[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
BEYOND THE CHECKLIST: ADDRESSING
SHORTFALLS IN NATIONAL PANDEMIC
INFLUENZA PREPAREDNESS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON EMERGING
THREATS, CYBERSECURITY AND
SCIENCE AND TECHNOLOGY
of the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 26, 2007
__________
Serial No. 110-72
__________
Printed for the use of the Committee on Homeland Security
[GRAPHIC] [TIFF OMITTED] TONGRESS.#13
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
__________
U.S. GOVERNMENT PRINTING OFFICE
48-967 WASHINGTON : 2009
-----------------------------------------------------------------------
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800
Fax: (202) 512�092104 Mail: Stop IDCC, Washington, DC 20402�0900012009
COMMITTEE ON HOMELAND SECURITY
BENNIE G. THOMPSON, Mississippi, Chairman
LORETTA SANCHEZ, California, PETER T. KING, New York
EDWARD J. MARKEY, Massachusetts LAMAR SMITH, Texas
NORMAN D. DICKS, Washington CHRISTOPHER SHAYS, Connecticut
JANE HARMAN, California MARK E. SOUDER, Indiana
PETER A. DeFAZIO, Oregon TOM DAVIS, Virginia
NITA M. LOWEY, New York DANIEL E. LUNGREN, California
ELEANOR HOLMES NORTON, District of MIKE ROGERS, Alabama
Columbia BOBBY JINDAL, Louisiana
ZOE LOFGREN, California DAVID G. REICHERT, Washington
SHEILA JACKSON LEE, Texas MICHAEL T. McCAUL, Texas
DONNA M. CHRISTENSEN, U.S. Virgin CHARLES W. DENT, Pennsylvania
Islands GINNY BROWN-WAITE, Florida
BOB ETHERIDGE, North Carolina MARSHA BLACKBURN, Tennessee
JAMES R. LANGEVIN, Rhode Island GUS M. BILIRAKIS, Florida
HENRY CUELLAR, Texas DAVID DAVIS, Tennessee
CHRISTOPHER P. CARNEY, Pennsylvania
YVETTE D. CLARKE, New York
AL GREEN, Texas
ED PERLMUTTER, Colorado
VACANCY
Rosaline Cohen, Staff Director & General Counsel
Rosaline Cohen, Chief Counsel
Michael Twinchek, Chief Clerk
Robert O'Connor, Minority Staff Director
______
SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND SCIENCE AND
TECHNOLOGY
JAMES R. LANGEVIN, Rhode Island, Chairman
ZOE LOFGREN, California MICHAEL T. McCAUL, Texas
DONNA M. CHRISTENSEN, U.S. Virgin DANIEL E. LUNGREN, California
Islands GINNY BROWN-WAITE, Florida
BOB ETHERIDGE, North Carolina MARSHA BLACKBURN, Tennessee
AL GREEN, Texas PETER T. KING, New York (Ex
VACANCY Officio)
BENNIE G. THOMPSON, Mississippi (Ex
Officio)
Jacob Olcott, Director & Counsel
Dr. Chris Beck, Senior Advisor for Science & Technology
Carla Zamudio-Dolan, Clerk
Dr. Diane Berry, Minority Senior Professional Staff Member
(II)
C O N T E N T S
----------
Page
STATEMENTS
The Honorable James R. Langevin, a Representative in Congress
From the State of Rhode Island, Chairman, Subcommittee on
Emerging Threats, Cybersecurity, and Science and Technology:
Oral Statement................................................. 1
Prepared Statement............................................. 3
The Honorable Michael T. McCaul, a Representative in Congress
From the State of Texas, Ranking Member, Subcommittee on
Emerging Threats, Cybersecurity, and Science and Technology.... 4
The Honorable Bill Pascrell, Jr., a Representative in Congress
From the State of New Jersey................................... 31
WITNESSES
Panel I
B. Tilman Jolly, MD, Associate Chief Medical Officer for Medical
Readiness, Office of Health Affairs, Department of Homeland
Security:
Oral Statement................................................. 13
Prepared Statement............................................. 15
Ms. Bernice Steinhardt, Director, Strategic Issues, Government
Accountability Office:
Oral Statement................................................. 5
Prepared Statement............................................. 7
RADM W. Craig Vanderwagen, MD, Assistant Secretary for
Preparedness and Response, Department of Health and Human
Services:
Oral Statement................................................. 17
Prepared Statement............................................. 19
Panel II
L. Anthony Cirillo, MD, Center for Emergency Preparedness and
Response, Rhode Island Department of Health:
Oral Statement................................................. 37
Prepared Statement............................................. 39
Michael C. Caldwell, MD, MPH, Commissioner, Dutchess County
Health Department, Poughkeepsie, New York:
Oral Statement................................................. 49
Prepared Statement............................................. 51
Peter A. Shult, PhD, Director, Communicable Diseases Division,
Wisconsin State Laboratory of Hygiene:
Oral Statement................................................. 43
Prepared Statement............................................. 44
David L. Lakey, MD, Commissioner, Texas Department of State
Health Services, Center for Consumer and External Affairs:
Oral Statement................................................. 56
Preapred Statement............................................. 58
Appendexes
Appendix I.: Letter
David L. Lakey, MD............................................. 73
Appendix II.: Additional Questions and Responses
Responses from Michael C. Caldwell, MD, MPH.................... 75
Responses from L. Anthony Cirillo, MD.......................... 78
Responses from B. Tilman Jolly, MD............................. 82
Responses from David L. Lakey, MD.............................. 93
Responses from Peter A. Shult, PhD............................. 101
Responses from Ms. Bernice Steinhardt.......................... 106
Responses from W. Craig Vanderwagen, MD........................ 107
BEYOND THE CHECKLIST: ADDRESSING SHORTFALLS IN NATIONAL PANDEMIC
INFLUENZA PREPAREDNESS
----------
wednesday, September 26, 2007
U.S. House of Representatives,
Committee on Homeland Security,
Subcommittee on Emerging Threats, Cybersecurity
and Science and Technology,
Washington, DC.
The subcommittee met, pursuant to call, at 10:11 a.m., in
Room 311, Cannon House Office Building, Hon. James Langevin
[chairman of the subcommittee] presiding.
Present: Representatives Langevin, Pascrell, and McCaul.
Mr. Langevin. [Presiding.] The Committee on Homeland
Security will come to order. The committee is meeting today to
receive testimony on Beyond the Checklist: Addressing
Shortfalls in National Pandemic Influenza Preparedness.
Good morning. I would like to take this opportunity to
thank the witnesses on both our panels for apprearing today.
And I would especially like to thank and welcome Dr. Tony
Cirillo from my home state of Rhode Island, who will be
participating in the second panel this morning.
Let me just say I appreciate your willingness to help
Congress understand the devastating nature of pandemic
influenza and to work with us in determining what resources are
necessary to help prepare the nation before a pandemic occurs.
