 50]
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.[Footnote 51]
Antivirals and Vaccine Capacity:
In fiscal year 2006, Congress appropriated $5.62 billion in
supplemental funding to HHS 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. Figure 4 shows that 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 for state and local
preparedness--$170 million--was allocated for state antiviral purchases
for their state stockpiles.
Figure 4: HHS Influenza Pandemic Supplemental Appropriations, Fiscal
Year 2006:
[Refer to PDF for image]
Pie graph:
Vaccine: $3,233: 58%;
Antivirals[C]: $911: 16%;
State and local preparedness[C]: $770: 14%;
Other domestic [B]: $276: 5%;
International activities: $179: 3%;
Medical supplies (personal protective equipment, ventilators, etc.):
$170: 3%;
Risk communications: $51: 1%.
Source: GAO, HHS.
Notes: Data are from the Department of Health and Human Services,
Pandemic Planning Update III: A Report from Secretary Michael O.
Leavitt (Washington, D.C.: Nov. 13, 2006).
[A] International activities includes: international preparedness,
surveillance, response, and research.
[B] Other domestic includes: surveillance, quarantine, lab capacity,
rapid tests.
[C] State and local preparedness includes funding for state subsidies
of antiviral drugs.
[D] This chart does not include $30 million in supplemental funding
that was transferred to the U.S. Agency for International Development.
[End of figure]
According to HHS's Pandemic Influenza Implementation Plan, HHS seeks to
ensure the availability of antiviral treatment courses for at least 25
percent of the U.S. population or at least 81 million treatment
courses.[Footnote 52] As of May 2008, both HHS and states had
stockpiled a total of 72 million treatment courses. Specifically, HHS
had stockpiled 44 million courses of antivirals for treatment in the
HHS-managed Strategic National Stockpile, which is a national
repository of medical supplies that is designed to supplement
stockpiles from state and local jurisdictions in the event of a public
health emergency, and had reserved an additional 6 million courses from
its federally stockpiled antivirals for containment of an initial
outbreak. HHS also subsidized the purchase of 31 million treatment
courses by state and local jurisdictions for storage in their own
stockpiles, of which 22 million treatment courses had been stockpiled.
In our December 2007 report on using antivirals and vaccines to
forestall a pandemic, we found that the availability of antivirals and
vaccines in a pandemic could be inadequate to meet demand due to
limited production, distribution, and administration capacity.[Footnote
53] As we reported, WHO estimated that the quantity of antivirals
required to forestall a pandemic would be enough treatment courses for
25 percent of the population. In addition, there would need to be
enough preventative courses to last 20 days for the remaining 75
percent of the population in the outbreak contamination zone. Further,
due to the time required to detect the virus and develop and
manufacture a targeted vaccine for a pandemic, pandemic vaccines are
likely to play little or no role in efforts to stop or contain a
pandemic at least in its initial phases. According to a September 2008
CBO report on the United States' policy regarding pandemic vaccines, if
an influenza pandemic were to occur today, it would be impossible to
vaccinate the entire population of about 300 million people within the
following 6 months because current capacity for domestic production
would be completely inadequate.[Footnote 54]
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, but some
of these efforts face limitations. We reported in September 2008 that
HHS was making large investments in domestic vaccine manufacturing
capacity by supporting vaccine research with contracts that require
manufacturers to establish vaccine-producing facilities within U.S.
borders.[Footnote 55] Through these contracts, one U.S. facility has
expanded its manufacturing capacity and a second facility was recently
established in the United States. Further, according to a January 2009
report by HHS, the department awarded $120 million to vaccine
manufacturers to retrofit their existing U.S. vaccine manufacturing
facilities for egg-based vaccines[Footnote 56] while also planning to
build domestic cell-based vaccine[Footnote 57] production facilities
within the U.S. by awarding approximately $500 million in contracts in
fiscal year 2009.[Footnote 58]
CBO also reported that HHS is not only encouraging the expansion and
refurbishing of existing facilities but also funding the development of
new adjuvants, substances that can be added to influenza vaccines to
reduce the amount of active ingredient (also called antigen) needed per
dose of vaccine. By using adjuvants for egg-based and cell-based
vaccines, domestic manufacturers could produce more doses in existing
facilities, which means that fewer new facilities would be needed to
manufacture cell-based formulations and smaller stockpiles could be
used to protect a larger population.[Footnote 59]
However, increasing production capacity of vaccines and antivirals will
take several years, as new facilities are built and necessary materials
acquired. Also, weaknesses within the international influenza
surveillance system impede the detection of strains, which could limit
the ability to promptly administer or develop effective antivirals and
vaccines to treat and prevent cases of infection to prevent its spread.
The delayed use of antivirals and the emergence of antiviral resistance
in influenza strains could limit their effectiveness. In addition,
limited support for clinical trials could hinder their ability to
improve understanding of the use of antivirals and vaccines against a
pandemic strain.
In light of this anticipated limitation in supply, HHS released
guidance on prioritizing target groups for a pandemic vaccine. Because
of the uncertainties surrounding the availability of a pandemic
vaccine, in September 2008, we recommended that the Secretary of Health
and Human Services expeditiously finalize guidance to assist state and
local jurisdictions to determine how to effectively use limited
supplies of antivirals, and the pre-pandemic vaccine, which is
developed prior to an outbreak using strains that have the potential to
cause an influenza pandemic.[Footnote 60] In December 2008, HHS
released final guidance on antiviral drug use during an influenza
pandemic.[Footnote 61] In addition, HHS officials informed us in
February 2009 that it is drafting guidance on pre-pandemic influenza
vaccination.
