Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer
Federal Leadership Roles and an Effective National Strategy
(14-AUG-07, GAO-07-781).
An influenza pandemic is a real and significant potential threat
facing the United States and the world. Pandemics occur when a
novel virus emerges that can easily be transmitted among humans
who have little immunity. In 2005, the Homeland Security Council
(HSC) issued a National Strategy for Pandemic Influenza and, in
2006, an Implementation Plan. Congress and others are concerned
about the federal government's preparedness to lead a response to
an influenza pandemic. This report assesses how clearly federal
leadership roles and responsibilities are defined and the extent
to which the Strategy and Plan address six characteristics of an
effective national strategy. To do this, GAO analyzed key
emergency and pandemic-specific plans, interviewed agency
officials, and compared the Strategy and Plan with the six
characteristics GAO identified.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-07-781
ACCNO: A74347
TITLE: Influenza Pandemic: Further Efforts Are Needed to Ensure
Clearer Federal Leadership Roles and an Effective National
Strategy
DATE: 08/14/2007
SUBJECT: Critical infrastructure
Emergency management
Emergency preparedness
Emergency response plans
Federal/state relations
Homeland security
Infectious diseases
Influenza
Pandemic
Program evaluation
Public health
Strategic planning
National Response Plan
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GAO-07-781
* [1]Results in Brief
* [2]Background
* [3]All-Hazards Emergency Management Policies Provide the Overar
* [4]The Executive Branch Has Taken Other Steps to Prepare for a
* [5]Federal Government Leadership Roles and Responsibilities Nee
* [6]The Strategy and Plan Do Not Clarify Leadership Roles and Re
* [7]Additional Key Leadership Roles and Responsibilities Are Evo
* [8]Recent Congressional Actions Addressed Leadership Roles and
* [9]Pandemic and All-Hazards Preparedness Act and Its
Implementa
* [10]Post-Katrina Reform Act and Its Implementation
* [11]Rigorous and Robust Exercises Are Important for Testing Fede
* [12]The National Strategy and Its Implementation Plan Do Not Add
* [13]The Strategy and Plan Partially Address Purpose, Scope, and
* [14]Strategy and Plan Address Problem Definition and Risk Assess
* [15]The Strategy and Plan Partially Address Goals, Objectives, A
* [16]The Strategy and Plan Do Not Address Resources, Investments,
* [17]The Strategy and Plan Partially Address Organizational Roles
* [18]The Strategy and Plan Partially Address Integration and Impl
* [19]Conclusions
* [20]Recommendations for Executive Action
* [21]Agency Comments and Our Evaluation
* [22]GAO Contact
* [23]Acknowledgments
* [24]GAO's Mission
* [25]Obtaining Copies of GAO Reports and Testimony
* [26]Order by Mail or Phone
* [27]To Report Fraud, Waste, and Abuse in Federal Programs
* [28]Congressional Relations
* [29]Public Affairs
Report to Congressional Requesters
United States Government Accountability Office
GAO
August 2007
INFLUENZA PANDEMIC
Further Efforts Are Needed to Ensure Clearer Federal Leadership Roles and
an Effective National Strategy
GAO-07-781
Contents
Letter 1
Results in Brief 5
Background 9
Federal Government Leadership Roles and Responsibilities Need
Clarification and Testing 15
The National Strategy and Its Implementation Plan Do Not Address All the
Characteristics of an Effective Strategy, Thus Limiting Their Usefulness
as Planning Tools 23
Conclusions 37
Recommendations for Executive Action 39
Agency Comments and Our Evaluation 40
Appendix I Scope and Methodology 42
Appendix II Comments from the Department of Homeland Security 46
Appendix III GAO Contact and Staff Acknowledgments 48
Related GAO Products 49
Tables
Table 1: Summary of Desirable Characteristics for a National Strategy 4
Table 2: Extent to Which the Strategy and Plan Address GAO's Desirable
Characteristics of an Effective National Strategy 7
Table 3: Extent to Which the Strategy and Plan Address GAO's Desirable
Characteristics of an Effective National Strategy 23
Table 4: GAO Desirable Characteristics for a National Strategy 43
Figures
Figure 1: National Strategy and Implementation Plan's Goals, Pillars,
Functional Areas, and Action Items 28
Figure 2: Related National Preparedness Strategies, Initiatives, and Plans
35
Abbreviations
CBO Congressional Budget Office
COOP Continuity of Operations
CRS Congressional Research Service
DHS Department of Homeland Security
DOD Department of Defense DOT Department of Transportation
ESF Emergency Support Function
FCO Federal Coordinating Officer
FEMA Federal Emergency Management Agency
HHS Department of Health and Human Services
HSC Homeland Security Council
NIMS National Incident Management System
NRP National Response Plan
PFO Principal Federal Official
USDA Department of
Agriculture
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separately.
United States Government Accountability Office
Washington, DC 20548
August 14, 2007
The Honorable Judd Gregg
Ranking Member
Committee on the Budget
United States Senate
The Honorable Henry A. Waxman
Chairman
The Honorable Tom Davis
Ranking Member
Committee on Oversight and Government Reform
House of Representatives
The Honorable Bennie G. Thompson
Chairman
Committee on Homeland Security
House of Representatives
An influenza pandemic is a real and significant threat facing the United
States and the world. Pandemics occur when a novel virus emerges that
infects and can be effectively transmitted between humans who have little
immunity to it. Although the timing and severity of the next pandemic is
unpredictable, there is widespread agreement that a pandemic will occur at
some point. Three influenza pandemics occurred in the 20th century.
Notable among these was the influenza pandemic of 1918, called the
"Spanish flu," which killed over 50 million people worldwide, including
over 675,000 in the United States. Pandemics have spread worldwide within
months, and a future pandemic is expected to spread even more quickly
given modern travel patterns. While health experts cannot predict with
certainty which strain of influenza virus will be involved in the next
pandemic, the avian influenza virus that began in Hong Kong in 1997, known
as H5N1, could lead to a pandemic if it acquires the genetic ability to
spread efficiently from person to person. An influenza pandemic is a real
and significant threat facing the United States and the world. Pandemics
occur when a novel virus emerges that infects and can be effectively
transmitted between humans who have little immunity to it. Although the
timing and severity of the next pandemic is unpredictable, there is
widespread agreement that a pandemic will occur at some point. Three
influenza pandemics occurred in the 20th century. Notable among these was
the influenza pandemic of 1918, called the "Spanish flu," which killed
over 50 million people worldwide, including over 675,000 in the United
States. Pandemics have spread worldwide within months, and a future
pandemic is expected to spread even more quickly given modern travel
patterns. While health experts cannot predict with certainty which strain
of influenza virus will be involved in the next pandemic, the avian
influenza virus that began in Hong Kong in 1997, known as H5N1, could lead
to a pandemic if it acquires the genetic ability to spread efficiently
from person to person.
Unlike incidents that are discretely bounded in space or time (e.g., most
natural or man-made disasters), a 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.
An influenza pandemic could result in 200,000 to 2 million deaths in the
United States, depending on its severity. Further, an influenza pandemic
Unlike incidents that are discretely bounded in space or time (e.g., most
natural or man-made disasters), a 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.
An influenza pandemic could result in 200,000 to 2 million deaths in the
United States, depending on its severity. Further, an influenza pandemic
could have major impacts on society and the economy. According to a study
by the Congressional Budget Office (CBO), a severe pandemic (similar to
the 1918 pandemic) could result in a 5 percent reduction of the gross
domestic product in the United States over the subsequent year. Further,
an influenza pandemic could cause high rates of absences in schools and
workplaces. According to the Centers for Disease Control and Prevention,
in a severe pandemic, absences attributable to illness, the need to care
for ill family members, and fear of infection may reach 40 percent during
the peak weeks of a community outbreak, with lower rates of absence during
the weeks before and after the peak.
To date, the H5N1 virus has been confirmed in birds in 60 nations, up from
16 nations reported in May 2005. There have been numerous cases where the
virus has been transmitted from birds to humans, and although there have
been isolated instances of human-to-human transmission, the virus has not
yet transmitted efficiently from person to person. From January 2003
through July 25, 2007, the World Health Organization reported more than
300 confirmed human cases, and more than 190 of these people in 12
countries have died.
To address the potential threat of an influenza pandemic, the President
and his Homeland Security Council (HSC) issued two planning documents. The
first of these, the National Strategy for Pandemic Influenza (Strategy),
was issued in November 2005 and 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 articulates expectations
for nonfederal entities--including state, local, and tribal governments;
the private sector; international partners; and individuals--to prepare
themselves and their communities. The Implementation Plan for the National
Strategy for Pandemic Influenza (Plan) was issued in May 2006. It is
intended to lay out broad implementation requirements and responsibilities
among the appropriate federal agencies and clearly define expectations for
nonfederal entities. The Plan includes 324 action items related to these
requirements, responsibilities, and expectations.
In light of the problems experienced during prior disasters, such as
Hurricane Katrina, members of Congress and others have expressed concern
about whether the federal government is adequately prepared to lead the
nation in planning for and responding to an influenza pandemic. In
response to your request, this report examines the clarity of federal
leadership roles and responsibilities for preparing for and responding to
a pandemic influenza and provides a detailed review of the Strategy and
Plan.
The objectives of this report are to address the extent to which (1)
federal leadership roles and responsibilities for preparing for and
responding to a pandemic are clearly defined and documented and (2) the
Strategy and the Plan address the characteristics of an effective national
strategy. To address the first objective, we analyzed the Strategy and
Plan and reviewed a variety of federal emergency documents, including the
National Response Plan's (NRP) base plan and annexes, the draft
implementation plan developed by the Department of Homeland Security
(DHS), and the implementation plan developed by the Department of Health
and Human Services (HHS). We interviewed officials from DHS (including the
Federal Emergency Management Agency (FEMA)), HHS, and others with federal
leadership roles in preparing for and responding to a pandemic, including
the Departments of Agriculture (USDA), Defense (DOD), Transportation
(DOT), and State. Some of these officials were involved in the development
of the Plan. We also interviewed the Vice Commandant of the U.S. Coast
Guard who has been predesignated as the national Principal Federal
Official for pandemic influenza. Additionally, we studied the findings in
prior GAO products as well as reports issued by Congress, the
Congressional Research Service (CRS), CBO, the HSC, DHS's Office of the
Inspector General, and other experts.
For the second objective, we assessed the Strategy and Plan to determine
how well they jointly addressed the six desirable characteristics of an
effective national strategy that we developed in previous work, including
reviewing several elements related to each characteristic. We have used
this methodology to assess and report on the administration's strategies
relating to combating terrorism, rebuilding Iraq, and improving citizens'
financial literacy.^1 National strategies that address these
characteristics offer policymakers and implementing agencies a management
tool that can help ensure accountability and more effective results. Table
1 provides the desirable characteristics and a brief description of each
characteristic.
^1 See GAO, Combating Terrorism: Evaluation of Selected Characteristics in
National Strategies Related to Terrorism, [30]GAO-04-408T (Washington,
D.C.: Feb. 3, 2004); Rebuilding Iraq: More Comprehensive National Strategy
Needed to Help Achieve U.S. Goals, [31]GAO-06-788 (Washington, D.C.: July
11, 2006); and Financial Literacy and Education Commission: Further
Progress Needed to Ensure an Effective National Strategy, [32]GAO-07-100
(Washington, D.C.: Dec. 4, 2006).
Table 1: Summary of Desirable Characteristics for a National Strategy
Desirable characteristic Brief description
Purpose, scope, and methodology Addresses why the strategy was produced,
the scope of its coverage, and the
process by which it was developed.
Problem definition and risk Addresses the particular national
assessment problems and threats the strategy is
directed toward.