Today we will explore what it takes to prepare for and
respond to an influenza pandemic that would affect every sector
of society and every person in the world.
Planning is problematic to begin with because it is so
difficult to fathom both the potential casualties and the
impact of such a pandemic.
Even when we focus just on our own country, the projected
numbers are still staggering--200,000 dead, 2 million ill, all
sectors and every aspect of the infrastructure negatively
impacted.
Though this is a problem that we will not be able to
control through standard disease management practices, we can
and must rise to the challenge. Make no mistake about it--we
are due for a severe influenza pandemic at some point for a
variety of reasons.
The influenza viruses that could result in a pandemic are
increasing in virulence. Record numbers of humans are now
living in close proximity to current and potential animal
carriers.
Rapid transit moves people and cargo at increasingly faster
rates, fostering the movement and transfer of diseases.
Influenza viruses are already mutating faster than we could
have imagined, and the toll that avian influenza is taking on
other countries is already devastating.
The impact this disease could have on the security of our
homeland is indeed worrisome, which is why awareness and
preparedness are critical.
Increased emphasis on pandemic planning and preparedness
for the United States in recent years has resulted in the
generation of the National Strategy for Pandemic Influenza,
released in November 2005, and its Implementation Plan,
released in May 2006.
Some departments and agencies within the executive branch
have also created their own strategies to distribute resources
and guidance throughout the country at all levels of government
and to the private sector based on their strategies and the
National Strategy itself.
Although these are positive steps, one thing is clear. The
nation is still not ready for an influenza pandemic to occur
here or overseas.
Today we will discuss the insufficiencies of the National
Strategy and its Implementation Plan and hopefully find ways to
improve upon our current strategies.
The Implementation Plan for the National Strategy is
composed of hundreds of separate actions forming a checklist
with some 324 items.
Although checklists are good tools for getting things
accomplished, we can sometimes make checking things off more
important than actually achieving the goals and objectives we
set out for ourselves in the first place.
Our nation's leaders are not seeing the big picture.
Instead, they are driving our departments and agencies to focus
so much effort on checking boxes that there is barely time left
to actually combat a potential pandemic.
We need to address the shortfalls in our national pandemic
influenza preparedness and get beyond the checklist.
Our effort seems to have gotten stuck at the federal level
but it is time to shift our resources to the states,
territories, tribes and localities.
State, territorial, tribal and local entities have found
themselves preparing for a pandemic without adequate funding,
necessary resources, strategy-driven guidance or strong
leadership.
When pandemic influenza hits this country, our public
health professionals and health care practitioners will be
fighting to save lives and the federal government will be
assisting in those efforts. We need to cater to them, not the
checklist.
Today we will also examine the interactions among the
members of the executive branch, especially the Department of
Homeland Security and the Department of Health and Human
Services as they co-lead activities to manage an influenza
pandemic when it does strike our nation.
Unfortunately, there is little evidence that either agency
knows what their roles and responsibilities would be during an
actual event.
And I very much fear another Hurricane Katrina situation,
where delays in identifying principal federal officials
resulted in a significant problem and unnecessary losses of
life. We cannot afford for this to ever happen again.
We must therefore work the uncertainties out today so that
we can properly deal with these situations tomorrow. I very
much appreciate the efforts put forward by our federal and non-
federal colleagues in the private and public sectors, and thank
you all for being here this morning.
With that, the chair now recognizes the ranking member of
the subcommittee, the gentleman from Texas, Mr. McCaul, for the
purpose of an opening statement.
Prepared Opening Statement of the Honorable James R. Langevin,
Chairman, Subcommittee on Emerging Threats, Cybersecurity, and Science
and Technology
Good morning, I'd like to thank the witnesses on both of our panels
for appearing today, and I would especially like to thank Dr. Tony
Cirillo from my home state of Rhode Island who will be participating on
the second panel. I appreciate your willingness to help Congress
understand the devastating nature of pandemic influenza--and to work
with us in determining what resources are necessary to help prepare the
Nation before a pandemic occurs.
Today we will explore what it takes to prepare for, and respond to,
an influenza pandemic that would affect every sector of society, and
every person in the world. Planning is problematic to begin with,
because it is so difficult to fathom both the potential casualties and
the impact of such a pandemic. Even when we focus just on our own
country, the projected numbers are still staggering--200,000 dead, 2
million ill, all sectors and every aspect of the infrastructure
negatively impacted. Though this is a problem that we will not be able
to control through standard disease management practices, we can and
must rise to the challenge. Make no mistake about it, we are due for a
severe influenza pandemic.
The influenza viruses that could result in a pandemic are
increasing in virulence. Record numbers of humans are now living in
proximity to current and potential animal carriers. Rapid transit moves
people and cargo at increasingly faster rates, fostering the movement
and transfer of diseases. Influenza viruses are already mutating faster
than we could have imagined, and the toll that avian influenza is
taking on other countries is already devastating.
The impact this disease could have on the security of our homeland
is indeed worrisome, which is why awareness and preparedness is
critical. Increased emphasis on pandemic planning and preparedness for
the United States in recent years has resulted in the generation of the
National Strategy for Pandemic Influenza (released in November 2005)
and its Implementation Plan (released in May 2006). Some Departments
and agencies within the Executive Branch have also created their own
strategies, and distributed resources and guidance throughout the
country, at all levels of government, and to the private sector--based
on their strategies and the National Strategy itself. Although these
are positive steps, one thing is clear: the Nation is still not ready
for an influenza pandemic to occur here or overseas.
Today we will discuss the insufficiencies in the National Strategy
and its Implementation Plan, and hopefully find ways to improve upon
our current strategies. The Implementation Plan for the National
Strategy is composed of hundreds of separate actions--forming a
checklist with 324 items. Although checklists are good tools for
getting things accomplished, we can sometimes make checking things off
more important than actually achieving the goals and objectives we set
for ourselves in the first place.
Our Nation's leaders are not seeing the big picture--instead, they
are driving our Departments and agencies to focus so much effort on
checking boxes that there is barely time left to actually combat a
potential pandemic. We need to address the shortfalls in our National
Pandemic Influenza Preparedness, and get beyond the checklist. Our
efforts States, Territories, Tribes, and Localities. State,
territorial, tribal, and local entities have found themselves preparing
for a pandemic without:
` Adequat funding,
` Necessary resource,
` Strategy-driven guidance, or
` Strong leadership.
When pandemic influenza hits this country, our public health
professionals and health care practitioners will be fighting to save
lives, and the Federal government will be assisting in those efforts.
We need to cater to them, not the checklist. Today we'll also examine
the interactions among the members of the Executive branch--especially
the Department of Homeland Security and the Department of Health and
Human Service as they co-lead activities to manage an influenza
pandemic when it does strike our nation.