In addition to antiviral and vaccine stockpiles for an influenza
pandemic for the general population, our June 2007 report on avian
influenza planning concluded that USDA had significant gaps in its
planning for providing antivirals to individuals responsible for
responding to an outbreak of highly pathogenic avian
influenza.[Footnote 62] USDA has coordinated with DHS and other federal
agencies to create a National Veterinary Stockpile. This stockpile is
intended to be the nation's repository of animal vaccines, personal
protective equipment, and other critical veterinary products to respond
to the most dangerous foreign animal diseases, including highly
pathogenic avian influenza. However, at the time of the report, USDA
had not yet estimated the amount of antiviral medication that it would
need in the event of a highly pathogenic avian outbreak or resolved how
to provide such supplies within the first 24 hours of an outbreak.
According to Occupational Safety and Health Administration guidelines,
poultry workers responding to an outbreak of highly pathogenic avian
influenza should take antiviral medication daily. Further, the National
Veterinary Stockpile is required to contain sufficient amounts of
antiviral medication to respond to the most damaging animal diseases
that affect human health and the economy and has not yet obtained any
antiviral medication for highly pathogenic avian influenza. However,
HHS officials told National Veterinary Stockpile officials that the
antiviral medication in the Strategic National Stockpile was reserved
only for use during a human pandemic. We therefore recommended that the
Secretary of Agriculture determine the amount of antiviral medication
that USDA would need in order to protect animal health responders,
given various highly pathogenic avian influenza scenarios, and
determine how to obtain and provide supplies within 24 hours of an
outbreak. In commenting on our recommendation, USDA officials told us
that the National Veterinary Stockpile now contains enough antiviral
medication to protect 3,000 animal health responders for 40 days.
However, USDA officials told us that they have yet to determine the
number of individuals that would need medicine based on a calculation
of those exposed to the virus under a specific scenario. Further, USDA
officials said 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.
Federal Agencies Have Provided Considerable Guidance and Pandemic-
Related Information, but Could Augment Their Efforts:
Our work evaluating public health and natural disaster catastrophe
preparedness, response, and recovery has shown that insufficient
collaboration among federal, state, and local governments created
challenges for sharing public health information and developing
interoperable communications for first responders. In 2005, we
designated establishing appropriate and effective information-sharing
mechanisms to improve homeland security as a high-risk area. Over the
past several years, we have identified potential information-sharing
barriers, critical success factors, and other key management issues
that should be considered to facilitate information sharing among and
between government entities and the private sector.
Citizens should be given an accurate portrayal of risk, without
overstating the threat or providing false assurances of security. Risk
communication principles have been used in a variety of public warning
contexts, from alerting the public to severe weather, to less
commonplace warnings of infectious disease outbreaks. In general, these
principles seek to maximize public safety by ensuring the public has
sufficient information to determine what actions to take to prevent or
respond to emergencies. Appropriately warning the public of threats can
help save lives and reduce costs of disasters. Federal, state and local
officials and risk management experts who participated in an April 2008
Comptroller General's forum on strengthening the use of risk management
principles in homeland security identified and ranked the challenges in
applying these principles. Improving risk communication to the public
was one of the top three challenges identified by the forum
participants.[Footnote 63]
Our prior work identified several instances when risk communication
proved less than effective. For example, during the 2004-2005 flu
season, demand for the flu vaccine exceeded supply, and information
about future vaccine availability was uncertain (as could happen in a
future pandemic). Although CDC communicated regularly through a variety
of media as the situation evolved, state and local officials identified
several communications lessons. These included the need for consistency
among federal, state, and local communications, the importance of using
diverse media to reach different audiences, and the importance of
disseminating clear, updated information when responding to changing
circumstances.[Footnote 64] Another example, from our October 1999
report on DOD's anthrax vaccine immunization program, illustrated the
importance of providing accurate and sufficient information to
personnel. Although DOD and the military services used a variety of
measures to educate military personnel about the program, military
personnel wanted more information on the program, and over one-half of
respondents that participated in our survey said that the information
they received was less than moderately helpful or that they did not
receive any information.[Footnote 65]
The National Pandemic Implementation Plan emphasizes that government
and public health officials must communicate clearly and continuously
with the public throughout a pandemic. The plan recognizes that timely,
accurate, credible, and coordinated messages will be necessary. The
federal government has undertaken a number of communications efforts to
provide information on a possible pandemic and how to prepare for it.
HHS (including CDC), DHS, and other federal agencies have provided a
variety of influenza pandemic information and guidance for states and
local communities through Web sites and meetings with states. These
efforts included:
* establishing an influenza pandemic Web site [hyperlink,
http://www.pandemicflu.gov];
* including pandemic information on another Web site, Lessons Learned
Information Sharing System (LLIS) [hyperlink, http://www.llis.dhs.gov],
which is a national network of lessons learned and best practices for
emergency responders and homeland security officials;
* sponsoring state pandemic summits with all 50 states and additional
regional state workshops;
* disseminating pandemic preparedness checklists for workplaces,
individuals and families, schools, health care, community
organizations, and state and local governments; and:
* providing additional guidance for the public, such as on pandemic
vaccine targeting and allocation and pre-pandemic community
planning.[Footnote 66]
There are established coordination networks that are being used to
provide information to state and local governments and to the private
sector about pandemic planning and preparedness. For example, the FEBs
are charged with providing timely and relevant information to support
emergency preparedness and response coordination, and OPM expects the
boards to establish notification networks and communications plans to
be used in emergency and nonemergency situations. The boards are also
expected to disseminate relevant information received from OPM and
other agencies regarding emergency preparedness information and to
relay local emergency situation information to parties such as OPM, FEB
members, media, and state and local government authorities. FEB
representatives generally viewed the boards as an important
communications link between Washington and the field and among field
agencies. Each of the selected boards we reviewed reported conducting
communications activities as a key part of its emergency support
service. In addition, critical infrastructure coordinating councils
have been also primarily used as a means to share information and
develop pandemic-specific guidance across the industry sectors, such as
banking and finance and telecommunications, and across levels of
government.