Goals, subordinate objectives, Addresses what the strategy is trying to
activities, and performance achieve; steps to achieve those results;
measures as well as the priorities, milestones,
and performance measures to gauge
results.
Resources, investments, and risk Addresses what the strategy will cost,
management the sources and types of resources and
investments needed, and where resources
and investments should be targeted by
balancing risk reductions and costs.
Organizational roles, Addresses who will be implementing the
responsibilities, and strategy, what their roles will be
coordination compared to others, and mechanisms for
them to coordinate their efforts.
Integration and implementation Addresses how a national strategy relates
to other strategies' goals, objectives,
and activities--and to subordinate levels
of government and their plans to
implement the strategy.
Source: GAO.
We rated the Strategy and Plan on each of the characteristics, giving a
rating of "addresses," "partially addresses," or "does not address."
According to our methodology, a strategy "addresses" a characteristic when
it explicitly cites all, or nearly all, elements of the characteristic,
and has sufficient specificity and detail. A strategy "partially
addresses" a characteristic when it explicitly cites one or a few of the
elements of a characteristic, and the documents have sufficient
specificity and detail. It should be noted that the "partially addresses"
category includes a range that varies from explicitly citing most of the
elements to citing as few as one of the elements of a characteristic. A
strategy "does not address" a characteristic when it does not explicitly
cite or discuss any elements of a characteristic, any references are
either too vague or general to be useful, or both. The elements are
provided in appendix I.
We conducted our review from May 2006 through June 2007 in accordance with
generally accepted government auditing standards. Further details on our
scope and methodology are in appendix I. A list of other related GAO
reports on pandemic preparedness, emergency preparedness, and other
related topics is included at the end of this report.^2
Results in Brief
While an influenza pandemic will most likely occur in the future, there is
a high level of uncertainty about when a pandemic might occur and its
level of severity. The administration has taken an active approach to this
potential disaster by developing a Strategy and Plan and has taken a
number of other actions. These include establishing an information
clearinghouse for pandemic information; developing planning guidance and
checklists for governments, businesses, nongovernmental organizations, and
individuals; issuing the Strategy and Plan; and starting work on
completing the action items contained in the Plan. In addition to these
actions, HHS has awarded grants totaling $350 million to state and local
governments for pandemic planning and more than $1 billion to accelerate
development and production of new technologies for influenza vaccines
within the United States. While these approaches have been significant,
considerably more work needs to be done.
To begin with, federal government leadership roles and responsibilities
for preparing for and responding to a pandemic continue to evolve and will
require further clarification and testing before the relationships of the
many leadership positions are well-understood. The Strategy and the Plan
do not specify how the leadership roles and responsibilities would work in
addressing the unique characteristics of a pandemic influenza, which could
occur simultaneously in multiple locations and over a long period, coming
in waves, each lasting weeks or months. A pandemic necessitates a strategy
that extends well beyond health and medical boundaries, to include
sustaining critical infrastructure, private sector activities, the
movement of goods and services across the nation and the globe, and
economic and security considerations. The Strategy and Plan indicate that
both the Secretary of Health and Human Services and the Secretary of
Homeland Security will have leadership responsibilities that are
consistent with the NRP--the former for leading the federal medical
response to a pandemic and the latter for overall domestic incident
management and federal coordination. However, it is not clear how, in a
pandemic, the Secretaries of Health and Human Services and Homeland
Security would share leadership responsibilities in practice. For example,
a pandemic could threaten critical infrastructure, a DHS responsibility,
by removing essential personnel from the workplace for weeks or months,
requiring both a medical response as well as actions to protect and
sustain critical infrastructure. Yet, the Plan does not clearly address
these simultaneous responsibilities or how these roles are to work
together, particularly over an extended period and at multiple locations
across the country. Moreover, under recent legislation, the FEMA
Administrator was designated 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.
^2 In addition to these published reports, GAO has engagements under way
to examine other aspects of preparing for and responding to a pandemic,
including efforts by DHS, HHS, and state and local governments.
In addition to these positions, the NRP includes leadership roles for
Principal Federal Officials (PFO) and Federal Coordinating Officers (FCO).
To assist in planning and coordinating efforts to respond to a pandemic,
in December 2006 the Secretary predesignated a national PFO, and
established five pandemic regions each with a regional PFO and FCO. PFOs
are responsible for facilitating federal domestic incident planning and
coordination, and FCOs are responsible for coordinating federal resource
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.
Most of these leadership roles and responsibilities have not been tested
under pandemic scenarios, leaving unclear how all of these new and
developing relationships would work. According to a 2007 CRS report,
although pandemic influenza scenarios have been used to exercise specific
response elements, such as the distribution of stockpiled medications at
specific locations or jurisdictions, there have been no national exercises
to test a multisector, multijurisdictional response or any exercises to
test the new national leadership structure for pandemic influenza.^3 The
only national multisector pandemic exercise to date was a tabletop
simulation conducted by members of the cabinet in December 2005--prior to
the release of the Plan in May 2006 and the establishment of PFO and FCO
positions for a pandemic.
The Strategy and Plan represent an important first step in guiding the
nation's preparedness and response activities, calling for a series of
actions by federal agencies and expectations for states and communities,
the private sector, global partners, and individuals. However, when viewed
together, the Strategy and Plan do not fully address the six
characteristics of an effective national strategy. Gaps and deficiencies
in these documents are particularly troubling because they can affect the
usefulness of the planning documents to those with key roles to play and
affect their ability to effectively carry out their responsibilities.
^3 Congressional Research Service, Pandemic Influenza: Domestic
Preparedness Efforts, RL 33145 (Washington, D.C.: Feb. 20, 2007).
As shown in table 2, while the Strategy and Plan address one of the
desirable characteristics of an effective national strategy, they do not
address another characteristic and partially address the remaining four
characteristics. For example, the documents address the problem definition
and risk assessment characteristic by identifying the potential problems
associated with a pandemic as well as potential threats, challenges, and
vulnerabilities. However, they did not address the resources, investments,
and risk management characteristic because they do not discuss the
financial resources and investments needed to implement the actions called
for. Therefore, they do not provide a picture of priorities or how
adjustments might be made in view of resource constraints.
Table 2: Extent to Which the Strategy and Plan Address GAO's Desirable
Characteristics of an Effective National Strategy
Partially Does not
Desirable characteristic Addresses addresses address
Clear purpose, scope, and methodology X
Problem definition and risk assessment X
Goals, subordinate objectives, activities, X
and performance measures
Resources, investments, and risk management X
Organizational roles, responsibilities, and X
coordination
Integration and implementation X
Source: GAO analysis of the National Strategy for Pandemic Influenza and
Implementation Plan for the National Strategy for Pandemic Influenza.
The Strategy and Plan partially address the remaining four
characteristics. Some of the gaps we found include the following:
o Purpose, scope and methodology: Key stakeholders, such as state,
local, and tribal governments, were not directly involved in
developing actions and the performance measures that are to assess
progress, even though the Strategy and Plan rely on these
stakeholders' efforts. The Plan contains 17 actions in which
state, local, and tribal governments should lead national and
subnational efforts and identifies another 64 actions where their
involvement is needed.
o Integration and implementation: The Strategy and Plan provide
little detail about how the set of pandemic plans they propose,
such as the individual agencies' pandemic plans, are to be
integrated with other existing national strategies that are to
provide an overall all-hazards framework. For example, although
the Strategy and Plan's leadership framework is consistent with
provisions of the NRP, there are no linkages between the 39
response action items in the plan and the NRP or other
response-related plans.
o Goals, objectives, activities, and performance measures: Most of
the Plan's performance measures are focused on activities, such as
disseminating guidance, and are not always clearly linked to the
goals and objectives described in the Strategy and Plan. This lack
of a clear linkage between the performance measures and intended
results makes it difficult to ascertain whether any progress
beyond the completion of activities has in fact been made. Also,
the Plan does not establish priorities among the 324 actions it
calls for, and although the intent expressed in the Plan is that
it will be updated, there are no mechanisms provided in the Plan
to do so. Further, while officials told us they periodically
report to the HSC the status of the action items for which their
agencies have lead responsibility, there is no prescribed process
for publicly reporting nor is there a process for monitoring
actions led by other entities, such as states and local
governments. In December 2006, the HSC publicly reported on the
status of most of the actions that were to have been completed
within 6 months of the Plan's release. However, some of the
actions the HSC reported as complete are actually still under way,
and other actions that were supposed to be completed were omitted
from the report.
o Organizational roles, responsibilities, and coordination: As
noted earlier, the Strategy and Plan did not clarify how
responsible officials will share leadership responsibilities.
This report contains two recommendations to enhance preparedness
efforts for a possible pandemic. First, we recommend that the
Secretaries of Homeland Security and Health and Human Services
work together to develop and conduct rigorous testing, training,
and exercises for pandemic influenza 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. The second recommendation is that the
HSC establish a specific process and time frame for updating the
Plan. The process should involve key nonfederal stakeholders and
incorporate lessons learned from exercises and other sources. The
Plan can also be improved by including the following information
in the next update: (1) resources and investments needed to
complete the action items and where they should be targeted, (2) a
process and schedule for monitoring and publicly reporting on
progress made on completing the action items, (3) clearer linkages
with other strategies and plans, and (4) clearer descriptions of
relationships or priorities among actions items and greater use of
outcome-focused performance measures.
DHS officials we met with said that they are developing a Federal
Concept Plan for Pandemic Influenza that focuses on federal
interagency tasks and is intended to help ensure coordinated
federal preparation, response, and recovery operations if there is
an outbreak. In May 2007, DHS provided a draft to federal agencies
for review and comment, and officials think it may help address
some of the gaps we identified in the Plan. DHS had not determined
when the Concept Plan would be issued.
We provided a draft of this report to DHS, HHS, and the HSC for
review and comment. DHS provided written comments which are
reprinted in appendix II. In commenting on the draft report, DHS
concurred with the first recommendation and stated that it is
taking action on many of the shortfalls identified in the report.
DHS also provided us with technical comments, which we
incorporated in the report as appropriate.
HHS informed us that it had no comments and concurred with the
draft report. The HSC did not comment on the draft report.
Background
The Strategy lays out three high-level goals to prepare for and
respond to an influenza pandemic: (1) stop, slow, or otherwise
limit the spread of a pandemic to the United States; (2) limit the
domestic spread of a pandemic and mitigate disease, suffering, and
death; and (3) sustain infrastructure and mitigate impact on the
economy and the functioning of society. These goals are
underpinned by three pillars that are intended to guide the
federal government's approach to a pandemic threat: (1)
preparedness and communication, (2) surveillance and detection,
and (3) response and containment. Each pillar describes domestic
and international efforts, animal and human health efforts, and
efforts that would need to be undertaken at all levels of
government and in communities to prepare for and respond to a
pandemic.
The Plan is intended to support the broad framework and goals
articulated in the Strategy by outlining specific steps that
federal departments and agencies should take to achieve these
goals. It also describes expectations regarding preparedness and
response efforts of state and local governments and tribal
entities and the private sector. The Plan's chapters cover
categories of actions that are intended to address major
considerations raised by a pandemic, including protecting human
and animal health; transportation and borders; and international,
security, and institutional considerations. The Plan is not
intended to describe the operational details of how federal
departments and agencies would accomplish their objectives to
support the Strategy. Rather, these operational details are
supposed to be included in the departments' and agencies' pandemic
implementation plans along with additional considerations raised
during a pandemic involving (1) protection of employees, (2)
maintenance of essential functions and services, and (3) the
manner in which departments and agencies would communicate
messages about pandemic planning and respond to their
stakeholders.