Unfortunately, there is little evidence that either agency knows
what their roles and responsibilities would be during an event. I very
much fear another Hurricane Katrina situation, where delays in
identifying principal federal officials resulted in the significant
problems and unnecessary losses of life. We cannot afford for this to
happen again. We must therefore work the uncertainties out today so we
can properly deal with these situations tomorrow. I very much
appreciate the efforts put forward by our Federal and non-federal
colleagues, in the private and public sectors, and thank you for being
here this morning.
Mr. McCaul. I thank the chairman.
I would like to welcome our distinguished panel of
witnesses here today, and in particular Dr. David Lakey from my
home town of Austin, Texas, who will be on the second panel
here today.
In the 109th Congress this committee held hearings and a
series of briefings which examined the National Strategy for
Pandemic Influenza and its Implementation Plan.
Today we are more than a year after the Implementation Plan
was released, and we ask whether we are more prepared today
than we were then to deal with the potential onset of a
pandemic.
I hope the answer is yes, that we are more prepared. I
think the answer is yes, but there is certainly more to be
done.
Never before has the human population anticipated and
prepared for a pandemic. We cannot be certain that our efforts
are enough or if they are even realistic. But we do know that
we are long overdue for an outbreak of influenza.
The 20th century witnessed three separate pandemics that
cost hundreds of thousands of lives, and we understand that the
efforts we make now to prepare for a pandemic, whether it is
caused by the H5N1 strain or some other unidentified strain,
will shape the scope of that pandemic and may save countless
lives.
The release of the National Strategy and the Implementation
Plan were certainly, in my view, a step in the right direction.
I agree that pandemic preparedness efforts should go beyond
merely checking the box for the action items in the plan and
that a comprehensive and flexible approach should be adopted.
I don't want us to overlook the significant
accomplishments, however, that the federal government has made
in its efforts to plan for a pandemic. We are working with our
international partners to limit the spread of H5N1 overseas in
hopes that it will not reach the United States.
We are expanding our vaccine development capability and
stockpiling antiviral drugs which will be critical at the onset
of the pandemic.
Plans have been made to increase surge capacity at medical
facilities and to continue the operations of government and
private sector business during high rates of absenteeism.
But we must not be complacent. It is important that the
relevant players clarify and test their leadership roles and
responsibilities for a pandemic situation.
It is also important that others involved in the pandemic
planning process, including state and local governments,
understand their roles.
And while the media coverage of this issue has certainly
waned, the threat posed by the emergence of pandemic influenza
to homeland security has not.
I am happy to see that this committee is continuing its
examination of pandemic preparedness in this Congress.
And I want to thank you, Mr. Chairman, for holding this
hearing, and I yield back.
Mr. Langevin. I thank the gentleman.
This is obviously a very busy day on the Hill. We will have
members coming in and out and several markups going on.
But other members of the committee are reminded that under
committee rules, opening statements may be submitted for the
record.
And I now welcome the first panel of witnesses. Our first
witness, Ms. Bernice Steinhardt, is the Director of Strategic
Studies at the United States Government Accountability Office.
Our second witness is Dr. Tilman Jolly. Dr. Jolly is the
associate chief medical officer for medical readiness in the
Office of Health Affairs at the Department of Homeland
Security.
And our third witness is Dr. Craig Vanderwagen, Assistant
Secretary for Preparedness and Response at the Department of
Health and Human Services. Dr. Vanderwagen was the senior
federal health official in the response to Hurricane Katrina
and Rita.
We thank all three of our witnesses for their service to
the nation and for being here today. We look forward to your
testimony.
Without objection, the witnesses' full statements will be
inserted in the record.
And I now ask each witness to summarize his or her
statement for 5 minutes, beginning with Ms. Steinhardt.
Welcome.
STATEMENT OF BERNICE STEINHARDT, DIRECTOR, STATEGIC ISSUES,
GOVERNMENT ACCOUNTABILITY OFFICE
Ms. Steinhardt. Thank you very much, Mr. Chairman and Mr.
McCaul. We really appreciate the opportunity to be here today
to talk about our recent report on planning for potential
pandemic influenza in the United States.
Fortunately, the administration has taken an active
approach in preparing a national pandemic Strategy and
Implementation Plan. But we found that much more needs to be
done to make sure that federal leadership roles are clear and
that the plan is viable and can be effectively implemented.
Let me turn to leadership roles first. The plan assigns
shared leadership roles to the Secretaries of Health and Human
Services and Homeland Security, the first for medical response
in a pandemic and the DHS secretary for overall incident
management and response.
But given that a severe pandemic would entail not only a
medical response but would also have to focus on sustaining
critical infrastructure and the economy, it is not clear when
in a pandemic the HHS Secretary would have the lead and when
the DHS Secretary would have the lead.
And these two are far from the only leadership positions.
Under the Post-Katrina Reform Act, which was enacted subsequent
to the pandemic Strategy and Plan, the FEMA administrator has
now been designated the Principal Domestic Emergency Management
Advisor to the President.
And also after the pandemic Plan was prepared, the DHS
Secretary pre-designated a national Principal Federal Official,
or a PFO, and created five pandemic regions, each with a
regional PFO and a Federal Coordinating Officer, or FCO, all of
them responsible to some extent for coordinating federal
planning, exercise and support.
Not only is this leadership structure complex and
potentially confusing, it has never been tested.
As this committee well understands, as your remarks
indicated, Mr. Chairman, one of the major lessons the country
learned from Katrina was that plans and assumptions have to be
understood, they have to be tested and the lessons learned
incorporated into plans before emergencies occur.
Yet the only national pandemic exercise to date was a
Cabinet-level tabletop simulation in December 2005, well before
the national Implementation Plan was released and the
leadership structure created.
I want to turn now to our assessment of the national
pandemic Strategy and Plan. Although the Plan did a good job in
defining the problem and discussing constraints and challenges,
it is missing some significant elements. I want to highlight
just a few here.
For one thing, the plan does not identify what it will cost
to carry out. Obviously, our ability to do all that the plan
outlines is going to be affected by our ability to pay for it.
Not everything is going to be easily addressed through
existing mechanisms and could, in fact, place considerable
stress on existing resources.
We are also concerned that despite the fact that states,
local and tribal entities will be on the front lines of the
pandemic, these stakeholders were not directly involved in
developing the Strategy and Plan.
And lastly, we noted that there is no provision in the plan
for monitoring and reporting on progress and for updating the
plan to reflect lessons learned from exercises or changes in
leadership responsibilities or other policy decisions.
To address these gaps, we outline several steps. First, we
recommended that the HHS and DHS Secretaries work together to
develop and conduct rigorous testing, training and exercises
for pandemic influenza.
We also recommended that the Homeland Security Council
establish a specific process and time frame for updating the
plan, one that involves key non-federal stakeholders and fills
in other gaps that we identified.
I would note that HHS and DHS agreed with our
recommendations, but the Homeland Security Council did not
respond or offer comments on the report.