However, as noted earlier, state and local officials from all of the
states and localities we interviewed wanted additional federal
influenza pandemic guidance from the federal government on specific
topics, such as implementing community interventions, fatality
management, and facilitating medical surge. Although the federal
government has issued some guidance, 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. 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.
Performance Monitoring and Accountability for Pandemic Preparedness
Needs Strengthening:
As indicated earlier, in August 2007 we reported that although the
National Pandemic Strategy and Implementation Plan identified the
overarching goals and objectives for pandemic planning, the documents
had some gaps. 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. This
lack of clear linkages 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. For example, most of the action
items' performance measures consist of actions to be completed, such as
guidance developed and disseminated. Further, 18 of the action items
have no measure of performance associated with them. In addition, 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.
This is further complicated by the lack of a description of the
financial resources needed to implement the action items, which is one
of six characteristics of an effective national strategy.
We also found that some action items, 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. Although the plan specifies actions to be carried out by
states, local jurisdictions, and other entities, including the private
sector, it gives no indication of how these actions will be monitored,
how their completion will be ensured, or who will be responsible for
making sure that these actions are completed. Also, it appears that
HSC's determination of completeness has not been accurately applied for
all of the action items. Several of the action items that were reported
by the HSC as being completed were still in progress. For example, our
June 2007 report on U.S. agencies' international efforts to forestall
an influenza pandemic found that eight of the plan's international-
related action items included in the HSC's progress report as completed
either did not directly address the associated performance measure or
did not indicate that the completion deadline had been met.[Footnote
67] As stated earlier, we are currently assessing the implementation of
the plan.
We have also reported that, although DOD instituted reporting
requirements for its components responsible for implementing 31 action
items tasked to DOD in the National Pandemic Implementation Plan, there
were not similar oversight mechanisms in place for pandemic-related
tasks that were not specifically part of the National Plan.[Footnote
68] For example, DOD did not require DOD components to report on their
development or revision of their continuity of operations plans in
preparation for an influenza pandemic. Over time, a lack of clear lines
of authority, oversight mechanisms, and goals and performance measures
could hamper the leadership's abilities to ensure that planning efforts
across the department are progressing as intended as DOD continues its
influenza pandemic planning and preparedness efforts. Additionally,
without clear departmentwide goals, it would be difficult for all DOD
components to develop effective plans and guidance. In response to our
recommendation, DOD designated an official to lead DOD's pandemic
efforts, established a Pandemic Influenza Task Force, and communicated
this information throughout the department. DOD also assigned
responsibility to the U.S. Northern Command for directing, planning,
and synchronizing DOD's global response to an influenza pandemic and
disseminated this information throughout the department.
There have been some other instances where performance and
accountability has been strengthened. The FEBs have recently
established performance measures for their emergency support role. In
our May 2007 report, we recommended that OPM continue its efforts to
establish performance measures and accountability for the emergency
support responsibilities of the FEBs before, during, and after an
emergency event that affects the federal workforce outside Washington,
D.C.[Footnote 69] In response to our recommendation, the FEB strategic
plan for fiscal years 2008 through 2012 includes operational goals with
associated measures for its emergency preparedness, security, and
employee safety line of business. The data intended to support these
measures include methods such as stakeholder and participant surveys,
participant lists, and emergency preparedness test results.
In providing funding to states and certain localities to help them to
prepare for a pandemic, HHS has instituted a number of accountability
requirements. As described above, HHS received $5.62 billion in
supplemental appropriations specifically available for pandemic
influenza-related purposes in fiscal year 2006. As shown in figure 4, a
total of $770 million, or about 14 percent of the supplemental
appropriations, went to states and localities for preparedness
activities. Of the $770 million, $600 million was specifically provided
by Congress for state and local planning and exercising. The HHS
pandemic funding was administered by CDC and required all 50 states and
3 localities to, among other things, develop influenza pandemic plans
and conduct influenza pandemic exercises. According to CDC officials,
all 50 states and the localities that received direct funding have met
these requirements.
Concluding Observations:
Strengthening preparedness for large-scale public health emergencies,
including the possibility of an influenza pandemic, is one of the
issues that we identified as among those needing the urgent attention
of the new administration and Congress during this transition period.
Although much has been done, many challenges remain, as is evidenced by
the fact that almost half of the recommendations that we have made over
the past 3 years have still not been fully implemented. Given the
change in administration and the associated transition of senior
federal officials, it will be essential for this administration to
continue to exercise and test the shared leadership roles that have
been established between HHS and DHS, as well as the relative roles,
responsibilities, and authorities for a pandemic among the federal
government, state and local governments and the private sector. In the
area of critical infrastructure protection, DHS should continue to work
with other federal agencies and private sector members of the critical
infrastructure coordinating councils to help address the challenges
required to coordinate between the federal and private sectors before
and during a pandemic. These challenges include clarifying 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. To help improve international disease
surveillance and detection efforts, the United States should continue
to work with international organizations and other countries to help
address gaps in available information, which limit the capacity for
comprehensive, well-informed comparisons of risk levels by countries.
Continued leadership focus on pandemic preparedness is particularly
crucial now as the attention on influenza pandemic may be waning as
attention shifts to other more immediate national priorities. In
addition, as leadership changes across the executive branch, the new
administration should recognize that the threat of an influenza
pandemic remains unchanged and should therefore continue to maintain
momentum in preparing the nation for a possible influenza pandemic.