All-Hazards Emergency Management Policies Provide the Overarching
Context for the Strategy and Plan
The Homeland Security Act of 2002 required the newly established
DHS to develop a comprehensive National Incident Management System
(NIMS) and a comprehensive NRP.^4 NIMS and the NRP are intended to
provide an integrated all-hazards approach to emergency incident
management. As such, they are expected to form the basis of the
federal response to a pandemic. NIMS defines "how" to manage an
emergency incident. It defines roles and responsibilities of
federal, state, and local responders for emergency incidents
regardless of the cause, size, or complexity of the situation. Its
intent is to establish a core set of concepts, principles,
terminology, and organizational processes to enable effective,
efficient, and collaborative emergency incident management at all
levels. The NRP, on the other hand, defines "what" needs to be
done to manage an emergency incident. It is designed to integrate
federal government domestic prevention, protection, response, and
recovery plans into a single operational plan for all hazards and
all emergency response disciplines. Using the framework provided
by NIMS, the NRP is intended to provide the structure and
mechanisms for national-level policy and operational direction for
domestic incident management where federal support is necessary.
^4 Pub. L. No. 107-296, 116 Stat. 2135 (2002).
States may need federal assistance in the event of a pandemic to
maintain essential services. Upon receiving such requests, the
President may issue emergency or major disaster declarations
pursuant to the Robert T. Stafford Disaster Relief and Emergency
Assistance Act of 1974 (the Stafford Act).^5 The Stafford Act
primarily establishes the programs and processes for the federal
government to provide major disaster and emergency assistance to
state and local governments and tribal nations, individuals, and
qualified private nonprofit organizations. Federal assistance may
include technical assistance, the provision of goods and services,
and financial assistance, including direct payments, grants, and
loans. FEMA is responsible for carrying out the functions and
authorities of the Stafford Act.
The Secretary of Health and Human Services also has authority,
under the Public Health Service Act, to declare a public health
emergency and to take actions necessary to respond to that
emergency consistent with his/her authorities.^6 These actions may
include making grants, entering into contracts, and conducting and
supporting investigations into the cause, treatment, or prevention
of the disease or disorder that caused the emergency. The
Secretary's declaration may also initiate the authorization of
emergency use of unapproved products or approved products for
unapproved uses as well as waiving of certain HHS regulatory
requirements.
The NRP, as revised in May 2006, applies to all incidents
requiring a coordinated federal response. The most severe of these
incidents, termed Incidents of National Significance, must be
personally declared and managed by the Secretary of Homeland
Security. According to the Plan, the Secretary of Homeland
Security may declare a pandemic an Incident of National
Significance, perhaps as early as when an outbreak occurs in
foreign countries but before the disease reaches the United
States. In addition to the base response plan, the NRP has 31
annexes consisting of 15 Emergency Support Function (ESF) annexes,
9 support annexes, and 7 incident annexes. The ESFs are the
primary means through which the federal government provides
support to state, local, and tribal governments, and the ESF
structure provides a mechanism for interagency coordination during
all phases of an incident--some departments and agencies may
provide resources during the early stages, while others would be
more prominent in supporting recovery efforts. The ESFs group
capabilities and resources into the functions that are most likely
needed during actual or potential incidents where coordinated
federal response is required.
^5 The Robert T. Stafford Disaster Relief and Emergency Assistance Act of
1974 is codified, as amended, at 42 U.S.C. S 5121-5207.
^6 The Public Health Service Act is codified, as amended, at 42 U.S.C. S
201-300ii-4.
Of the 15 ESF annexes, ESF-8, the public health and medical
services ESF, would be the primary ESF used for the public health
and medical care aspects of a pandemic involving humans.^7
Although HHS is the lead agency for ESF-8, the ESFs are carried
out through a "unified command" approach and several other federal
agencies, including the Departments of Agriculture, Defense,
Energy, Homeland Security (and the U.S. Coast Guard), Justice, and
Labor, are specifically supporting agencies.
ESF-11 pertains to agriculture and natural resources, and its
purpose includes control and eradication of an outbreak of a
highly contagious or economically devastating animal/zoonotic
disease including avian influenza. The purpose of ESF-11 is to
ensure, in coordination with ESF-8, that
animal/veterinary/wildlife issues in natural disasters are
supported. The Departments of Agriculture and the Interior share
responsibilities as primary agencies for this ESF.^8
FEMA has or shares lead responsibility for several of the ESFs,
including those that would be applicable during a pandemic. For
example, FEMA is the lead agency for ESF-5 (emergency management),
ESF-6 (mass care, housing, and human services), and ESF-14
(long-term community recovery and mitigation) and is the primary
agency for ESF-15 (external affairs). Additionally, FEMA is
responsible for carrying out the functions and authorities of the
Stafford Act.
The incident annexes describe the policies, situations, concept of
operations, and responsibilities pertinent to the type of incident
in question. Included among the seven incident annexes within the
NRP is the Catastrophic Incident Annex.^9 The Catastrophic
Incident Annex could be applicable to a pandemic influenza as it
applies to any incident that results in extraordinary levels of
mass casualties, damage, or disruption severely affecting the
population, infrastructure, environment, economy, national morale,
and/or government functions.
^7 The 15 ESF annexes are in (1) transportation; (2) communications; (3)
public works and engineering; (4) firefighting; (5) emergency management;
(6) mass care, housing, and human services; (7) resource support; (8)
public health and medical services; (9) urban search and rescue; (10) oil
and hazardous materials response; (11) agriculture and natural resources;
(12) energy; (13) public safety and security; (14) long-term community
recovery and mitigation; and (15) external affairs.
^8 ESF-11 supporting agencies include the Departments of Commerce,
Defense, Energy, Justice, and Labor.
^9 The NRP includes the seven incident annexes: biological, catastrophic,
cyber, food and agriculture, nuclear/radiological, oil and hazardous
materials, and terrorism incident law enforcement and investigation.
The NRP also addresses two key leadership positions in the event
of a Stafford Act emergency or major disaster. One official, the
FCO, who can be appointed by the Secretary of Homeland Security on
behalf of the President, manages and coordinates federal resource
support activities related to Stafford Act disasters and
emergencies.^10 The other official, the PFO, is designated by the
Secretary of Homeland Security to facilitate federal support to
established incident command structures and to coordinate overall
federal incident management and assistance activities across the
spectrum of prevention, preparedness, response, and recovery. The
PFO is to provide a primary point of contact and situational
awareness for the Secretary of Homeland Security. While the PFO is
supposed to work closely with the FCO during an incident, the PFO
has no operational authority over the FCO.
The Executive Branch Has Taken Other Steps to Prepare for a Pandemic
The executive branch has also developed tools and guidance to aid
in preparing for and responding to a pandemic influenza. Among
these are the following:
o A Web site, [33]www.pandemicflu.gov , to provide one-stop access
to U.S. government avian and pandemic influenza information. This
site is managed by HHS.
o Planning checklists for state and local governments, businesses,
schools, community organizations, health care providers, and
individuals and families. As of July 2007, there were 16
checklists included on the Web site.^11
^10 For non-Stafford Act incidents, the NRP refers to Federal Resource
Coordinators.
^11 As of July 25, 2007, the checklists included State and Local Pandemic
Influenza Planning Checklist, Pandemic Preparedness Planning for United
States Businesses with Overseas Operations, Business Pandemic Influenza
Planning Checklist, Health Insurer Pandemic Influenza Planning Checklist,
Travel Industry Pandemic Influenza Planning Checklist, Child Care and
Preschool Pandemic Influenza Planning Checklist, School District (K-12)
Pandemic Influenza Planning Checklist, Colleges and Universities Pandemic
Influenza Planning Checklist, Faith-Based and Community Organizations
Pandemic Influenza Planning Checklist, Home Health Care Services Pandemic
Influenza Planning Checklist, Medical Offices and Clinics Checklist,
Emergency Medical Services and Medical Transport Checklist, Hospital
Preparedness Checklist, Long-term Care and Other Residential Facilities
Pandemic Influenza Planning Checklist, and Pandemic Flu Planning Checklist
for Individuals and Families.
o Interim planning guidance for state, local, tribal, and
territorial communities on nonpharmaceutical interventions (i.e.,
other than vaccines and drug treatment) to mitigate an influenza
pandemic. This guidance, called the Interim Pre-pandemic Planning
Guidance: Community Strategy for Pandemic Influenza Mitigation in
the United States, includes a Pandemic Severity Index to
characterize the severity of a pandemic, provides planning
recommendations for specific interventions for a given level of
pandemic severity, and suggests when those interventions should be
started and how long they should be used.
o In March 2006, FEMA issued guidance for federal agencies to
revise their Continuity of Operations (COOP) Plans to address
pandemic threats. COOP plans are intended to ensure that essential
government services are available in emergencies. We testified in
May 2006, on the need for agencies to adequately prepare their
telework capabilities for use during a COOP event.^12
o In September 2006, DHS issued guidance to assist owners and
operators of critical infrastructure and key resources to prepare
for a localized outbreak, as well as a broader influenza
pandemic.^13
In addition to these tools and guidance, other actions included
HHS grant awards totaling $350 million to state and local
governments for pandemic planning and more than $1 billion to
accelerate development and production of new technologies for
influenza vaccines within the United States.
^12 GAO, Continuity of Operations: Agencies Could Improve Planning for
Telework during Disruptions, [34]GAO-06-740T (Washington, D.C.: May 11,
2006).
^13 Department of Homeland Security, Pandemic Influenza Preparedness,
Response, and Recovery Guide for Critical Infrastructure and Key
Resources, (Washington, D.C.: Sept. 19, 2006).
Federal Government Leadership Roles and Responsibilities Need
Clarification and Testing
While the Strategy and Plan describe the broad roles and
responsibilities for preparing for and responding to a pandemic
influenza, they do little to clarify existing emergency response
roles and responsibilities. Instead, the documents restate the
shared roles and responsibilities of the Secretaries of Health and
Human Services and Homeland Security already prescribed by the NRP
and related annexes and plans. These and other leadership roles
and responsibilities continue to evolve, such as with the
establishment of a national PFO and regional PFOs and FCOs and
potential changes from ongoing efforts to revise the NRP. Congress
has also passed legislation to address prior problems that emerged
regarding federal leadership roles and responsibilities for
emergency management that have ramifications for pandemic
influenza. Although pandemic influenza scenarios have been used to
exercise specific response elements, such as the distribution of
stockpiled medications at specific locations or jurisdictions, no
national exercises have tested the new federal leadership
structure for pandemic influenza.^14 The only national multisector
pandemic exercise to date was a tabletop simulation conducted by
members of the cabinet in December 2005, which was prior to the
release of the Plan and the establishment of the PFO and FCO
positions for a pandemic.
The Strategy and Plan Do Not Clarify Leadership Roles and
Responsibilities
The Strategy and Plan do not clarify the specific leadership roles
and responsibilities for a pandemic. Instead, they restate the
existing leadership roles and responsibilities, particularly for
the Secretaries of Homeland Security and Health and Human
Services, prescribed in the NRP--an all-hazards plan for
emergencies ranging from hurricanes to wildfires to terrorist
attacks. However, the leadership roles and responsibilities
prescribed under the NRP may need to operate somewhat differently
because of the characteristics of a pandemic that distinguish it
from other emergency incidents. For example, because a pandemic
influenza is likely to occur in successive waves, planning has to
consider how to sustain response mechanisms for several months to
over a year--issues that are not clearly addressed in the Plan. In
addition, the distributed nature of a pandemic, as well as the
sheer burden of disease across the nation, means that the support
states, localities, and tribal entities can expect from the
federal government would be limited in comparison to the aid it
mobilizes for geographically and temporarily bounded disasters
like earthquakes and hurricanes. Consequently, legal authorities,
roles and responsibilities, and lines of authority at all levels
of government must be clearly defined, effectively communicated,
and well-understood to facilitate rapid and effective decision
making. This is also important for public and private sector
organizations and international partners so everyone can better
understand what is expected of them before and during a pandemic.