I want to say, in closing, that these gaps are not trivial
or simply procedural. When a pandemic actually occurs, the
effectiveness of actions that are taken at the outset are going
to be of critical importance in helping to limit the spread of
the disease.
While we recognize that our understanding of the virus is
still evolving, it is important to take these steps now before
a disaster strikes.
With that, I will conclude my remarks and I look forward to
your questions. Thank you.
[The statement of Ms. Steinhardt follows:]
Prepared Statement of Bernice Steinhardt
Mr. Chairman and Members of the Subcommittee:
I am pleased to appear here today to discuss the federal
government's efforts to prepare for and respond to a possible influenza
pandemic. An influenza pandemic is a real and significant threat facing
the United States and the world. Although the timing and severity of
the next pandemic is unpredictable, there is widespread agreement that
a pandemic will occur at some point. Unlike incidents that are
discretely bounded in space or time (such as a storm or a terrorist
attack), a pandemic is not a singular event, but is likely to come in
waves, each lasting weeks or months, and could pass through communities
of all sizes across the nation and the world simultaneously.
Today, I will discuss (1) federal leadership roles and
responsibilities for preparing for and responding to a pandemic, (2)
our assessment of the National Strategy for a Pandemic Influenza
(Strategy) and the Implementation Plan for the National Strategy for a
Pandemic Influenza (Plan), and (3) opportunities to increase the
clarity of federal leadership roles and responsibilities and improve
pandemic planning.
This statement is based on our August 14, 2007, report, requested
by the Ranking Member, Senate Budget Committee; the Chairman and
Ranking Member, House Committee on Oversight and Government Reform; and
the Chairman, House Committee on Homeland Security.\1\ Our objectives
in that report were 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; we conducted our work in accordance with generally accepted
government auditing standards. We analyzed relevant documents,
interviewed cognizant federal officials, and assessed the Strategy and
Plan to determine the extent to which they jointly addressed the six
desirable characteristics of an effective national strategy that we
developed and used in previous work.\2\ 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.
---------------------------------------------------------------------------
\1\ GAO, Influenza Pandemic: Further Efforts Are Needed to Ensure
Clearer Leadership Roles and an Effective National Strategy, GAO-07-781
(Washington, D.C.: Aug. 14, 2007).
\2\ See GAO, Combating Terrorism: Evaluation of Selected
Characteristics in National Strategies Related to Terrorism, GAO-04-
408T (Washington, D.C.: Feb. 3, 2004); Rebuilding Iraq: More
Comprehensive National Strategy Needed to Help Achieve U.S. Goals, GAO-
06-788 (Washington, D.C.: July 11, 2006); and Financial Literacy and
Education Commission: Further Progress Needed to Ensure an Effective
National Strategy, GAO-07-100 (Washington, D.C.: Dec. 4, 2006).
---------------------------------------------------------------------------
In summary, although the administration has taken an active
approach to this potential disaster by developing a Strategy and Plan,
and has undertaken a number of other efforts, much more needs to be
done to ensure that the Plan is more viable and can be effectively
implemented in the event of an influenza pandemic.
Key federal leadership roles and responsibilities for
preparing for and responding to a pandemic continue to evolve
and will require further clarification and testing before the
relationships of the many leadership positions are well
understood. Most of these leadership roles involve shared
responsibilities, and it is not clear how these would work in
practice. Because initial actions may help limit the spread of
an influenza virus, the effective exercise of shared leadership
roles and responsibilities could have substantial consequences.
However, only one national, multisector pandemic-related
exercise has been held, and that was prior to issuance of the
Plan.
The Strategy and Plan do not fully address the
characteristics of an effective national strategy and contain
gaps that could hinder the ability of key stakeholders to
effectively execute their responsibilities. In addition to the
fact that the Strategy and Plan do not clarify how responsible
officials will share leadership responsibilities, they do not
include a description of the resources required to implement
the Plan, and consequently do not provide a picture of
priorities or how adjustments might be made in view of resource
constraints. Additionally, 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, and
the linkage of the Strategy and Plan with other key plans is
unclear.
The gaps in the Strategy and Plan are particularly troubling
because they can affect the usefulness of these planning documents for
those with key roles to play and, with no mechanisms for future updates
or progress assessments, limit opportunities for congressional decision
makers and the public to assess the extent of progress being made or to
consider what areas or actions may need additional attention.
We made two recommendations in our August 2007 report to address
these concerns.
We recommended 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. 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 and responsibilities are clearly understood by
nonfederal partners.
Our report also recommended that the Homeland Security
Council (HSC) establish a specific process and time frame for
updating the Plan. This process should involve key nonfederal
stakeholders and incorporate lessons learned from exercises and
other sources. The next update of the Plan could be improved by
addressing the gaps we identified.
The Department of Health and Human Services (HHS) and the
Department of Homeland Security (DHS) concurred with the first
recommendation. The HSC did not comment on the draft report or our
recommendation.
Background
To address the potential threat of an influenza pandemic, the
President and his HSC issued two planning documents. The 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 Plan was issued in May 2006 and 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 and most of them are
to be completed before or by May 2009. It 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,
tribal entities, the private sector, global partners, and individuals.
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.
Federal Leadership Roles Are Unclear, Evolving, and Untested
Several federal leadership roles involve shared responsibilities
for preparing for and responding to an influenza pandemic, including
the Secretaries of Health and Human Services and Homeland Security, the
Administrator of the Federal Emergency Management Agency (FEMA), a
national Principal Federal Official (PFO), and regional PFOs and
Federal Coordinating Officers (FCO). Many 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.
Federal Leadership Roles and Responsibilities Are Unclear and Evolving
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
National Response Plan (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 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.
The Strategy and Plan state that the Secretary of Health and Human
Services is 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.
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. 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. 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.
Moreover, under the Post-Katrina Emergency Management Reform Act of
2006 (referred to as the Post-Katrina Reform Act in this testimony),
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.\3\ The act also gives the
Administrator responsibility for carrying out a national exercise
program to test and evaluate national preparedness for responding to
all-hazards, including an influenza pandemic.
---------------------------------------------------------------------------
\3\ Pub. L. No. 109-295, Title VI.
---------------------------------------------------------------------------
Other evolving federal leadership roles include those of PFOs and
FCOs. To assist in planning and coordinating efforts to respond to a
pandemic, in December 2006 the Secretary of Homeland Security
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 resources support in a
presidentially declared major disaster or emergency. However, the
relationship of these roles to each other as well as with other
leadership roles in a pandemic is unclear.
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 on these
relationships. 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 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.
It is also unclear whether the newly established national and
regional positions for a pandemic will further clarify leadership roles
in light of existing and newly emerging plans and issues. 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.\4\ We also
reported in May 2007 that FEMA has predesignated five teams of FCOs and
PFOs in the Gulf Coast and eastern seaboard states at risk of
hurricanes. However, there is still some question among state and local
first responders about the need for both positions and how they will
work together in disaster response.\5\
---------------------------------------------------------------------------
\4\ GAO, Homeland Security: Management and Programmatic Challenges
Facing the Department of Homeland Security, GAO-07-398T (Washington,
D.C.: Feb. 6, 2007).