As agreed with your office, we plan no further distribution of this
report until 30 days from its date, unless you publicly announce its
contents earlier. At that time, we will send copies to other interested
parties. In addition, this report is available at no charge on GAO's
Web site at [hyperlink, http://www.gao.gov].
If you or your staff have any further questions about this report,
please contact me at (202) 512-6543 or steinhardtb@gao.gov, or Sarah
Veale, Assistant Director, at (202) 512-6890 or veales@gao.gov. Contact
points for our Offices of Congressional Relations and Public Affairs
may be found on the last page of this report. Major contributors to
this report are listed in appendix III.
Sincerely yours,
Signed by:
Bernice Steinhardt:
Director, Strategic Issues:
[End of section]
Appendix I: Open Recommendations from GAO's Work on an Influenza
Pandemic as of February 2009:
Title and GAO product number: Influenza Pandemic: HHS Needs to Continue
Its Actions and Finalize Guidance for Pharmaceutical Interventions, GAO-
08-671, September 30, 2008;
Summary of open recommendations: 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;
Status: 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.
Title and GAO product number: Influenza Pandemic: Federal Agencies
Should Continue to Assist States to Address Gaps in Pandemic Planning,;
GAO-08-539, June 19, 2008;
Summary of open recommendations: 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;
Status: 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.
Title and GAO product number: Influenza Pandemic: Opportunities Exist
to Address Critical Infrastructure Protection Challenges That Require
Federal and Private Sector Coordination, GAO-08-36, October 31, 2007;
Summary of open recommendations: 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;
Status: 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.
Title and GAO product number: Influenza Pandemic: Further Efforts Are
Needed to Ensure Clearer Federal Leadership Roles and an Effective
National Strategy, GAO-07-781; , August 14, 2007;
Influenza Pandemic: Opportunities Exist to Clarify Federal Leadership
Roles and Improve Pandemic Planning, GAO-07-1257T, September 26, 2007;
Summary of open recommendations: (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;
Status: (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.
Summary of open recommendations: (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;
Status: (2) HSC did not comment on the recommendation and has not
indicated if it plans to implement it.
Title and GAO product number: Avian Influenza: USDA Has Taken Important
Steps to Prepare for Outbreaks, but Better Planning Could Improve
Response, GAO-07-652, June 11, 2007;
Summary of open recommendations: (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;
Status: (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.
Summary of open recommendations: (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;
Status: (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.
Summary of open recommendations: (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;
Status: (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.
Summary of open recommendations: (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;
Status: (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.
Summary of open recommendations: (5) The Secretary of Agriculture
should determine the amount of antiviral medication that 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;
Status: (5) USDA officials told us that the National Veterinary
Stockpile now contains enough antiviral medication to protect 3,000
animal health responders for 40 days. However, USDA has yet to
determine the number of individuals that 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.
Source: GAO.
[End of table]
[End of section]
Appendix II: Implemented Recommendations from GAO's Work on an
Influenza Pandemic as of February 2009:
GAO report: Influenza Pandemic: DOD Combatant Commands' Preparedness
Efforts Could Benefit from More Clearly Defined Roles, Resources, and
Risk Mitigation, GAO-07-696, June 20, 2007;
Recommendation: (1) The Secretary of Defense should instruct the
Assistant Secretary of Defense for Homeland Defense and Americas'
Security Affairs to issue guidance that specifies which of the tasks
assigned to DOD in the plan and other pandemic planning tasks apply to
the individual combatant commands, military services, and other
organizations within DOD, as well as what constitutes fulfillment of
these actions;
Actions taken: (1) The 14 national implementation plan tasks assigned
to the Joint Staff as the lead organization within DOD, which includes
tasks to be performed by the combatant commands, have been completed.
According to DOD, the department's Global Pandemic Influenza Planning
Team developed recommendations for the division of responsibilities,
which were included in U.S. Northern Command's global synchronization
plan for pandemic influenza. Additionally, DOD assigned pandemic
influenza- related tasks to the combatant commands in its 2008 Joint
Strategic Capabilities Plan.
Recommendation: (2) The Secretary of Defense should instruct the
Assistant Secretary of Defense for Homeland Defense and Americas'
Security Affairs to issue guidance that specifies U.S. Northern
Command's roles and responsibilities as global synchronizer relative to
the roles and responsibilities of the various organizations leading and
supporting the department's influenza pandemic planning;
Actions taken: (2) Revisions to DOD's 2008 Joint Strategic Capabilities
Plan, as well as guidance from the Secretary of Defense during a
periodic review of U.S. Northern Command's pandemic influenza global
synchronization plan, clarified and better defined U.S. Northern
Command's role as global synchronizer.
Recommendation: (3) The Secretary of Defense should instruct the
Assistant Secretary of Defense for Homeland Defense and Americas'
Security Affairs to work with the Under Secretary of Defense
(Comptroller) to identify the sources and types of resources combatant
commands need to accomplish their influenza pandemic planning and
preparedness activities;
Actions taken: GAO report: (3) DOD, through U.S. Northern Command as
the global synchronizer for pandemic influenza planning, collected
information from the combatant commands on funding requirements related
to pandemic influenza preparedness and submitted this information
through DOD's formal budget and funding process. Through this process,
five of the combatant commands (U.S. Northern Command, U.S. European
Command, U.S. Pacific Command, U.S. Central Command, and U.S.
Transportation Command) obtained about $25 million for fiscal years
2009 through 2013 for pandemic influenza planning and exercises. Future
pandemic influenza-related funding requirements will be addressed
through DOD's established budget process.
Recommendation: (4) The Secretary of Defense should instruct the Joint
Staff to work with the combatant commands to develop options to
mitigate the effects of factors that are beyond the combatant commands'
control;
Actions taken: (4) The combatant commands are increasingly inviting
representatives from the United Nations, including the World Health
Organization and the Food and Agriculture Organization; host and
neighboring nations; and other federal government agencies to exercises
and conferences to share information and fill information gaps.