^14 Congressional Research Service, Pandemic Influenza.
The Strategy and Plan describe the Secretary of Health and Human
Services as being responsible for leading the medical response in
a pandemic, while the Secretary of Homeland Security is
responsible for overall domestic incident management and federal
coordination. However, since a pandemic extends well beyond health
and medical boundaries, to include sustaining critical
infrastructure, private sector activities, the movement of goods
and services across the nation and the globe, and economic and
security considerations, it is not clear when, in a pandemic, the
Secretary of Health and Human Services would be in the lead and
when the Secretary of Homeland Security would lead.
Specifically, the Plan states that the Secretary of Health and
Human Services, consistent with his/her role under the NRP as the
coordinator for ESF-8, would be responsible for the overall
coordination of the public health and medical emergency response
during a pandemic, including coordinating all federal medical
support to communities; providing guidance on infection control
and treatment strategies to state, local, and tribal entities and
the public; maintaining, prioritizing, and distributing
countermeasures in the Strategic National Stockpile; conducting
ongoing epidemiologic assessment and modeling of the outbreak; and
researching the influenza virus, novel countermeasures, and rapid
diagnostics. The Plan calls for the Secretary to be the principal
federal spokesperson for public health issues, coordinating
closely with DHS on public messaging pertaining to the pandemic.
Also similar to the NRP, the Plan states that the Secretary of
Homeland Security, as the principal federal official for domestic
incident management, would be responsible for coordinating federal
operations and resources; establishing reporting requirements; and
conducting ongoing communications with federal, state, local, and
tribal governments, the private sector, and nongovernmental
organizations. It also states that in the context of response to a
pandemic, the Secretary of Homeland Security would coordinate
overall nonmedical support and response actions, sustain critical
infrastructure, and ensure necessary support to the Secretary of
Health and Human Services' coordination of public health and
medical emergency response efforts. Additionally, the Plan states
that the Secretary of Homeland Security would be responsible for
coordinating the overall response to the pandemic; implementing
policies that facilitate compliance with recommended social
distancing measures; providing for a common operating picture for
all departments and agencies of the federal government; and
ensuring the integrity of the nation's infrastructure, domestic
security, and entry and exit screening for influenza at the
borders.^15
Other DHS responsibilities include operating and maintaining the
National Biosurveillance Integration System, which is intended to
provide an all-source biosurveillance common operating picture to
improve early warning capabilities and facilitate national
response activities through better situational awareness. This
responsibility, however, appears to be both a public health issue
and an overall incident management issue, raising similar issues
about the interrelationship of DHS and HHS roles and
responsibilities. In addition, a pandemic could threaten our
critical infrastructure, such as the capability to deliver
electricity or food, by removing essential personnel from the
workplace for weeks or months.^16 The extent to which this would
be considered a medical response with the Secretary of Health and
Human Services in the lead, or when it would be under the
Secretary of Homeland Security's leadership as part of his/her
responsibility for ensuring that critical infrastructure is
protected, is unclear. According to HHS officials we interviewed,
resolving this ambiguity will depend on several factors, including
how the outbreak occurs and the severity of the pandemic.
Officials from other agencies also need greater clarity about
these roles and responsibilities. For example, USDA is not
planning for DHS to assume the lead coordinating role if an
outbreak of avian flu among poultry occurs sufficient in scope to
warrant a presidential declaration of an emergency or major
disaster.^17 The federal response may be slowed as agencies
resolve their roles and responsibilities following the onset of a
significant outbreak. In addition, although DHS and HHS officials
emphasize that they are working together on a frequent basis,
these roles and responsibilities have not been thoroughly tested
and exercised.
^15 Social distancing includes measures such as limiting public gatherings
or closing buildings to help people avoid exposure to infectious diseases.
^16 Critical infrastructure and key resource sectors include agriculture
and food; banking and finance; chemical; commercial facilities; dams;
defense industrial base; drinking water and water treatment systems;
emergency services; energy; government facilities; information technology;
national monuments and icons; nuclear reactors, materials, and waste;
postal and shipping; public health and health care; telecommunications;
and transportation systems.
^17 GAO, Avian Influenza: USDA Has Taken Important Steps to Prepare for
Outbreaks, but Better Planning Could Improve Response, [35]GAO-07-652
(Washington, D.C.: June 11, 2007).
Additional Key Leadership Roles and Responsibilities Are Evolving and
Untested
The executive branch has several efforts, some completed and
others under way, to strengthen and clarify leadership roles and
responsibilities for preparing for and responding to a pandemic
influenza. However, many of these efforts are new, untested
through exercises, or both. For example, on December 11, 2006, the
Secretary of Homeland Security predesignated the Vice Commandant
of the U.S. Coast Guard as the national PFO for pandemic
influenza, and also established five pandemic regions, each with a
regional PFO.^18 Also, FCOs were predesignated for each of the
regions. In addition to the five regional FCOs, a FEMA official
with significant FCO experience has been selected to serve as the
senior advisor to the national PFO. DOD has selected Defense
Coordination Officers and HHS has selected senior health officials
to work together within this national pandemic influenza
preparedness and response structure.
DHS is taking steps to further clarify federal leadership roles
and responsibilities. Specifically, it is developing a Federal
Concept Plan for Pandemic Influenza, which is intended to identify
specific federal response roles and responsibilities for each
stage of an outbreak. According to DHS, the Concept Plan, which is
based on the Implementation Plan and other related documents,
would also identify "seams and gaps that must be addressed to
ensure integration of all federal departments and agencies prior
to, during, and after a pandemic outbreak in the U.S." According
to DHS officials, they sent a draft to federal agencies in May for
comment and have not yet determined when the Concept Plan will be
issued.
U.S. Coast Guard and FEMA officials we met with recognized that
planning for and responding to a pandemic would require different
operational leadership roles and responsibilities than for most
other emergencies. For example, a FEMA official said that given
the number of people who would be involved in responding to a
pandemic, collaboration between HHS, DHS, and FEMA would need to
be greater than for any other past emergencies. Officials are
starting to build relationships among the federal actors for a
pandemic. For example, some of the federal officials with
leadership roles for an influenza pandemic met during the week of
March 19, 2007, to continue to identify issues and begin
developing solutions. One of the participants, however, told us
that although additional coordination meetings are needed, it may
be challenging since there is no dedicated funding for the staff
working on pandemic issues to participate in these and other
related meetings.
^18 The Secretary of Homeland Security combined the jurisdictions covered
by FEMA's 10 regional offices into 5 pandemic regions.
The national PFO for pandemic influenza said that a draft charter
has also been developed to establish a Pandemic Influenza PFO
Working Group to help identify and address many policy and
operational issues before a pandemic. According to a FEMA
official, some of these issues include staff availability,
protective measures for staff, and how to ensure that the
assistance to be provided under the Stafford Act is implemented
and coordinated in a unified and consistent manner across the
country during a pandemic. As of June 7, 2007, the draft charter
was undergoing some revisions and was expected to be sent to the
Secretary of Homeland Security for review and approval around the
end of June. Additionally, there are plans to identify related
exercises, within and outside of the federal government, to create
a consolidated schedule of exercises for the national PFO for
pandemic influenza and regional PFOs and FCOs to participate in by
leveraging existing exercise plans. DHS officials said that they
expect FEMA would retain responsibility for maintaining this
consolidated schedule.
It is unclear whether the newly established national and regional
positions for a pandemic will further clarify leadership roles.
For example, in 2006, DHS made revisions to the NRP and released a
Supplement to the Catastrophic Incident Annex--both designed to
further clarify federal roles and responsibilities and
relationships among federal, state, and local governments and
responders. However, we reported in February 2007 that these
revisions had not been tested and there was little information
available on the extent to which these and other actions DHS was
taking to improve readiness were operational.^19 Additionally, DHS
is currently coordinating a comprehensive review of the NRP and
NIMS to assess their effectiveness, identify improvements, and
recommend modifications. One of the issues expected to be
addressed during this review is clarifying of roles and
responsibilities of key structures, positions, and levels of
government, including the role of the PFO and that position's
current lack of operational authority during an emergency. The
review is expected to be done, and a revised NRP and NIMS issued,
by the summer of 2007.
^19 GAO, Homeland Security: Management and Programmatic Challenges Facing
the Department of Homeland Security, [36]GAO-07-398T (Washington, D.C.:
Feb. 6, 2007).
Recent Congressional Actions Addressed Leadership Roles and
Responsibilities
In 2006, Congress passed two acts addressing leadership roles and
responsibilities for emergency management--the Pandemic and
All-Hazards Preparedness Act^20 and the Post-Katrina Emergency
Management Reform Act of 2006^21--which were enacted into law on
December 19, 2006 and October 4, 2006, respectively.
Pandemic and All-Hazards Preparedness Act and Its Implementation
The Pandemic and All-Hazards Preparedness Act codifies
preparedness and response federal leadership roles and
responsibilities for public health and medical emergencies that
are now in the NRP by designating the Secretary of Health and
Human Services as the lead federal official for public health and
medical preparedness and response, consistent with the NRP. The
act also requires the Secretary to establish an interagency
agreement, in collaboration with DOD, DHS, DOT, the Department of
Veterans Affairs, and other relevant federal agencies, prescribing
that consistent with the NRP, HHS would assume operational control
of emergency public health and medical response assets in the
event of a public health emergency. Further, the act requires that
the Secretary develop a coordinated National Health Security
Strategy and accompanying implementation plan for public health
emergency preparedness and response. This health security strategy
and accompanying implementation plan are to be completed by 2009
and updated every 4 years.
The act also prescribes several new preparedness responsibilities
for HHS. For example, the Secretary must develop and disseminate
criteria for an effective state plan for responding to a pandemic
influenza. Additionally, the Secretary is required to develop and
require the application of measurable evidence-based benchmarks
and objective standards that measure the levels of preparedness in
such areas as hospitals and state and local public health
security.
The act seeks to further strengthen HHS's public health leadership
role by transferring the National Disaster Medical System from DHS
back to HHS, thus placing these public health resources within
HHS.^22 It also creates the Office of the Assistant Secretary for
Preparedness and Response (replacing the Office of the Assistant
Secretary for Public Health Emergency Preparedness) and
consolidates other preparedness and response functions within HHS
in the new Assistant Secretary's office.
^20 Pub. L. No. 109-417.
^21 Pub. L. No. 109-295, Title VI.
HHS has set up an implementation team involving over 200 HHS staff
to implement the provisions of this act. According to a HHS
official, an interim implementation plan is expected to be made
available for public comment sometime during the summer of 2007.
Post-Katrina Reform Act and Its Implementation
In response to the findings and recommendations from several
reports, the Post-Katrina Emergency Management Reform Act
(referred to as the Post-Katrina Reform Act in this report)
designated the FEMA Administrator as the principal domestic
emergency management advisor to the President, the HSC, and the
Secretary of Homeland Security. Therefore, the FEMA Administrator
also has a leadership role in preparing for and responding to an
influenza pandemic, including key areas such as planning and
exercising. For example, under the Post-Katrina Reform Act, the
FEMA Administrator is responsible for carrying out a national
exercise program to test and evaluate preparedness for a national
response to natural and man-made disasters.
The act made FEMA a distinct entity within DHS for leading and
supporting the nation in a risk-based, comprehensive emergency
management system of preparedness, protection, response, recovery,
and mitigation. As part of the reorganization, DHS transferred
several offices and divisions of its National Preparedness
Directorate to FEMA, including the Offices of Grants and Training
and National Capital Region Coordination.^23 FEMA's National
Preparedness Directorate contains functions related to
preparedness doctrine, policy, and contingency planning and
includes DHS's exercise coordination and evaluation program and
emergency management training. Other transfers included the
Chemical Stockpile Emergency Preparedness Division, Radiological
Emergency Preparedness Program, and the United States Fire
Administration. The reorganization took effect on March 31, 2007,
and it will likely take some time before it is fully implemented
and key leadership positions within FEMA are filled.