\5\ GAO, Homeland Security: Observations on DHS and FEMA Efforts to
Prepare for and Respond to Major and Catastrophic Disasters and Address
Related Recommendations and Legislation, GAO-07-835T (Washington, D.C.:
May 15, 2007).
---------------------------------------------------------------------------
More recently, DHS reviewed the NRP and its supplemental documents.
One of the issues this review intended to address was clarifying 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 over the FCO during an emergency. On
September 10, 2007, DHS released a draft National Response Framework to
replace the NRP, for public comment. Comments on the framework are due
October 11, 2007, and comments on the supplemental documents, such as
revised Emergency Support Function specifications, are due by November
9, 2007.
Exercising and Testing of Plans Is Crucial in Ensuring Capacity
Disaster planning, including for a pandemic influenza, needs to be
tested and refined with a rigorous and robust exercise 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.\6\
---------------------------------------------------------------------------
\6\ GAO, Hurrican Katrina: GAO's Preliminary Observations Regarding
Preparedness, Response, and Recovery, GAO-06-442T (Washington, D.C.:
Mar. 8, 2006).
---------------------------------------------------------------------------
While 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.\7\ The only national multisector pandemic exercise to date
was a tabletop simulation conducted by members of the cabinet in
December 2005. 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 Post-Katrina
Reform Act.
---------------------------------------------------------------------------
\7\ Congressional Research Service, Pandemic Influenza: Domestic
Preparedness Efforts, RL 33145 (Washington, D.C.: Feb. 20, 2007).
Gaps in the National Strategy and Plan Limit Their Usefulness
Our work found that the Strategy and Plan do not address all of the
characteristics of an effective national strategy as 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.
Specifically, we found that the documents fully address only one of
the six characteristics of an effective national strategy--problem
definition and risk assessment--because they identified the potential
problems associated with a pandemic as well as potential threats,
challenges, and vulnerabilities. The Strategy and Plan did not address
one characteristic--resources, investments, and risk management--
because they did not discuss the financial resources and investments
needed to implement the actions called for and therefore, do not
provide a picture of priorities or how adjustments might be made in
view of resource constraints. They partially addressed the four
remaining characteristics, as shown in table 1.
Table 1: 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, and X
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.
------------------------------------------------------
More specifically, the following are highlights of some of the gaps
in the Strategy and Plan.
The Strategy and Plan do not address resources,
investments, and risk management. 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, one of the primary objectives of domestic vaccine
production capacity is for manufacturers to produce enough
vaccine for the entire U.S. population within 6 months.
However, the Plan 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.
State and local jurisdictions were not directly
involved in developing the Strategy and Plan. Neither the
Strategy nor Plan described the involvement of key
stakeholders, such as state, local, and tribal entities, in
their development, even though these stakeholders would be on
the front lines in a pandemic and the Plan identifies actions
they should complete. Officials told us that state, local, and
tribal entities were not directly involved in reviewing and
commenting on the Plan, but the drafters of the Plan were
generally aware of their concerns.
Relationships and priorities among action items are
not always clear. While some action items depend on other
action items, these linkages are not always apparent in the
Plan. 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 that focused
on such issues as human health, animal health, and
transportation and borders considerations.
In addition, we found that 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.
Performance measures are focused on activities that
are not always linked to results. 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 linkages to outcomes
and results 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.
The linkage of the Strategy and Plan with other key
plans is unclear. 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 the relationships with these two
strategies. In addition, the Plan does not specifically address
how the Strategy, Plan, or other related pandemic plans should
be integrated with the goals, objectives, and activities of the
national initiatives already in place, such as the interim
National Preparedness Goal.
Further, the Strategy and Plan do not provide sufficient detail
about how the Strategy, action items in the Plan, and a
proposed set of agency plans are to be integrated with other
national strategies and frameworks. 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.
The Plan does not contain a process for monitoring and
reporting on progress. 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. 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
monitoring process for those actions items for which nonfederal
entities have the lead responsibility does not appear to exist.
Additionally, there is no explicit timeline for the HSC to
report on the overall progress and thus, when progress is
reported is left to the HSC's discretion.
The Plan does not describe an overall framework for
accountability and oversight. hile the plan contains broad
information on roles and responsibilities and describes
coordination mechanisms for responding to a pandemic, it does
not, as noted earlier, clarify how responsible officials would
share leadership responsibilities. In addition, it does not
describe an overall accountability and oversight framework.
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 oversight mechanism for the action items
that fall to state and local governments or the private sector.
This is a concern since 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
accountable for carrying out the action.
Procedures and time frames for updating and revising
the Plan were not established. 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 exercises, or to incorporate other
needed changes. Although the Plan was developed as initial
guidance and was intended to be 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.
Opportunities Exist To Clarify Federal Leadership Roles and Improve
Pandemic Planning
A pandemic poses some unique challenges and would be unlike other
emergencies given the likelihood of its duration and geographic
coverage. 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
implementation of pandemic plans could have substantial consequences,
both in the short and long term.
Since no national pandemic exercises of federal leadership roles
and responsibilities have been conducted since the release of the Plan
in May 2006, and key leadership roles continue to evolve, rigorous
testing, training, and exercising is needed. Exercises test whether
leadership roles and responsibilities, as well as procedures and
processes, are clear and well-understood by key stakeholders.
Additionally, they help identify weaknesses and allow for corrective
action to be taken before an actual emergency occurs. Consequently, in
our August 2007 report, we recommended 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. 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 and responsibilities are
clearly understood by state, local, and tribal governments; the private
and nonprofit sectors; and the international community. DHS and HHS
concurred with the recommendation, and DHS stated that it is taking
action on many of the shortfalls identified in the report.
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 and also set expectations for states and
communities, the private sector, and global partners. The extent to
which the Strategy and Plan fail to adequately address key areas could
have a critical impact on whether key stakeholders and the public have
a clear understanding of their roles and responsibilities. However,
gaps in the Strategy and Plan limit their usefulness as a management
tool for ensuring accountability and achieving results. The plan is
silent on when information will be reported or when it will be updated.
Although the HSC publicly reported on the status of action items in
December 2006 and July 2007, it is unclear when the next report will be
issued or how much information will be released. 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.
Therefore, in our August 2007 report we recommended that the HSC
establish a specific process and time frame for updating the Plan. We
stated that this process should involve key nonfederal stakeholders and
incorporate lessons learned from exercises and other sources. Further,
we stated that the Plan could 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. The HSC did not comment on the draft report.
Mr. Chairman and Members of the Subcommittee, this completes my
statement. I would be pleased to respond to any questions that you
might have.
Mr. Langevin. Thank you for your statement.
I would now recognize Dr. Jolly to summarize his statement
for 5 minutes.