Additionally, U.S. Northern Command and U.S. Pacific Command, along
with the military services and installations, are increasingly working
and planning with state, local, and tribal representatives. DOD views
updating and reviewing plans to ensure that they are current as a
continuous process driven by changes in policy, science, and
environmental factors.
GAO report: Financial Market Preparedness: Significant Progress Has
Been Made, but Pandemic Planning and Other Challenges Remain, GAO-07-
399, March 29, 2007;
Recommendation: The Chairman, Federal Reserve, the Comptroller of the
Currency, and the Chairman, Securities and Exchange Commission, should
consider taking additional actions to ensure that market participants
adequately prepare for an outbreak, including issuing formal
expectations that business continuity plans for a pandemic should
include measures likely to be effective even during severe outbreaks,
and setting a date by which market participants should have such plans;
Actions taken: In December 2007, the Federal Reserve, in conjunction
with the Federal Financial Institutions Examination Council, issued an
Interagency Statement on Pandemic Planning to each Federal Reserve Bank
and to all banking organizations supervised by the Federal Reserve. The
statement directed those banks to ensure the pandemic plans they have
in place are adequate to maintain critical operations during a severe
outbreak. In December 2007, the Office of the Comptroller of the
Currency, in conjunction with the Federal Financial Institutions
Examination Council, also issued an Interagency Statement on Pandemic
Planning to the national banks, outlining the same requirements for
pandemic plans as the guidance issued by the Federal Reserve. In July
and August of 2007, the Securities and Exchange Commission's Market
Regulation Division issued letters to the major clearing organizations
and exchanges--those covered by the Commission's 2003 Policy Statement
on Business Continuity Planning for Trading Markets--that directed
these organizations to confirm by year-end 2007 that their pandemic
plans are adequate to maintain critical operations during a severe
outbreak.
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 4, 2007;
Recommendation: (1) OPM should initiate discussion with the Department
of Homeland Security and other responsible stakeholders to consider the
feasibility of integrating the federal executive board's (FEB)
emergency support responsibilities into the established emergency
response framework, such as the National Response Plan;
Actions taken: (1) In January 2008, the FEBs were included in the
National Response Framework section on regional support structures that
have the potential to contribute to development of situational
awareness during an emergency. In addition, in August 2007, the FEBs
were integrated into the National Continuity Policy Implementation Plan
issued by the White House Homeland Security Council.
Recommendation: 2) OPM should continue its efforts to establish
performance measures and accountability for the emergency support
responsibilities of the FEBs before, during, and after an emergency
event that affects the federal workforce outside Washington, D.C;
Actions taken: (2) The FEB strategic plan for fiscal years 2008 through
2012 includes operational goals with associated measures for its
emergency preparedness, security, and employee safety line of business.
The data intended to support these measures includes methods such as
stakeholder and participant surveys, participant lists, and emergency
preparedness test results.
Recommendation: (3) OPM, as part of its strategic planning process for
the FEBs, should develop a proposal for an alternative to the current
voluntary contribution mechanism that would address the uncertainty of
funding sources for the boards;
Actions taken: (3) In November 2008, OPM submitted a legislative
proposal to provide for interagency funding of FEB operations
nationwide.
Recommendation: (4) OPM should work with FEMA to develop a memorandum
of understanding, or some similar mechanism that formally defines the
FEB role in emergency planning and response;
Actions taken: (4) In addition to integrating the FEBs into national
emergency plans, FEMA and OPM signed a memorandum of agreement on
August 1, 2008. Among other things, the memorandum states that the
federal executive boards and FEMA will work together in carrying out
their respective roles in the promotion of the National Incident
Management System and the National Response Framework.
GAO report: Influenza Pandemic: DOD Has Taken Important Actions to
Prepare, but Accountability, Funding, and Communications Need to be
Clearer and Focused Departmentwide, GAO-06-1042, September 21, 2006;
Recommendation: (1) The Secretary of Defense should instruct the
Assistant Secretary of Defense for Homeland Defense, as the individual
accountable for DOD's influenza pandemic planning and preparedness
efforts, to clearly and fully define and communicate departmentwide the
roles and responsibilities of the organizations that will be involved
in DOD's efforts, with clear lines of authority; the oversight
mechanisms, including reporting requirements, for all aspects of DOD's
influenza pandemic planning efforts, to include those tasks that are
outside of the national implementation plan; and the goals and
performance measures for DOD's planning and preparedness efforts;
Actions taken: (1) The Deputy Secretary of Defense verbally designated
the Assistant Secretary of Defense for Homeland Defense, working with
the Assistant Secretary of Defense for Health Affairs, to lead DOD's
pandemic influenza efforts and established a Pandemic Influenza Task
Force. This information was communicated throughout the department when
the Principal Deputy to the Assistant Secretary of Defense for Homeland
Defense and Americas' Security Affairs issued DOD's Implementation Plan
for Pandemic Influenza within the department in a July 2006 memo.
Additionally, U.S. Northern Command was designated as the lead
combatant command for directing, planning, and synchronizing DOD's
global response to an influenza pandemic; this information was
disseminated throughout the department in November 2006.
Recommendation: (2) The Secretary of Defense should instruct the
Assistant Secretary of Defense for Homeland Defense to work with the
Under Secretary of Defense (Comptroller) to establish a framework for
requesting funding for the department's preparedness efforts. The
framework should include the appropriate funding mechanism and controls
to ensure that needed funding for DOD's influenza pandemic preparedness
efforts is tied to the department's goals;
Actions taken: (2) The Office of the Under Secretary of Defense
(Comptroller) is utilizing established protocols for programming funds
related to pandemic influenza preparedness for DOD. Funding requests
for preparedness efforts were submitted as part of the department's
fiscal year 2009 integrated program and budget review, and long-term
funding requests will be included in future budget requests.