^22 The National Disaster Medical System was transferred to DHS from HHS
as part of the Homeland Security Act of 2002 establishing DHS.
^23 On January 18, 2007, DHS provided Congress with a notice of
implementation of the Post-Katrina Reform Act reorganization requirements
and additional organizational changes made under the Homeland Security Act
of 2002.
Rigorous and Robust Exercises Are Important for Testing Federal
Leadership for a Pandemic
Disaster planning, including for a pandemic influenza, needs to be
tested and refined with a rigorous and robust ex ercise program to
expose weaknesses in plans and allow planners to refine them.
Exercises--particularly for the type and magnitude of emergency
incidents such as a severe influenza pandemic for which there is
little actual experience--are essential for developing skills and
identifying what works well and what needs further improvement.
Our prior work examining the preparation for and response to
Hurricane Katrina highlighted the importance of realistic
exercises to test and refine assumptions, capabilities, and
operational procedures; and build upon strengths.^24 In response
to the experiences during Hurricane Katrina, the Post-Katrina
Reform Act called for a national exercise program to evaluate
preparedness of a national response to natural and man-made
disasters.
While pandemic influenza scenarios have been used to exercise
specific response elements and locations, such as for distributing
stockpiled medications, there has been no national exercise to
test a multisector, multijurisdictional response or any exercises
to test the working and operational relationships of the national
PFO and the five regional PFOs and FCOs for pandemic influenza.
According to a CRS report, the only national multisector pandemic
exercise to date was a tabletop simulation involving members of
the federal cabinet in December 2005.^25 This tabletop exercise
was prior to the release of the Plan in May 2006, the
establishment of a national PFO and regional PFO and FCO positions
for a pandemic, and enactment of the Pandemic and All-Hazards
Preparedness Act in December 2006 and the Post-Katrina Reform Act
in October 2006.
^24 GAO, Hurricane Katrina: GAO's Preliminary Observations Regarding
Preparedness, Response, and Recovery, [37]GAO-06-442T (Washington, D.C.:
Mar. 8, 2006).
^25 Congressional Research Service, Pandemic Influenza.
The National Strategy and Its Implementation Plan Do Not Address
All the Characteristics of an Effective Strategy, Thus Limiting
Their Usefulness as Planning Tools
The Strategy and Plan represent important efforts to guide the
nation's preparedness and response activities, setting forth
actions to be taken by federal agencies and expectations for a
wide range of actors, including states and communities, the
private sector, global partners, and individuals. However, the
Strategy and Plan do not address all of the characteristics of an
effective national strategy as we identified in our prior work.
While national strategies necessarily vary in content, the six
characteristics we identified apply to all such planning documents
and can help ensure that they are effective management tools. Gaps
and deficiencies in these documents are particularly troubling in
that a pandemic represents a complex challenge that will require
the full understanding and collaboration of a multitude of
entities and individuals. The extent to which these documents,
that are to provide an overall framework to ensure preparedness
and response to a pandemic influenza, fail to adequately address
key areas, could have critical impact on whether the public and
key stakeholders have a clear understanding and can effectively
execute their roles and responsibilities.
As shown in table 3, the Strategy and its Plan address one of the
six characteristics of an effective national strategy. However,
they only partially address four and do not address one of the
characteristics at all. As a result, the Strategy and Plan fall
short as an effective national strategy in important areas.
Table 3: Extent to Which the Strategy and Plan Address GAO's
Desirable Characteristics of an Effective National Strategy
Partially Does not
Desirable characteristic Addresses addresses address
Clear purpose, scope, and methodology X
Problem definition and risk assessment X
Goals, subordinate objectives, activities, X
and performance measures
Resources, investments, and risk management X
Organizational roles, responsibilities, and X
coordination
Integration and implementation X
Source: GAO analysis of the National Strategy for Pandemic
Influenza and Implementation Plan for the National Strategy for
Pandemic Influenza.
The Strategy and Plan Partially Address Purpose, Scope, and
Methodology
A national strategy should address its purpose, scope, and
methodology, including the process by which it was developed,
stakeholder involvement, and how it compares and contrasts with
other national strategies. Addressing this characteristic helps
make a strategy more useful to organizations responsible for
implementing the strategy, as well as those responsible for
oversight. We found that the Strategy and Plan partially address
this characteristic by describing their purpose and scope.
However, neither document described in adequate detail their
methodology for involving key stakeholders, how they relate to
other national strategies, or a process for updating the Plan.
In describing its purpose, the Strategy states that it was
developed to provide strategic direction for the departments and
agencies of the U.S. government and guide the U.S. preparedness
and response activities to mitigate the impact of a pandemic. In
support of the Strategy, the Plan states that its purpose is to
translate the Strategy into tangible action and direct federal
departments and agencies to take specific, coordinated steps to
achieve the goals of the Strategy and outline expectations for
state, local, and tribal entities; businesses; schools and
universities; communities; nongovernmental organizations; and
international partners.
As a part of its scope, the Plan identifies six major functions:
(1) protecting human health, (2) protecting animal health, (3)
international considerations, (4) transportation and borders, (5)
security considerations, and (6) institutional considerations. The
Plan proposes that departments and agencies undertake a series of
actions in support of these functional areas with operational
details on how departments would accomplish these objectives to be
provided by separate departmental plans. Additionally, the
Strategy and Plan describe the principles and planning assumptions
that guided their development. The Strategy's guiding principles
include recognition of the private sector's integral role and
leveraging global partnerships. The Plan's principles are more
expansive, listing 12 planning assumptions that it identifies as
facilitating its planning efforts. For example, 1 of the
assumptions is that illness rates would be highest among
school-aged children (about 40 percent).
Another element under this characteristic is the involvement of
key stakeholders in the development of the strategy. Neither the
Strategy nor Plan described the involvement of key stakeholders,
such as state, local, and tribal entities, in the development of
the Strategy or Plan, even though they would be on the front lines
in a pandemic and the Plan identifies actions they should
complete. The Plan contains 17 actions calling for state, local,
and tribal governments to lead national and subnational efforts,
and identifies another 64 actions where their involvement is
needed. Officials told us that federal stakeholders had
opportunities to review and comment on the Plan but that state,
local, and tribal entities were not directly involved, although
the drafters of the Plan were generally aware of their concerns.
Stakeholder involvement during the planning process is important
to ensure that the federal government's and nonfederal entities'
responsibilities and resource requirements are clearly understood
and agreed upon. Therefore, the Strategy and Plan may not fully
reflect a national perspective on this critical national issue
since nonfederal stakeholders were not involved in the process to
develop the actions where their leadership, support, or both would
be needed. Further, these nonfederal stakeholders need to
understand their critical roles in order to be prepared to work
effectively under difficult and challenging circumstances.
Both documents address the scope of their coverage and include
several important elements in their discussions, but do not
address how they compare and contrast to other national
strategies. The Strategy recognizes that preparing for a pandemic
is more than a purely federal responsibility, and that the nation
must have a system of plans at all levels of government and in all
sectors outside of government that can be integrated to address
the pandemic threat. It also extends its scope to include the
development of an international effort as a central component of
overall capacity. The Strategy lays out the major functions,
mission areas, and activities considered under the extent of its
coverage. For example, the Strategy's scope is defined as
extending well beyond health and medical boundaries, to include
sustaining critical infrastructure, private sector activities, the
movement of goods and services across the nation and the globe,
and economic and security considerations. Although the Strategy
states that it will be consistent with the National Security
Strategy and the Strategy for Homeland Security, it does not
specify how they are related. The Plan mentions the NRP and states
that it will guide the federal pandemic response. Because a
pandemic would affect all facets of our society, including the
nation's security, it is important to recognize and reflect an
understanding of how these national strategies relate to one
another.
The Plan does not describe a mechanism for updating it to reflect
policy decisions, such as clarifications in leadership roles and
responsibilities and other lessons learned from exercising and
testing or other changes. Although the Plan was developed with the
intent of being initial guidance and being updated and expanded
over time, officials in several agencies told us that specific
processes or time frames for updating and revising it have not
been established. In addition to incorporating lessons learned,
such updates are important in ensuring that the Plan accurately
reflects entities' capabilities and a clear understanding of roles
and responsibilities. Additionally, an update would also provide
the opportunity for input from nonfederal entities that have not
had an opportunity to directly provide input to the Strategy and
Plan.
Strategy and Plan Address Problem Definition and Risk Assessment
National strategies need to reflect a clear description and
understanding of the problems to be addressed, their causes, and
operating environment. In addition, the strategy should include a
risk assessment, including an analysis of the threats to and
vulnerabilities of critical assets and operations. We found that
the Strategy and Plan address this characteristic by describing
the potential problems associated with a pandemic as well as
potential threats and vulnerabilities.
In defining the problem, both documents provide information on
what a pandemic is and how influenza viruses are transmitted, and
explain that a threat stems from an unprecedented outbreak of
avian influenza in Asia and Europe, caused by the H5N1 strain of
the influenza A virus. The President, in releasing the Strategy,
stated that it presented an approach to address the threat of
pandemic influenza, whether it results from the strain currently
in birds in Asia or another influenza virus. Additionally, the
problem definition includes a historical perspective of other
pandemics in the United States.
The Plan used the severity of the 1918 influenza pandemic as the
basis for its risk assessment. A CBO study^26 was used to describe
the possible economic consequences of such a severe pandemic on
the U.S. economy today. While the Plan did not discuss the
likelihood of a severe pandemic or analyze the possibility of
whether the H5N1 strain would be the specific virus strain to
cause a pandemic, it stated that history suggests that a pandemic
would occur some time in the future. As a result, it recognizes
the importance of preparing for an outbreak.
The Strategy and Plan included discussions of the constraints and
challenges involved in a pandemic. For example, the Plan included
challenges such as severe shortfalls in surge capacity in the
nation's health care facilities, limited vaccine production
capabilities, the lack of real-time surveillance among most of the
systems, and the inability to quantify the value of many infection
control strategies.
^26 Congressional Budget Office, A Potential Influenza Pandemic: Possible
Macroeconomic Effects and Policy Issues (Washington, D.C.: Dec. 8, 2005).
In acknowledging the challenges involved in pandemic preparedness,
the Plan also describes a series of circumstances to enable
preparedness, such as viewing pandemic preparedness as a national
security issue, connectivity between communities, and
communicating risk and responsibility. In this regard, the Plan
recognizes that one of the nation's greatest vulnerabilities is
the lack of connectivity between communities responsible for
pandemic preparedness. The Plan specifically cites vulnerabilities
in coordination of efforts between the animal and human health
communities, as well as between the public health and medical
communities. In the case of public health and medical communities,
the public health community has responsibility for communitywide
health promotion and disease prevention and mitigation efforts,
and the medical community is largely focused on actions at the
individual level.
The Strategy and Plan Partially Address Goals, Objectives, Activities,
and Performance Measures
A national strategy should describe its goals and the steps needed
to achieve those results, as well as the priorities, milestones,
and outcome-related performance measures to gauge results.
Identifying goals, objectives, and outcome-related performance
measures aids implementing parties in achieving results and
enables more effective oversight and accountability. We found that
the Strategy and Plan partially address this characteristic by
identifying the overarching goals and objectives for pandemic
planning. However, the documents did not describe relationships or
priorities among the action items, and some of the action items
lacked a responsible entity for ensuring their completion. The
Plan also did not describe a process for monitoring and reporting
on the action items. Further, many of the performance measures
associated with action items were not clearly linked with results
nor assigned clear priorities.^27
The Strategy and Plan identify a hierarchy of major goals,
pillars, functional areas, and specific activities (i.e., action
items), as shown in figure 1. The Plan includes and expands upon
the Strategy's framework by including 324 action items.