Welcome.
STATEMENT OF DR. B. TILMAN JOLLY, ASSOCIATE CHIEF MEDICAL
OFFICER, MEDICAL READINESS, OFFICE OF HEALTH AFFAIRS,
DEPARTMENT OF HOMELAND SECURITY
Dr. Jolly. Thank you, Mr. Chairman, Ranking Member McCaul
and members of the subcommittee. Thank you for the opportunity
to testify before the subcommittee to discuss the progress of
the National Strategy for Pandemic Influenza and its
Implementation Plan.
Before I begin, I would like to take this opportunity to
thank you and members of the full committee on behalf of
Secretary Chertoff for your continued willingness to work
alongside the Department to provide leadership in protecting
and ensuring the security of our homeland.
I would also like to thank our partners at the Department
of Health and Human Services and others with whom we work every
day.
Pandemic influenza is unique. It is likely to come in
waves, passing through communities of all sizes across the
nation and the world simultaneously. The pandemic may last as
long as 18 months.
An unmitigated 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, including our nation's critical
infrastructure and key resources based on illness and related
absenteeism.
DHS has been and remains actively engaged with its federal,
state, local, territorial, tribal and private sector partners
to prepare our nation and the international community for an
influenza pandemic.
As outlined in the Implementation Plan, DHS is responsible
for the coordination of the overall domestic federal response
during an influenza pandemic, including implementing policies
that facilitate compliance with recommended social distancing
measures, developing a common operating picture for all federal
departments and agencies, and ensuring the integrity of the
nation's infrastructure, domestic security, and entry and exit
screening for influenza at the borders.
In working with our partners, such as HHS, the State
Department and USDA, DHS has developed and implemented a number
of initiatives and outreach to support continuity of operations
planning for all levels of government and private-sector
entities.
I will highlight a few noteworthy accomplishments and
responsibilities under the Implementation Plan particular to
DHS. DHS produced and released the Pandemic Influenza
Preparedness, Response and Recovery Guide for Critical
Infrastructure and Key Resources.
The guide has served to support business and other private
sector pandemic planning by complementing and enhancing, not
replacing, their existing continuity planning efforts.
With that in mind, DHS and its partners developed the guide
to assist businesses whose existing continuity plans generally
do not include strategies to protect human health during
emergencies like a pandemic.
As a next step, DHS is currently leading the development of
specific guides for each of the 17 critical infrastructure and
key resource sectors using the security partnership model.
In coordination with other federal departments and
agencies, DHS is developing a coordinated government-wide
planning forum. An initial analysis of the response
requirements for federal support has been completed.
From this analysis, a national plan defining the federal
concept for coordinating response and recovery operations
during a pandemic has been developed and will be undergoing
interagency review.
Utilizing this planning process, a coordinated federal
border management plan has been developed and is currently also
in review. This process included a wide range of partners.
DHS has also conducted or participated in federal and state
interagency pandemic influenza exercises and workshops and
forums with critical infrastructure key resources owners and
operators.
Consistent with his role under Homeland Security
Presidential Directive 5, Secretary Chertoff pre-designated
Vice Admiral Vivien Crea, the Vice Commandant of the U.S. Coast
Guard, as the national Principal Federal Official, or PFO, for
pandemic influenza, and has pre-designated five regional PFOs
and 10 deputy PFOs.
Likewise, our partners have pre-designated infrastructure
liaisons, Federal Coordinating Officers, senior officials for
health as well as defense coordinating officers.
Vice Admiral Crea and the regional PFOs have participated
in multiagency training and coordination sessions regarding
preparedness duties.
Additionally, the PFO teams have begun outreach both
nationally and in their regions in advance of the more
formalized exercise program which is being developed by DHS.
On an ongoing basis, DHS participates in interagency
working groups to develop guidance, including community
mitigation strategies, medical countermeasures, vaccine
prioritization and risk communication strategies.
In closing, significant progress has been made in national
preparedness for pandemic influenza. In fact, September is
National Preparedness Month, which encourages all Americans to
prepare for emergencies and take necessary actions for all
hazards.
DHS looks forward to continuing its partnership with the
federal interagency, state, local, tribal, territorial and
private sector stakeholders to complete the work of pandemic
preparedness and to further the nation's ability to prepare
for, respond to and recover from all hazards.
Thank you again for the opportunity to testify on behalf of
the Department of Homeland Security on these issues of critical
importance to our nation's security and well-being. I would be
happy to answer any questions you might have.
[The statement of Dr. Jolly follows:]
Prepared Statement of B. Tilman Jolly, MD
Mr. Chairman, Ranking Member McCaul and Members of the
Subcommittee:
Thank you for the opportunity to testify before the Subcommittee to
discuss the progress of the National Strategy for Pandemic Influenza
and its Implementation Plan. I am Dr. Til Jolly, Associate Chief
Medical Officer for Medical Readiness, within the Office of Health
Affairs at the Department of Homeland Security (DHS). Before I begin, I
would like to take this opportunity to thank you and Members of the
full Committee on behalf of Secretary Chertoff for your continued
willingness to work alongside the Department to provide leadership in
protecting and ensuring the security of our homeland. I would also like
to thank our partners at the Department of Health and Human Services
(HHS) and others with whom we work every day.
To begin, I would like to take a few moments to review some basic
facts about pandemics and their potential impacts on our nation.
Pandemic influenza occurs when a novel strain of influenza virus
emerges that has the ability to infect humans and to cause severe
disease, and when efficient and sustained transmission between humans
occurs. This scenario creates unique challenges. Unlike other
incidents, a pandemic is not a singular event, but is likely to come in
waves, each lasting weeks or months, passing through communities of all
sizes across the nation and the world simultaneously. The complete
pandemic cycle may last as long as 18 months. Based on projections
modeled by the Department of Health and Human Services from prior
pandemics, 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,
including our nation's critical infrastructure and key resources, as
many of our nation's workforce could be absent for extended periods of
time, either sick themselves or caring for loved ones at home.
The Implementation Plan for the National Strategy for Pandemic
Influenza was released over a year ago by the President?s Homeland
Security Council to guide our nation's preparedness and response to an
influenza pandemic. DHS has been actively engaged with its federal,
state, local, territorial, tribal, and private sector partners to
prepare our nation and the international community for an influenza
pandemic. As outlined in the Implementation Plan DHS is responsible for
the coordination of the overall domestic Federal response during an
influenza pandemic, including implementation of policies that
facilitate compliance with recommended social distancing measures,
development of a common operating picture for all Federal departments
and agencies, and ensuring the integrity of the Nation?s
infrastructure, domestic security and entry and exit screening for
influenza at the borders.