Recommendation: (3) The Secretary of Defense should instruct the
Assistant Secretary of Defense for Health Affairs to clarify DOD's
guidance to explicitly define whether or how all types of personnel--
including DOD's military and civilian personnel, contractors,
dependents, and beneficiaries--would be included in DOD's distribution
of vaccines and antivirals, and communicate this information
departmentwide;
Actions taken: (3) In August 2007, DOD issued additional guidance
related to the distribution of its vaccine and antiviral stockpiles in
the event of an influenza pandemic.
Recommendation: (4) The Secretary of Defense should instruct the
Assistant Secretary of Defense for Public Affairs to implement a
comprehensive and effective communications strategy departmentwide that
is transparent as to what actions each group of personnel should take
and the limitations of the efficacy, risks, and potential side effects
of vaccines and antivirals;
Actions taken: (4) DOD has updated its publicly available pandemic
influenza Web site, to include links to the Military Vaccine Agency,
which provides information on the risks and side effects of vaccines.
Source: GAO.
[End of table]
[End of section]
Appendix III: GAO Contact and Staff Acknowledgments:
GAO Contact:
Bernice Steinhardt, (202) 512-6543 or steinhardtb@gao.gov:
Staff Acknowledgments:
In addition to the contact named above, major contributors to this
report include Sarah Veale, Assistant Director; Maya Chakko; Susan
Sato; Mark Ryan; Kara Marshall; and members of GAO's Pandemic Working
Group.
[End of section]
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and Administrative Capacity Should Improve National Disaster Response.
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2007.
The Federal Workforce: Additional Steps Needed to Take Advantage of
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Financial Market Preparedness: Significant Progress Has Been Made, but
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Footnotes:
[1] GAO's 2009 Congressional and Presidential Transition Web site:
http://www.gao.gov/transition_2009.
[2] House Committee on Homeland Security,Getting Beyond Getting Ready
for Pandemic Influenza, a report prepared by the majority staff, 111th
Cong., 1st sess., January 2009.
[3] Issued in January 2008 by the Department of Homeland Security (DHS)
and effective in March 2008, the NRF is a guide to how the nation
conducts all-hazards incident response and replaces the National
Response Plan. It focuses on how the federal government is organized to
support communities and states in catastrophic incidents. The NRF
builds upon the National Incident Management System, which provides a
national template for managing incidents.
[4] Antivirals can prevent or reduce the severity of a viral infection,
such as influenza. Vaccines are used to stimulate the production of an
immune system response to protect the body from disease.
[5] The six characteristics of an effective national strategy include:
(1) purpose, scope, and methodology, (2) problem definition and risk
assessment, (3) goals, subordinate objectives, activities, and
performance measures, (4) resources, investments, and risk management,
(5) organizational roles, responsibilities, and coordination, and (6)
integration and implementation.
[6] Avian influenza viruses are classified as either "low pathogenic"
or "highly pathogenic" based on their genetic features and the severity
of the disease they cause in poultry. Highly pathogenic avian influenza
viruses are associated with high morbidity and mortality in poultry.
Health experts are concerned that should highly pathogenic H5N1 or
another subtype, to which humans have no immunity, develop the capacity
to spread easily from person to person, an influenza pandemic could
occur in humans.
[7] GAO, Influenza Pandemic: Further Efforts Are Needed to Ensure
Clearer Federal Leadership Roles and an Effective National Strategy,
[hyperlink, http://www.gao.gov/products/GAO-07-781] (Washington, D.C.:
August 14, 2007).
[8] Congressional Budget Office, A Potential Influenza Pandemic:
Possible Macroeconomic Effects and Policy Issues (Washington, D.C.,
December 8, 2005; rev. July 27, 2006).
[9] Congressional Budget Office, A Potential Influenza Pandemic: An
Update on Possible Macroeconomic Effects and Policy Issues (Washington,
D.C., May 22, 2006; rev. July 27, 2006).
[10] Andrew Burns, Dominique van der Mensbrugghe, and Hans Timmer,
Evaluating the Economic Consequences of Avian Influenza (Washington
D.C.: World Bank, September 2008).
[11] GAO, Hurricane Katrina: GAO's Preliminary Observations Regarding
Preparedness, Response, and Recovery, [hyperlink,
http://www.gao.gov/products/GAO-06-442T] (Washington, D.C.: Mar. 8,
2006).
[12] GAO, Influenza Pandemic: Opportunities Exist to Clarify Federal
Leadership Roles and Improve Pandemic Planning, [hyperlink,
http://www.gao.gov/products/GAO-07-1257T] (Washington, D.C.: Sept. 26,
2007).
[13] Pub. L. No. 109-295, Title VI.
[14] GAO, Homeland Security: Observations on DHS and FEMA Efforts to
Prepare for and Respond to Major and Catastrophic Disasters and Address
Related Recommendations and Legislation, [hyperlink,
http://www.gao.gov/products/GAO-07-1142T] (Washington, D.C.: July 31,
2007).
[15] [hyperlink, http://www.gao.gov/products/GAO-07-781].
[16] GAO, Avian Influenza: USDA Has Taken Important Steps to Prepare
for Outbreaks, but Better Planning Could Improve Response, [hyperlink,
http://www.gao.gov/products/GAO-07-652] (Washington, D.C.: June 11,
2007).