^27 Of the 324 action items, 39 were response related with performance
measures requiring certain efforts within a prescribed time frame after an
outbreak and thus not included in the universe of action items assessed
for this purpose. Additionally, there were no performance measures
associated with 18 action items.
Figure 1: National Strategy and Implementation Plan's Goals, Pillars,
Functional Areas, and Action Items
The Plan uses the Strategy's three major goals that are underpinned by
three pillars as its framework and expands on this organizing structure by
presenting chapters on six functional areas with various objectives,
action items, and performance measures. For example, pillar 2,
surveillance and detection, under the transportation and borders
functional area, includes an objective to develop and exercise mechanisms
to provide active and passive surveillance during an outbreak, both within
and outside our borders. Under this objective is an action item for HHS,
in coordination with other specific federal agencies, to develop policy
recommendations for transportation and borders entry and exit protocols,
screening, or both and to review the need to develop domestic response
protocols and screening within 6 months. The item's performance measure is
policy recommendations for response protocols, screening, or both.
While some action items depend on other action items, these linkages are
not always apparent in the Plan. For example, one action item, concerning
the development of a joint strategy for deploying federal health care and
public health assets and personnel, is under the preparedness and
communication pillar. However, another action item concerning the
development of strategic principles for deployment of federal medical
assets is under the response and containment pillar within the same
chapter. While these two action items are clearly related, the plan does
not make a connection between the two or discuss their relationship. An
HHS official who helped draft the Plan acknowledged that while an effort
was made to ensure linkages among action items, there may be gaps in the
linkages among interdependent action items within and across the Plan's
chapters on the six functional areas (i.e., the chapters that contain
action items).
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 and how their completion will be
ensured. For example, one such action item states that "all health care
facilities should develop and test infectious disease surge capacity plans
that address challenges including: increased demand for services, staff
shortages, infectious disease isolation protocols, supply shortages, and
security." Similarly, another action item states that "all Federal, State,
local, tribal, and private sector medical facilities should ensure that
protocols for transporting influenza specimens to appropriate reference
laboratories are in place within 3 months." Yet the plan does not make
clear who will be responsible for making sure that these actions are
completed.
While most of the action items have deadlines for completion, ranging from
3 months to 3 years, the Plan does not identify a process to monitor and
report on the progress of the action items nor does it include a schedule
for reporting progress. Agency officials told us that they had identified
individuals to act as overall coordinators to monitor the action items for
which their agencies have lead responsibility and provide periodic
progress reports to the HSC. However, we could not identify a similar
mechanism to monitor the progress of the action items that fall to state
and local governments or the private sector. The first public reporting on
the status of the action items occurred in December 2006 when the HSC
reported on the status of the action items that were to have been
completed by November 3, 2006--6 months after the release of the Plan. Of
the 119 action items that were to be completed by that time, we found that
the HSC omitted the status of 16 action items. Two of the action items
that were omitted from the report were to (1) establish an interagency
transportation and border preparedness working group and (2) engage in
contingency planning and related exercises to ensure preparedness to
maintain essential operations and conduct missions.
Additionally, we found that several of the action items that were reported
by the HSC as being completed were still in progress. For example, DHS, in
coordination with the Department of State (State), HHS, the Department of
the Treasury (Treasury), and the travel and trade industry, was to tailor
existing automated screening programs and extended border programs to
increase scrutiny of travelers and cargo based on potential risk factors
within 6 months. The measure of performance was to implement enhanced
risk-based screening protocols. Although this action item was reported as
complete, the HSC reported that DHS was still developing risk-based
screening protocols, a major component of this action. A DHS official,
responsible for coordinating the completion of DHS-led action items,
acknowledged that all action items are a work in progress and that they
would continue to be improved, including those items that were listed as
completed in the report. The HSC's report included a statement that a
determination of "complete" does not necessarily mean that work has ended;
in many cases work is ongoing. Instead, the complete determination means
that the measure of performance associated with an action item was met. It
appears that this determination has not been consistently or accurately
applied for all items. Our recent report on U.S. agencies' international
efforts to forestall a pandemic influenza also reported that eight of the
Plan's international-related action items included in the HSC's report
either did not directly address the associated performance measure or did
not indicate that the completion deadline had been met.^28
Most of the Plan's performance measures are focused on activities 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 Strategy and Plan. Most of
the Plan's performance measures consist of actions to be completed, such
as guidance developed and disseminated. 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. Further, 18
of the action items have no measure of performance associated with them.
In addition, the 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.
^28 GAO, Influenza Pandemic: Efforts to Forestall Onset Are Under Way;
Identifying Countries at Greatest Risk Entails Challenges, [38]GAO-07-604
(Washington, D.C.: June 20, 2007).
The Strategy and Plan Do Not Address Resources, Investments, and Risk Management
A national strategy needs to describe what the strategy will cost;
identify where resources will be targeted to achieve the maximum results;
and describe how the strategy balances benefits, risks, and costs.
Guidance on costs and resources needed using a risk management approach
helps implementing parties allocate resources according to priorities,
track costs and performance, and shift resources, as appropriate. We found
that neither the Strategy nor Plan contain these elements.
While neither document addresses the overall cost to implement the Plan,
the Plan refers to the administration's budget request of $7.1 billion and
a congressional appropriation of $3.8 billion to support the objectives of
the Strategy. In November 2005, the administration requested $7.1 billion
in emergency supplemental funding over 3 years to support the
implementation of the Strategy. In December 2005, Congress appropriated
$3.8 billion to support budget requirements to help address pandemic
influenza issues.^29 The Plan states that much of this funding would be
directed toward domestic preparedness and the establishment of
countermeasure stockpile and production capacity, with $400 million
directed to bilateral and multilateral international efforts. However, the
3-year $7.1 billion budget proposal does not coincide with the period of
the Plan. Additionally, whereas the Plan does not allocate funds to
specific action items, our analysis of budget documents indicates that the
funds were allocated primarily toward those action items related to
vaccines and antivirals.
Developing and sustaining the capabilities stipulated in the Plan would
require the effective use of federal, state, and local funds. Given that
funding needs may not be readily addressed through existing mechanisms and
could stress existing government and private resources, it is critical for
the Plan to lay out funding requirements. For example, the Plan states
that one of the primary objectives of domestic vaccine production capacity
would be for domestic manufacturers to produce enough vaccine for the
entire U.S. population within 6 months. However, it states that production
capacity would depend on the availability of future appropriations.
Despite the fact that the production of enough vaccine for the population
would be critical if a pandemic were to occur, the Plan does not provide
even a rough estimate of how much the vaccine could cost for consideration
in future appropriations.
^29 Emergency Supplemental Appropriations to Address Hurricanes in the
Gulf of Mexico and Pandemic Influenza Act of 2006, Division B of Pub.L.
No. 109-148 (2005).
Despite the numerous action items and specific implementing directives and
guidance directed toward federal agencies, states, organizations, and
businesses, neither document addresses what it would cost to complete the
actions that are stipulated. Rather, the Plan states that the local
communities would have to address the medical and nonmedical effects of
the pandemic with available resources, and also that pandemic influenza
response activities may exceed the budgetary resources of responding
federal and state government agencies.
The overall uncertainty of funding to complete action items stipulated in
the Plan has been problematic. For example, there were more than 50
actions in the Plan that were to be completed before the end of 2006 for
which DOD was either a lead or support agency. We reported that because
DOD had not yet requested funding, it was unclear whether DOD could
address the tasks assigned to it in the Plan and pursue its own
preparedness efforts for its workforce departmentwide within current
resources.^30
The Strategy and Plan Partially Address Organizational Roles, Responsibilities,
and Coordination
A national strategy should address which organizations would implement the
strategy, their roles and responsibilities, and mechanisms for
coordinating their efforts. It helps to answer the fundamental question
about who is in charge, not only during times of crisis, but also during
all phases of emergency management, as well as the organizations that will
provide the overall framework for accountability and oversight. This
characteristic entails identifying the specific federal departments,
agencies, and offices involved and, where appropriate, the different
sectors, such as state, local, private, and international sectors. We
found that the Strategy and Plan partially address this characteristic by
containing broad information on roles and responsibilities. But, as we
noted earlier, while the Plan describes coordination mechanisms for
responding to a pandemic, it does not clarify how responsible officials
would share leadership responsibilities. In addition, it does not describe
mechanisms for coordinating preparations and completing the action items,
nor does it describe an overall accountability and oversight framework.
^30 GAO, Influenza Pandemic: DOD Has Taken Important Actions to Prepare,
but Accountability, Funding, and Communications Need to be Clearer and
Focused Departmentwide, [39]GAO-06-1042 (Washington, D.C.: Sept. 21,
2006).
The Strategy identifies lead agencies for preparedness and response.
Specifically, HHS is the lead agency for medical response; USDA for
veterinary response; State for international activities; and DHS for
overall domestic incident management, sustainment of critical
infrastructure and key resources, and federal coordination. The Plan also
briefly describes the preparedness and response roles and responsibilities
of DOD, the Department of Labor, DOT, and Treasury. The Plan states that
these and all federal cabinet agencies are responsible for their
respective sectors and developing pandemic response plans. In addition,
the Strategy and Plan broadly describe the expected roles and
responsibilities of state, local, and tribal governments; international
partners; the private and nonprofit sectors; and individuals and families.
For example, in the functional area of transportation and borders, the
Plan states that it expects state and local communities to involve
transportation and health professionals to identify transportation
options, consequences, and implications in the event of a pandemic.
The Plan states that the primary mechanism for coordinating the federal
government's response to a pandemic is the NRP. In this regard, the Plan
acknowledges that sustaining mechanisms for several months to over a year
will present unique challenges, and thus day-to-day monitoring of the
response to a pandemic influenza would occur through the national
operations center with an interagency body composed of senior decision
makers from across the government and chaired by the White House.
Additionally, the Plan states that policy issues that cannot be resolved
at the department level would be addressed through the HSC-National
Security Council policy coordination process. As stipulated in the Plan,
the specifics of this policy coordination mechanism were included in the
May 2006 revisions to the NRP.
The Plan also generally identifies lead and support roles for the action
items federal agencies are responsible for completing, but it is not
explicit in defining these roles or processes for coordination and
collaboration. While it identifies which federal agencies have lead and
support roles for completing 305 action items, the Plan does not define
the roles of the lead and support agencies. Rather, it leaves it to the
agencies to interpret and negotiate their roles. According to DOT
officials we met with, this lack of clarity, coupled with staff turnover,
left them unclear about their roles and responsibilities in completing
action items. Thus, they had to seek clarification from DHS and HHS
officials to assist them in defining what it meant to be the lead agency
for an action item. Additionally, the Plan does not describe specific
processes for coordination and collaboration between federal and
nonfederal organizations and sectors for completing the action items.
Related to this issue, we recently reported that some of DOD's combatant
commands, tasked with providing support in the event of a pandemic, had
received limited detailed guidance from the lead agencies about what
support they may be asked to provide during a pandemic.^31 This has
hindered these commands' ability to plan to provide support to lead
federal agencies domestically and abroad during a pandemic.
The Plan also does not describe the role played by organizations that are
to provide the overall framework for accountability and oversight, such as
the HSC. According to agency officials, the HSC is monitoring executive
branch agencies' efforts to complete the action items. However, there is
no specific documentation describing this process or institutionalizing
it. This is important since some of the action items are not expected to
be completed during this administration. Also, a similar oversight process
for those actions items for which nonfederal entities have the lead
responsibility does not appear to exist.