To date DHS has accomplished over 80% of the requirements outlined
in the Implementation Plan. DHS recognizes the key role of HHS in its
responsibilities to lead clinical disease surveillance and rapid
detection during a pandemic, and, under Emergency Support Function
(ESF)-8, to plan, prepare, mitigate and support the coordination of the
public health and medical emergency response activities during a
pandemic under ESF-8, including the deployment and distribution of
vaccines and of antivirals and other life-saving medical
countermeasures from the Strategic National Stockpile. DHS also
recognizes the Department of State's role to lead the coordination of
international efforts including U.S. engagement in a broad range of
bilateral and multilateral initiatives that build cooperation and
capacity to fight the spread of avian influenza, to prepare for a
possible pandemic, and to coordinate with our neighbors Canada and
Mexico. The Department of Agriculture (USDA) conducts surveillance for
influenza in domestic animals and animal products, monitoring wildlife
in partnership with the Department of the Interior, and working to
ensure an effective veterinary response to a domestic animal outbreak
of highly pathogenic avian influenza.
In working with our partners DHS has developed and implemented a
number of initiatives and outreach to support continuity of operations
planning for all levels of government and private sector entities. I
will highlight a few noteworthy accomplishments and responsibilities
under the Implementation Plan particular to DHS.
DHS produced and released the Pandemic Influenza Preparedness,
Response, and Recovery Guide for Critical Infrastructure and Key
Resources (Guide). Tailored to national goals and capabilities, and to
the specific needs identified by the private sector, this business
continuity guidance represents an important first step in working with
the owners and operators of critical infrastructure to prepare for a
potentially severe pandemic outbreak. The Guide has served to support
business and other private sector pandemic planning by complementing
and enhancing, not replacing, their existing continuity planning
efforts. With that in mind, the Federal government developed the Guide
to assist businesses whose existing continuity plans generally do not
include strategies to protect human health during emergencies such as
those caused by pandemic influenza or other diverse natural and manmade
disasters.
DHS is currently leading the development of specific guides for
each of the 17 critical infrastructure and key resource sectors. These
include agriculture, food, and water, public health, emergency
services, telecommunications, banking, defense systems, transportation,
energy resources, and others. These guides are being developed
utilizing the security partnership model and in collaboration with our
Federal partners.
In coordination with other Federal departments and agencies, DHS is
developing a coordinated government-wide planning forum. An initial
analysis of the response requirements for Federal support has been
completed. From this analysis, a national plan defining the federal
concept for coordinating response and recovery operations during a
pandemic has been developed and will be undergoing interagency review.
Utilizing this planning process, a coordinated federal border
management plan has been developed and is currently in review. This
process included state, local, tribal, territorial, and private sector
stakeholder input, along with our Federal interagency partners.
DHS has conducted or participated in federal and state interagency
pandemic influenza exercises which have focused on varied issues
related to preparedness. These exercises have included:
FEMA's Determined Accord series for continuity of
operations with federal, state, local, tribal, territorial
entities.
Several Customs and Border Protection exercises--
addressing transportation and border challenges.
A U.S. Fire Administration tabletop exercise for
development of best practices models and protocols for EMS, 911
Call Centers, Fire Services, Emergency Managers, Law
Enforcement and Public Works. This will allow for further
integration of a unified Federal, state, local and private
sector emergency response capabilities.
HHS sponsored regional National Governors Association
Pandemic Influenza exercises, CDC funded and provided guidance
for state and local exercises, and DOD pandemic influenza
exercises.
Multiple workshops and forums with the owners and
operators of critical infrastructure and key resources.
Consistent with his role under Homeland Security Presidential
Directive (HSPD) 5, Secretary Chertoff pre-designated Vice Admiral
Crea, the Vice Commandant of the US Coast Guard, as the National
Principal Federal Official (PFO) for pandemic influenza and has pre-
designated five regional PFOs and 10 deputy PFOs. Likewise, our
partners have pre-designated Infrastructure Liaisons, Federal
Coordinating Officers, Senior Officials for health as well as Defense
Coordinating Officers. VADM Crea and the Regional PFOs have
participated in several training sessions regarding preparedness
duties, and have held two orientation sessions to date. These sessions
included updates from the Department of State, the Department of
Agriculture, the Department of Health and Human Services, the
Department of Defense, as well as updates from various DHS components
and staff regarding their work to date. Additionally, the PFO teams
have begun outreach both nationally and in their regions in advance of
a more formalized exercise program which is being developed by DHS.
On an ongoing basis, DHS participates in interagency working groups
to develop guidance including community mitigation strategies, medical
countermeasures, vaccine prioritization, and risk communication
strategies. These groups bring together a wide range of federal
partners to discuss preparedness issues.
In closing, significant progress that has been made in national
preparedness for pandemic influenza. In fact, September is National
Preparedness Month, which encourages all Americans to prepare for
emergencies and take the necessary actions for all-hazards. Many of
these accomplishments can be incorporated into an all-hazards framework
to promote the national culture of preparedness. DHS looks forward to
continuing its partnership with the federal interagency, state, local,
tribal, territorial, and private sector stakeholders to complete the
work of pandemic preparedness and to further the nation's ability to
prepare for, respond to, and recover from all-hazards.
Thank you again for the opportunity to testify on behalf of the
Department of Homeland Security on these issues of critical importance
to our nation?s security and well-being. I would be happy to answer any
questions you might have.
Mr. Langevin. Thank you, Dr. Jolly, for your testimony.
I now recognize Dr. Vanderwagen to summarize his statement
for 5 minutes.
Welcome.
STATEMENT OF RADM W. CRAIG VANDERWAGEN, MD, ASSISTANT SECRETARY
FOR PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Vanderwagen. Thank you, Mr. Chairman.
And it is a great opportunity to come and visit with you
about the partnership between the legislative and the executive
branch that I think we have moved forward aggressively on over
the last couple of years.
As you may know, the Assistant Secretary for Preparedness
and Response was established approximately 10 months ago under
the Pandemic and All-Hazards Preparedness Act.
We had significant responsibilities transferred to us and
significant new authorities. We have tried to execute those in
a very timely manner. We have transferred NDMS. We have
transferred the Hospital Preparedness Program. We have
transferred the ESAR-VHP program.
We have taken on new authorities under BARDA. We are
standing up the National Biodefense Science Board. And the list
of accomplishments requested under the law we would be happy to
share with you in detail if you are interested.
However, I would note that in August there was a transfer
of responsibility to the ASPR from the Assistant Secretary for
Health for pandemic planning and coordination within HHS.
So I am here today to speak specifically about pandemic
flu. And you have articulated, I think, most succinctly the
threat, the risk and what the challenges are.
I believe that over the last year there has been
significant progress. I agree with Mr. McCaul. There has been
significant progress jointly among the states and the federal
government.
There is a strong federal lift strategically planned to
purchase the ability to develop and deliver vaccines as part of
our overall strategic goal.
And as was noted by both of you, our strategic goal here,
our theory of victory, is a delay of this disease spread and a
reduction in the absolute number of individuals who will be
affected by the disease.