[17] GAO, Influenza Pandemic: DOD Has Taken Important Actions to
Prepare, but Accountability, Funding, and Communications Need to be
Clearer and Focused Departmentwide, [hyperlink,
http://www.gao.gov/products/GAO-06-1042] (Washington, D.C.: Sept, 21,
2006); and GAO, Influenza Pandemic: DOD Combatant Command's
Preparedness Efforts Could Benefit from More Clearly Defined Roles,
Resources, and Risk Mitigation, [hyperlink,
http://www.gao.gov/products/GAO-07-696] (Washington, D.C.: June 20,
2007).
[18] As operational commanders, DOD's unified combatant commands are an
essential part of the department's influenza pandemic planning. There
are currently nine combatant commands--five with geographical
responsibilities and four with functional responsibilities. A sixth
geographical combatant command--the U.S. Africa Command--became
operational in October 2008.
[19] GAO, Influenza Pandemic: Opportunities Exist to Address Critical
Infrastructure Protection Challenges That Require Federal and Private
Sector Coordination, [hyperlink, http://www.gao.gov/products/GAO-08-36]
(Washington, D.C.: Oct. 31, 2007).
[20] The 18 critical infrastructure and key resource sectors are: food
and agriculture; banking and finance; chemical; commercial facilities;
commercial nuclear reactors, materials, and water; dams; defense
industrial base; drinking water and water treatment systems; emergency
services; energy; governmental facilities; information technology;
national monuments and icons; postal and shipping; public health and
healthcare; telecommunications; transportation systems; and critical
manufacturing. Critical infrastructure are systems and assets, whether
physical or virtual, so vital to the United States that their
incapacity or destruction would have a debilitating effect on national
security, national economic security, and national public health or
safety, or any combination of those matters. Key resources are publicly
or privately controlled resources essential to minimal operations of
the economy or government, including individual targets whose
destruction would not endanger vital systems but could create a local
disaster or profoundly damage the nation's morale or confidence.
[21] [hyperlink, http://www.gao.gov/products/GAO-08-36].
[22] [hyperlink, http://www.gao.gov/products/GAO-08-36].
[23] GAO, The Federal Workforce: Additional Steps Needed to Take
Advantage of Federal Executive Boards' Ability to Contribute to
Emergency Operations, [hyperlink, http://www.gao.gov/products/GAO-07-
515] (Washington, D.C.: May 4, 2007).
[24] GAO, Emerging Infectious Diseases: Review of State and Federal
Disease Surveillance Efforts, [hyperlink,
http://www.gao.gov/products/GAO-04-877] (Washington, D.C.: Sept. 30,
2004) and GAO, Information Technology: Federal Agencies Face Challenges
in Implementing Initiatives to Improve Public Health Infrastructure,
[hyperlink, http://www.gao.gov/products/GAO-05-308] (Washington, D.C.:
June 10, 2005).
[25] GAO, Influenza Pandemic: Efforts Under Way to Address Constraints
on Using Antivirals and Vaccines to Forestall a Pandemic, [hyperlink,
http://www.gao.gov/products/GAO-08-92] (Washington, D.C.: Dec. 21,
2007).
[26] [hyperlink, http://www.gao.gov/products/GAO-07-652].
[27] [hyperlink, http://www.gao.gov/products/GAO-08-92].
[28] United Nations System Influenza Coordinator and the World Bank,
Responses to Avian Influenza and State of Pandemic Readiness, Fourth
Global Progress Report, (New York, N.Y., and Washington, D.C., October
2008).
[29] Of the 178 countries that UNSIC surveyed, 148 of those surveyed
responded to the entire survey for an overall response rate of
approximately 83 percent, whereas 30 of those surveyed did not respond.
105 countries, or 75 percent of 140 respondents addressing surveillance
systems, reported having an operational surveillance system capable of
detecting highly pathogenic avian influenza.
[30] GAO, Influenza Pandemic: Efforts to Forestall Onset Are Under Way;
Identifying Countries at Greatest Risk Entails Challenges, [hyperlink,
http://www.gao.gov/products/GAO-07-604] (Washington, D.C.: June 20,
2007).
[31] Of the 178 countries that UNSIC surveyed, 148 of those surveyed
responded to the entire survey for an overall response rate of
approximately 83 percent, whereas 30 of those surveyed did not respond.
95 countries, or approximately 68 percent of 139 respondents addressing
surveillance systems, had actually conducted a risk assessment.
[32] [hyperlink, http://www.gao.gov/products/GAO-07-604].
[33] GAO, Catastrophic Disasters: Enhanced Leadership, Capabilities,
and Accountability Controls Will Improve the Effectiveness of the
Nation's Preparedness, Response, and Recovery System, [hyperlink,
http://www.gao.gov/products/GAO-06-618] (Washington, D.C.: Sept 6,
2006).
[34] Interministerial Influenza Commission, Belgian pandemic flu
preparedness plan, Version 1 (Belgium: July 2006).
[35] Inter-ministerial Avian Influenza Committee, Pandemic Influenza
Preparedness Action Plan of the Japanese Government (Japan: rev.
October 2007).
[36] Riksrevisionen, Swedish National Audit Office, Pandemics--
Managing Threats to Human Health (Sweden: February 2008).
[37] United Kingdom Cabinet Office, National Risk Register (London,
U.K.: 2008).
[38] Of the 178 countries that UNSIC surveyed, 148 of those surveyed
responded to the entire survey for an overall response rate of
approximately 83 percent, whereas 30 of those surveyed did not respond.
Of 145 respondents addressing pandemic planning 141 countries, or 97
percent, said that they had a pandemic plan in place. Four respondents
from Africa indicated that they did not have a pandemic plan.
[39] A comparison of countries that replied to UNSIC's surveys in 2007
and 2008 showed that 34 of 69 respondents reported having conducted a
simulation in 2008 that had not done so in 2007.