The Strategy and Plan Partially Address Integration and Implementation
A national strategy should make clear how it relates to the goals,
objectives, and activities of other strategies and to subordinate levels
of government and their plans to implement the strategy. A strategy might
also discuss, as appropriate, various strategies and plans produced by
state, local, private, and international sectors. A clear relationship
between the strategy and other critical implementing documents helps
agencies and other entities understand their roles and responsibilities,
foster effective implementation, and promote accountability. We found that
the Strategy and Plan partially address this characteristic. Although the
documents mention other related national strategies and plans, they do not
provide sufficient detail describing the relationships among these
strategies and plans nor do they describe how subordinate levels of
government and independent plans proposed by the Plan would be integrated
to implement the Strategy.
^31 GAO, Influenza Pandemic: DOD Combatant Commands' Preparedness Efforts
Could Benefit from More Clearly Defined Roles, Resources, and Risk
Mitigation, [40]GAO-07-696 (Washington, D.C.: June 20, 2007).
Since September 11, 2001, various national strategies, presidential
directives, and national initiatives have been developed to better prepare
the nation to respond to incidents of national significance, such as a
pandemic influenza. As noted in figure 2, these include the National
Security Strategy and the NRP. However, although the Strategy states that
it is consistent with the National Security Strategy and the National
Strategy for Homeland Security, it does not state how it is consistent or
describe its relationship with these two strategies. In addition, the Plan
does not specifically address how the Strategy or other related pandemic
plans should be integrated with the goals, objectives, and activities of
the national initiatives already in place.
Figure 2: Related National Preparedness Strategies, Initiatives, and Plans
Whereas the Plan states that it supports Homeland Security Presidential
Directive 8, which required the development of a domestic all-hazards
preparedness goal--the National Preparedness Goal (Goal)--it does not
describe how it supports the directive or its relationship to the Goal.^32
The current interim Goal is particularly important for determining what
capabilities are needed for a catastrophic disaster. It defines 36 major
capabilities that first responders should possess to prevent, protect
from, respond to, and recover from a wide range of incidents and the most
critical tasks associated with these capabilities. An inability to
effectively perform these critical tasks would, by definition, have a
detrimental effect on protection, prevention, response, and recovery
capabilities. The interim Goal also includes 15 planning scenarios,
including one for pandemic influenza that outlines universal and critical
tasks to be undertaken for planning for an influenza pandemic and target
capabilities, such as search and rescue and economic and community
recovery. Yet, the Strategy and Plan do not integrate this
already-developed planning scenario and related tasks and capabilities.
One federal agency official who assisted in drafting the Plan told us that
the Goal and its pandemic influenza scenario had been considered but
omitted because the Goal's pandemic influenza scenario is geared to a less
severe pandemic--such as those that occurred in 1957 and 1968--while the
Plan is based on the more severe 1918-level mortality and morbidity rates.
Further, the Strategy and Plan do not provide sufficient detail about how
the Strategy, action items, and proposed set of independent plans are to
be integrated with other national strategies and framework. Without
clearly providing this linkage, the Plan may limit a common understanding
of the overarching framework, thereby hindering the nation's ability to
effectively prepare for, respond to, and recover from a pandemic. For
example, the Plan contains 39 action items that are response related
(i.e., specific actions are to be taken within a prescribed number of
hours or days after an outbreak). However, these action items are
interspersed among the 324 action items, and the Plan does not describe
the linkages of these response-related action items with the NRP or other
response related plans. Further, DHS officials have recognized the need
for a common understanding across federal agencies and better integration
of agencies plans to prepare for and respond to a pandemic. DHS officials
are developing a Federal Concept Plan for Pandemic Influenza to enhance
interagency preparedness, response, and recovery efforts.
^32 The Goal establishes the national vision and priorities to guide the
nation's efforts to set measurable readiness benchmarks and targets to
strengthen the nation's preparedness, and attempts to provide a
comprehensive preparedness effort.
The Plan also requires the federal departments and agencies to develop
their own pandemic plans that describe the operational details related to
the respective action items and cover the following areas: (1) protection
of their employees; (2) maintenance of their essential functions and
services; (3) how they would support both the federal response to a
pandemic and those of states, localities, and tribal entities; and (4) the
manner in which they would communicate messages about pandemic planning
and response to their stakeholders. Further, it is unclear whether all the
departments will share some or all of the information in their plans with
nonfederal entities. While some agencies-such as HHS, DOD, and the
Department of Veterans Affairs-have publicly released their pandemic
plans, at least one agency, DHS, has indicated that it does not intend to
publicly release its plan. Since DHS is a lead agency for planning for and
responding to a pandemic, this gap may make it more challenging to fully
advance joint and integrated planning across all levels of government and
the private sector.
The Plan recognizes and discusses the need for integrating planning across
all levels of government and the private sector to ensure that the plans
and response actions are complementary, compatible, and coordinated. In
this regard, the Plan provides initial planning guidance for state, local,
and tribal entities; businesses; schools and universities; and
nongovernmental organizations for a pandemic. It also includes various
action items that when completed, would produce additional planning
guidance and materials for these entities. However, the Plan is unclear as
to how the existing guidance relates to broad federal and specific
departmental and agency plans as well as how the additional guidance would
be integrated and how any gaps or conflicts that exist would be identified
and addressed.
Conclusions
Although it is likely that an influenza pandemic will occur in the future,
there is a high level of uncertainty about when a pandemic might occur and
its level of severity. The administration has taken an active approach to
this potential disaster by establishing an information clearinghouse for
pandemic information; developing numerous planning guidelines for
governments, businesses, nongovernmental organizations, and individuals;
issuing the Strategy and Plan; completing many action items contained in
the Plan; and continuing efforts to complete the remaining action items.
A pandemic poses some unique challenges. Other disasters, such as
hurricanes, earthquakes, or terrorist attacks, generally occur within a
short period and the immediate effects are experienced in specific
locations. By contrast, a pandemic would likely occur in multiple waves,
each lasting weeks or months and affecting communities across the nation.
Initial actions may help limit the spread of an influenza virus,
reflecting the importance of a swift and effective response. Therefore,
the effective exercise of shared leadership roles and responsibilities
could have substantial consequences, both in the short and long term.
However, these roles and responsibilities continue to evolve, leaving
uncertainty about how the federal government would lead preparations for
and response to a pandemic. Since the release of the Plan in May 2006, no
national pandemic exercises of federal leadership roles and
responsibilities have been conducted. Without rigorous testing, training,
and exercising, the administration lacks information to determine whether
current and evolving leadership roles and responsibilities are clear and
clearly understood or if more changes are needed to ensure clarity.
The Strategy and Plan are important because they broadly describe the
federal government's approach and planned actions to prepare for and
respond to a pandemic, as well as expectations for states and communities,
the private sector, and global partners. Although they contain a number of
important characteristics, the documents lack several key elements. As a
result, their usefulness as a management tool for ensuring accountability
and achieving results is limited. For example, because the Strategy and
Plan do not address the resources and investments needed to implement the
actions called for, it is unclear what resources are needed to build
capacity and whether they would be available. Further, because they did
not include stakeholders that are expected to be the primary responders to
a pandemic in the development of the Strategy and Plan, these documents
may not fully reflect a national perspective on this critical national
issue, and stakeholders and the public may not have a full understanding
of their critical roles. In addition, the linkages among pandemic planning
efforts and with all-hazards plans and initiatives need to be clear so
that the numerous parties involved can operate in an integrated manner.
Finally, because many of the performance measures do not provide
information about the impacts of proposed actions, it will be difficult to
assess the extent to which we are better prepared or to identify areas
needing additional attention. Opportunities exist to improve the
usefulness of the Plan because it is viewed as an evolving document and is
intended to be updated on a regular basis to reflect ongoing policy
decisions, as well as improvements in domestic preparedness. Currently,
however, time frames or mechanisms for updating the Plan are undefined.
While the HSC publicly reported on the status of approximately 100 action
items that were to have been completed by November 2006, the Plan lacks a
prescribed process for monitoring and reporting on the progress of the
action items or what has been accomplished as a result. Therefore, it is
unclear when the next report will be issued or how much information will
be released. In addition, some of the information reported was incorrect.
This lack of transparency makes it difficult to inform a national dialogue
on the progress made to date or what further steps are needed. It also
inhibits congressional oversight of strategies, funding priorities, and
critical efforts to enhance the nation's level of preparedness.
DHS officials believe that their efforts to develop a Federal Concept Plan
for Pandemic Influenza may help to more fully address some of the
characteristics that we found the Strategy and Plan lack. According to
those officials, the proposed Concept Plan may help, for example, better
integrate the organizational roles, responsibilities, and coordination of
interagency partners. They recognized, however, that the Concept Plan
would not fully address all of the gaps we have identified. For example,
they told us that the Concept Plan may not address actual or estimated
costs or investments of the resources that will be required. Overall, they
agreed that more needs to be done, especially in view of the long time
requirements and challenging issues presented by a potential pandemic
influenza.
Recommendations for Executive Action
To enhance preparedness efforts for a possible pandemic, we are making the
following two recommendations:
We recommend that the Secretaries of Homeland Security and Health and
Human Services work together to develop and conduct rigorous testing,
training, and exercises for pandemic influenza to ensure that 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.
We also recommend that the Homeland Security Council establish a specific
process and time frame for updating the Implementation Plan for the
National Strategy for Pandemic Influenza. The process for updating the
Plan should involve key nonfederal stakeholders and incorporate lessons
learned from exercises and other sources. The Plan should also be improved
by including the following information in the next update:
o the cost, sources, and types of resources and investments needed
to complete the action items and where they should be targeted;
o a process and schedule for monitoring and publicly reporting on
progress made on completing the actions;
o clearer linkages with other strategies and plans; and
o clearer descriptions of relationships or priorities among action
items and greater use of outcome-focused performance measures.
Agency Comments and Our Evaluation
We provided a draft of this report to DHS, HHS, and the HSC for
review and comment. DHS provided written comments, which are
reprinted in appendix II. In commenting on the draft report, DHS
concurred with the first recommendation and stated that DHS is
taking action on many of the shortfalls identified in the report.
For example, DHS stated that it is working closely with HHS and
other interagency partners to develop and implement a series of
coordinated interagency pandemic exercises and will include all
levels of government as well as the international community and
the private and nonprofit sectors. Additionally, DHS stated that
its Incident Management Planning Team intends to use our list of
desirable characteristics of an effective national strategy as one
of the review metrics for all future plans. DHS also provided us
with technical comments, which we incorporated in the report as
appropriate.
HHS informed us that it had no comments and concurred with the
draft report. The HSC did not comment on the draft report.
As agreed with your offices, unless you publicly announce the
contents of this report earlier, we plan no further distribution
of it until 30 days from its date. We will then send copies of
this report to the appropriate congressional committees and to the
Assistant to the President for Homeland Security; the Secretaries
of HHS, DHS, USDA, DOD, State, and DOT; and other interested
parties. We will also make copies available to others upon
request. In addition, this report will be available at no charge
on the GAO Web site at http:/www.gao.gov.
If you or your staff have any questions regarding this report,
please contact me at (202) 512-6543 or [41][email protected] .
Contact points for our Offices of Congressional Relations and
Public Affairs may be found on the last page of this report. GAO
staff who made major contributions to this report are listed in
appendix III.
Bernice Steinhardt
Director
Strategic Issues
Appendix I: Scope and Methodology
Our reporting objectives were to review the extent to which (1)
federal leadership roles and responsibilities for preparing for
and responding to a pandemic are clearly defined and (2) the
National Strategy for Pandemic Influenza (Strategy) and the
Implementation Plan for the National Strategy for Pandemic
Influenza (Plan) address the characteristics of an effective
national strategy.