[40] The six characteristics of an effective national strategy include:
(1) purpose, scope, and methodology, (2) problem definition and risk
assessment, (3) goals, subordinate objectives, activities, and
performance measures, (4) resources, investments, and risk management,
(5) organizational roles, responsibilities, and coordination, and (6)
integration and implementation. GAO, Combating Terrorism: Evaluation of
Selected Characteristics in National Strategies Related to Terrorism,
[hyperlink, http://www.gao.gov/products/GAO-04-408T] (Washington, D.C.:
Feb. 3, 2004).
[41] We conducted site visits to the five most populous states
including California, Florida, Illinois, New York, and Texas for a
number of reasons, including that these states constituted over one-
third of the United States population, received over one-third of the
total funding from HHS and DHS that could be used for planning and
exercising efforts, and were likely entry points for individuals coming
from another country given that the states either bordered Mexico or
Canada or contained major ports, or both. Within each state, we also
interviewed officials at 10 localities, which consisted of five urban
areas and five rural counties.
[42] Departments of Health and Human Services and Homeland Security and
other agencies, Assessment of States' Operating Plans to Combat
Pandemic Influenza: Report to Homeland Security Council, (Washington,
D.C.: January 2009).
[43] City Auditor's Office, City of Kansas City, Missouri, Performance
Audit: Pandemic Flu Preparedness (October 2007).
[44] National Governors Association Center for Best Practices, Issue
Brief: Pandemic Preparedness in the States--An Assessment of Progress
and Opportunity (September 2008).
[45] GAO, Financial Market Preparedness: Significant Progress Has Been
Made, but Pandemic Planning and Other Challenges Remain, [hyperlink,
http://www.gao.gov/products/GAO-07-399] (Washington, D.C.: March 29,
2007).
[46] A standard of care is the diagnostic and treatment process that a
provider should follow for a certain type of patient or illness, or
certain clinical circumstances. It is how similarly qualified health
care providers would manage the patient's care under the same or
similar circumstances.
[47] GAO, Emergency Management Assistance Compact: Enhancing EMAC's
Collaborative and Administrative Capacity Should Improve National
Disaster Response, [hyperlink, http://www.gao.gov/products/GAO-07-854]
(Washington, D.C.: June 29, 2007).
[48] GAO, Influenza Pandemic: HHS Needs to Continue Its Actions and
Finalize Guidance for Pharmaceutical Interventions, [hyperlink,
http://www.gao.gov/products/GAO-08-671] (Washington, D.C.: Sept. 30,
2008).
[49] GAO, Emergency Preparedness: States Are Planning for Medical
Surge, but Could Benefit from Shared Guidance for Allocating Scarce
Medical Resources, [hyperlink, http://www.gao.gov/products/GAO-08-668]
(Washington, D.C.: June 13, 2008).
[50] [hyperlink, http://www.gao.gov/products/GAO-08-668].
[51] [hyperlink, http://www.gao.gov/products/GAO-08-539].
[52] Department of Health and Human Services, Pandemic Influenza
Implementation Plan (November 2006).
[53] [hyperlink, http://www.gao.gov/products/GAO-08-92].
[54] Congressional Budget Office, U.S. Policy Regarding Pandemic-
Influenza Vaccines (Washington, D.C.: September 2008).
[55] [hyperlink, http://www.gao.gov/products/GAO-08-671].
[56] The standard egg-based technology is essentially the same, whether
producing seasonal or influenza pandemic vaccines. However, with egg-
based technology, an influenza pandemic vaccine would require at least
6 months to produce.
[57] Cell-based vaccines hold the potential to shorten the time between
the identification of a pandemic virus and full-scale production of the
vaccine for the U.S. population. In place of eggs, cell-based vaccine
production uses laboratory-grown cell lines that can host a growing
virus.
[58] HHS, Pandemic Planning Update VI: A Report from Secretary Michael
O. Leavitt, (Washington, D.C.: Jan. 8, 2009).
[59] Congressional Budget Office, U.S. Policy Regarding Pandemic-
Influenza Vaccines.
[60] HHS has launched studies to determine how long the stockpiled pre-
pandemic vaccines remain safe and effective, but in the meanwhile it
assumes a 2-year shelf life.
[61] HHS, Guidance on Antiviral Drug Use during an Influenza Pandemic
(Washington, D.C.: Dec. 16, 2008).
[62] [hyperlink, http://www.gao.gov/products/GAO-07-652].
[63] GAO, Highlights of a Forum: Strengthening the Use of Risk
Management Principles in Homeland Security, [hyperlink,
http://www.gao.gov/products/GAO-08-627SP] (Washington, D.C.: April
2008).
[64] GAO, Influenza Vaccine: Shortages in 2004-05 Season Underscore
Need for Better Preparation, [hyperlink,
http://www.gao.gov/products/GAO-05-984] (Washington, D.C.: Sept. 30,
2005).
[65] GAO, Medical Readiness: DOD Continues to Face Challenges in
Implementing Its Anthrax Vaccine Immunization Program, [hyperlink,
http://www.gao.gov/products/GAO/T-NSIAD-00-157] (Washington, D.C.: Apr.
13, 2000).
[66] Department of Health and Human Services and Department of Homeland
Security, Guidance on Allocating and Targeting Pandemic Influenza
Vaccine (July 23, 2008) and Department of Health and Human Services and
Centers for Disease Control and Prevention, Interim Pre-Pandemic
Planning Guidance: Community Strategy for Pandemic Influenza Mitigation
in the United States (February 2007).
[67] [hyperlink, http://www.gao.gov/products/GAO-07-604].
[68] [hyperlink, http://www.gao.gov/products/GAO-06-1042].
[69] [hyperlink, http://www.gao.gov/products/GAO-07-515].
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