To determine to what extent federal leadership roles and
responsibilities for preparing for and responding to a pandemic
are clearly defined, we drew upon our extensive body of work on
the federal government's response to hurricanes Katrina and Rita
as well as our prior work on pandemic influenza. We also studied
the findings in reports issued by Congress, the Department of
Homeland Security's Office of the Inspector General, the Homeland
Security Council (HSC), and the Congressional Research Service.
Additionally, we reviewed the Strategy and Plan and a variety of
federal emergency documents, including the National Response
Plan's base plan and supporting annexes and the implementation
plans developed by the Departments of Homeland Security and Health
and Human Services. HSC officials declined to meet with us,
stating that we should rely upon information provided by agency
officials. We interviewed officials in the departments of
Agriculture, Defense, Health and Human Services, Homeland
Security, Transportation, and State and the Federal Emergency
Management Agency and the U.S. Coast Guard. Some of these
officials were involved in the development of the Plan.
To review the extent to which the Strategy and Plan address the
characteristics of an effective national strategy, we analyzed the
Strategy and Plan; reviewed key relevant sections of major
statutes, regulations, directives, national strategies, and plans
discussed in the Plan; and interviewed officials in agencies that
the Strategy and Plan identified as lead agencies in preparing for
and responding to a pandemic.
We assessed the extent to which the Strategy and Plan jointly
addressed the six desirable characteristics, and the related
elements under each characteristic, of an effective national
strategy by using the six characteristics developed in previous
GAO work.^1 Table 4 provides the desirable characteristics and
examples of their elements.
^1 [42]GAO-04-408T .
Table 4: GAO Desirable Characteristics for a National Strategy
Desirable
characteristic Brief description Examples of elements
Purpose, scope, and Addresses why the o Statement of broad or
methodology strategy was produced, narrow purpose, as
the scope of its appropriate.
coverage, and the o How it compares and
process by which it was contrasts with other
developed. national strategies.
o What major functions,
mission areas, or
activities it covers.
o Principles or
theories that guided
its development.
o Impetus for strategy,
for example, statutory
requirement or event.
o Process to produce
strategy, for example,
interagency task force
or state, local, or
private input.
o Definition of key
terms.
Problem definition and Addresses the particular o Discussion or
risk assessment national problems and definition of problems,
threats the strategy is their causes, and
directed toward. operating environment.
o Risk assessment,
including an analysis
of threats and
vulnerabilities.
o Quality of data
available, for example,
constraints,
deficiencies, and
"unknowns."
Goals, subordinate Addresses what the o Overall results
objectives, strategy is trying to desired, that is, "end
activities, and achieve; steps to state."
performance measures achieve those results; o Hierarchy of
as well as the strategic goals and
priorities, milestones, subordinate objectives.
and performance measures o Specific activities
to gauge results. to achieve results.
o Priorities,
milestones, and
outcome-related
performance measures.
o Specific performance
measures.
o Process for
monitoring and
reporting on progress.
o Limitations on
progress indicators.
Resources, Addresses what the o Resources and
investments, and risk strategy will cost, the investments associated
management sources and types of with the strategy.
resources and o Types of resources
investments needed, and required, such as
where resources and budgetary, human
investments should be capital, information
targeted by balancing technology, research
risk reductions and and development, and
costs. contracts.
o Sources of resources,
for example, federal,
state, local, and
private.
o Economic principles,
such as balancing
benefits and costs.
o Resource allocation
mechanisms, such as
grants, in-kind
services, loans, or
user fees.
o "Tools of
government," for
example, mandates or
incentives to spur
action.
o Importance of fiscal
discipline.
o Linkage to other
resource documents, for
example, federal
budget.
o Risk management
principles.
Organizational roles, Addresses who will be o Roles and
responsibilities, and implementing the responsibilities of
coordination strategy, what their specific federal
roles will be compared agencies, departments,
to others, and or offices.
mechanisms for them to o Roles and
coordinate their responsibilities of
efforts. state, local, private,
and international
sectors.
o Lead, support, and
partner roles and
responsibilities.
o Accountability and
oversight framework.
o Potential changes to
current organizational
structure.
o Specific processes
for coordination and
collaboration.
o How conflicts will be
resolved.
Integration and Addresses how a national o Integration with
implementation strategy relates to other national
other strategies' goals, strategies
objectives, and (horizontal).
activities--and to o Integration with
subordinate levels of relevant documents from
government and their implementing
plans to implement the organizations
strategy. (vertical).
o Details on specific
federal, state, local,
or private strategies
and plans.
o Implementation
guidance.
o Details on
subordinate strategies
and plans for
implementation, for
example, human capital
and enterprise
architecture.
Source: GAO.
National strategies with these characteristics offer policymakers and
implementing agencies a management tool that can help ensure
accountability and more effective results. We have used this methodology
to assess and report on the administration's strategies relating to
terrorism, rebuilding of Iraq, and financial literacy.^2
To assess whether the documents addressed these desirable characteristics,
two analysts independently assessed both documents against each of the
elements of a characteristic. If the analysts did not agree, a third party
reviewed, discussed, and made the final determination to rate that
element. Each characteristic was given a rating of either "addresses,"
"partially addresses," or "does not address." According to our
methodology, a strategy "addresses" a characteristic when it explicitly
cites all, or nearly all, elements of the characteristic and has
sufficient specificity and detail. A strategy "partially addresses" a
characteristic when it explicitly cites one or a few of the elements of a
characteristic and has sufficient specificity and detail. It should be
noted that the "partially addresses" category includes a range that varies
from explicitly citing most of the elements to citing as few as one of the
elements of a characteristic. A strategy "does not address" a
characteristic when it does not explicitly cite or discuss any elements of
a characteristic, any references are either too vague or general to be
useful, or both.
^2 [43]GAO-04-408T , [44]GAO-06-788 , and [45]GAO-07-100 .
We reviewed relevant sections of major statutes, regulations, directives,
and plans discussed in the Plan to better understand if and how they were
related. Specifically, our review included Homeland Security Presidential
Directive 5 on the Management of Domestic Incidents; the National Response
Plan; and the Robert T. Stafford Disaster Relief and Emergency Assistance
Act of 1974 (as amended) as well as other national strategies.
We conducted our review from May 2006 through June 2007 in accordance with
generally accepted government auditing standards.
Appendix II: Comments from the Department of Homeland Security
Appendix III: GAO Contact and Staff Acknowledgments
GAO Contact
Bernice Steinhardt, (202) 512-6543 or [46][email protected]
Acknowledgments
In addition to the contact named above, Susan Ragland, Assistant Director;
Allen Lomax; David Dornisch; Donna Miller; Catherine Myrick; and members
of GAO's Pandemic Working Group made key contributions to this report.
Related GAO Products
Homeland Security: Observations on DHS and FEMA Efforts to Prepare for and
Respond to Major and Catastrophic Disasters and Address Related
Recommendations and Legislation. [47]GAO-07-1142T . Washington, D.C.: July
31, 2007.
Emergency Management Assistance Compact: Enhancing EMAC's Collaborative
and Administrative Capacity Should Improve National Disaster Response.
[48]GAO-07-854 . Washington, D.C.: June 29, 2007.
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Benefit from More Clearly Defined Roles, Resources, and Risk Mitigation.
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[55]GAO-07-395T . Washington, D.C.: March 9, 2007.
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Accountability, Funding, and Communications Need to be Clearer and Focused
Departmentwide. [56]GAO-06-1042 . Washington, D.C.: September 21, 2006.
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during Disruptions. [58]GAO-06-740T . Washington, D.C.: May 11, 2006.
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with Major Emergency Incidents. [60]GAO-06-467T . Washington, D.C.:
February 23, 2006.
Statement by Comptroller General David M. Walker on GAO's Preliminary
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[66]GAO-05-177T . Washington, D.C.: November 18, 2004.
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Surveillance Efforts. [67]GAO-04-877 . Washington, D.C.: September 30,
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[78]GAO-01-4 . Washington, D.C.: October 27, 2000.
Global Health: Framework for Infectious Disease Surveillance.
[79]GAO/NSIAD-00-205R . Washington, D.C.: July 20, 2000.
(450450)
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[86]www.gao.gov/cgi-bin/getrpt?GAO-07-781 .
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Highlights of [87]GAO-07-781 , a report to congressional requesters
August 2007
INFLUENZA PANDEMIC
Further Efforts Are Needed to Ensure Clearer Federal Leadership Roles and
an Effective National Strategy
An influenza pandemic is a real and significant potential threat facing
the United States and the world. Pandemics occur when a novel virus
emerges that can easily be transmitted among humans who have little
immunity. In 2005, the Homeland Security Council (HSC) issued a National
Strategy for Pandemic Influenza and, in 2006, an Implementation Plan.
Congress and others are concerned about the federal government's
preparedness to lead a response to an influenza pandemic. This report
assesses how clearly federal leadership roles and responsibilities are
defined and the extent to which the Strategy and Plan address six
characteristics of an effective national strategy. To do this, GAO
analyzed key emergency and pandemic-specific plans, interviewed agency
officials, and compared the Strategy and Plan with the six characteristics
GAO identified.
[88]What GAO Recommends
GAO recommends that (1) DHS and HHS develop rigorous testing, training,
and exercises for pandemic influenza to ensure that federal leadership
roles and responsibilities are clearly defined, understood, and work
effectively and (2) the HSC set a time frame to update the Plan, involve
key nonfederal stakeholders, and more fully address the characteristics of
an effective national strategy. DHS and HHS concurred with the report. HSC
did not comment.
The executive branch has taken an active approach to help address this
potential threat, including establishing an online information
clearinghouse, developing planning guidance and checklists, awarding
grants to accelerate development and production of new technologies for
influenza vaccines within the United States, and assisting state and local
government pandemic planning efforts. However, federal government
leadership roles and responsibilities for preparing for and responding to
a pandemic continue to evolve, and will require further clarification and
testing before the relationships of the many leadership positions are well
understood. The Strategy and Plan do not specify how the leadership roles
and responsibilities will work in addressing the unique characteristics of
an influenza pandemic, which could occur simultaneously in multiple
locations and over a long period. A pandemic could extend well beyond
health and medical boundaries, affecting critical infrastructure, the
movement of goods and services across the nation and the globe, the
economy, and security. Although the Department of Health and Human
Services' (HHS) Secretary is to lead the public health and medical
response and the Department of Homeland Security's (DHS) Secretary is to
lead overall nonmedical support and response actions, the Plan does not
clearly address these simultaneous responsibilities or how these roles are
to work together, particularly over an extended period and at multiple
locations across the country. In addition, the Secretary of DHS has
predesignated a national Principal Federal Official (PFO) to facilitate
pandemic coordination as well as five regional PFOs and five regional
Federal Coordinating Officers. Most of these leadership roles and
responsibilities have not been tested under pandemic scenarios, leaving it
unclear how they will work. Because initial actions may help limit the
spread of an influenza virus, the effective exercise of shared leadership
roles and responsibilities could have substantial consequences. However,
only one national multisector pandemic-related exercise has been held and
that was prior to the issuance of the Plan.
While the Strategy and Plan are an important first step in guiding
national preparedness, they do not fully address all six characteristics
of an effective national strategy. Specifically, they fully address only
one of the six characteristics, by reflecting a clear description and
understanding of problems to be addressed, and do not address one
characteristic because the documents do not describe the financial
resources needed to implement actions. Although the other characteristics
are partially addressed, important gaps exist that could hinder the
ability of key stakeholders to effectively execute their responsibilities,
including state and local jurisdictions that will play crucial roles in
preparing for and responding to a pandemic were not directly involved in
developing the Plan, relationships and priorities among actions were not
clearly described, performance measures focused on activities that are not
always linked to results, insufficient information is provided about how
the documents are integrated with other key related plans, and no process
is provided for monitoring and reporting on progress.
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