And the first line investments to assure that included the
development of domestic capability in the production and
delivery of vaccines and antivirals and diagnostics that would
allow us to be very astute in the way we employed those
techniques in reducing the rate of infection.
But as has been noted, it is also now time for us to review
and update what are the gaps that still persist and what are
the challenges that are ahead.
Our belief is it should be built upon some of the success
that has occurred.
Accordingly, with our vaccine investments and our
investments in newer antivirals and in diagnostic capability,
we are monitoring those production capabilities and we have set
up milestones for that performance of activity and our funds
that we have remaining, and we have spent about $3 billion or
so.
The balance of funds are established as a reserve to
continue that progress and development as they achieve certain
milestones.
But there are persistent gaps, as I said. Those gaps exist
in respiratory protection. They exist in how we can make
community mitigation even more effective potentially using the
expanded production capability in antivirals to perhaps use
antivirals in a prophylactic mode as opposed to a pure
treatment mode, which is where our previous investments have
been.
These next steps, however, have to be built upon the
concept of shared responsibility. Again, as you both stated,
the role of state and local governments, of business and,
indeed of individuals and families needs to be explored
further.
And their engagement in the gap filling process needs to be
active and needs to be present. We have started that process
here in the last couple of months and have met with business
interests, public health interests, medical interests in
Seattle, in Raleigh.
We have other opportunities planned ahead for engagement of
those stakeholders in this process. And we think that that will
help us to determine how to divide the shared responsibility
for development of approaches to meeting those gaps.
There is a sustainment challenge that also lies out there
in front of us as well, because what we build today has to be
sustained over time, and those issues will need to be
addressed. If not right this minute, they will need to be
addressed in the way ahead.
So in summary, ASPR has stood up. We accept the
responsibility. We work closely with our partners and view
ourselves as being an integral part of the team led by DHS, but
our shared responsibility demands that we reach out to our
stakeholders at the state, local, family and individual level
if we are going to move ahead with the new steps that remain to
be addressed.
And with that, I will stop and be happy to address
questions.
[The statement of Dr. Vanderwagen follows:]
Prepared Statement of RADM William C. Vanderwagen, MD
Chairman Langevin, Ranking Member McCaul, and distinguished Members
of the Subcommittee, thank you for the opportunity to present the
progress HHS has made in national preparedness for pandemic influenza.
Over the past two years, with the $5.6 billion supplemental funding we
received from Congress, we have worked closely with our International,
Federal, state and local partners to advance our preparedness for
pandemic influenza. While we all understand that preparedness is a
process that is never completed, the advances I will highlight for you
today demonstrate what can be accomplished when there is a shared
vision and support for preparedness. The threat of a pandemic remains a
real one, and I appreciate that in holding this hearing, you share our
sense of urgency about our preparedness.
As you know, the President released the National Strategy for
Pandemic Influenza in November 2005, followed by a detailed
Implementation Plan from the Homeland Security Council (HSC) in May
2006. The HSC Implementation Plan assigned over 300 tasks across the
Federal Government to improve our Nation's preparedness for pandemic
influenza. HHS has made substantial progress in the nearly 200 action
items assigned to our department, completing over 80% in one year.
These gains are real and measurable, and they cover a broad range of
preparedness, including enhancing our international laboratory
networks, developing and releasing guidance on community-based measures
to mitigate the effects of a pandemic, and expanding the Medical
Reserve Corps program. We also released the HHS Pandemic Plan and HHS
Implementation Plan, and those are available alongside additional
information and planning resources at www.pandemicflu.gov. I will
highlight for you specific accomplishments in three areas: State and
Local Preparedness, Countermeasure Procurement and Advanced
Development, and Federal Preparedness.
All of these accomplishments are consistent with the mission of my
office, which Congress created in December 2006 through the Pandemic
and All-Hazards Preparedness Act. The ASPR mission is to lead the
nation in preventing, preparing for, and responding to the adverse
health effects of public health emergencies and disasters, and the
vision we see is ``A Nation Prepared.'' Within HHS, my office
coordinates the preparedness and response enterprise, which focuses on
the continuum of preparedness from research and development of medical
countermeasures to response delivery platforms that support state and
local responders in reaching our citizens during an incident.
Our preparedness for pandemic influenza involves a shared
responsibility among our entire Department, our partners in the
International community, the Federal interagency, state, local, tribal
and territorial governments, the private sector, and, ultimately,
individuals and families. In addition, we believe our planning for an
influenza pandemic is part of an all-hazards approach. The gains we
make in increased preparedness and response capability for pandemic
influenza will help us across the spectrum of public health emergencies
and disasters.
Enhanced State and Local Preparedness
By the end of this year, the Department will have awarded over $600
million in emergency supplemental funding through the Centers for
Disease Control and Prevention (CDC) and ASPR to 62 awardees: 50
states, five U.S. territories, three Freely Associated States of the
Pacific, New York City, Los Angeles County, Chicago, and the District
of Columbia to upgrade state and local capacity in regard to pandemic
influenza preparedness. The funding has occurred in three general
phases:
Phase 1--$100 Million
Senior HHS officials, led by Secretary Leavitt, conducted Pandemic
Influenza Preparedness Summits in every state to facilitate community-
wide planning and to promote shared responsibility for pandemic
preparedness. To assess gaps in pandemic preparedness and guide
preparedness investments, CDC created an assessment tool for awardees
to use in evaluating their own jurisdiction's current state of
preparedness.
The awardees were required to submit: (1) a gap analysis; (2) a
proposed approach to filling the identified gaps; and (3) an associated
budget for the critical tasks necessary to address those gaps. High
priority areas being addressed include:
Exercising pandemic incident command systems,
Linking animal and human surveillance systems,
Augmenting laboratory capacity,
Plans for vaccine and antiviral distribution, mortuary
affairs, and continuity of essential functions
Phase 2--$250 Million ($225 million for four priority activities
and $25 million for competitive demonstration projects)
Of the Phase 2 funds, $225 million were used for four priority
activities: (1) work with jurisdictional colleagues in emergency
management, community organizations and other agencies to develop a
jurisdictional workplan to address gaps identified by the assessment
process; (2) develop and exercise an antiviral drug distribution plan;
(3) develop a pandemic exercise schedule to include--at a minimum--
medical surge, mass prophylaxis, non-pharmaceutical public health
interventions and the antiviral drug distribution exercises; and (4)
submit the jurisdictional pandemic influenza operational plan.
Three planning priorities were targeted--state/local exercises of
key plans (mass vaccination using seasonal flu clinics, community
containment, medical surge); developing antiviral distribution plans;
and review of statewide pandemic influenza plans.
85% of the awardees used seasonal influenza
vaccination clinics to exercise mass prophylaxis plans
(Highlights--some state medical boards used Emergency Medical
Technicians (EMTs) and paramedics to act as vaccinators to
reduce the burden on public health staff; some states used
drive-through clinics to increase throughput and enforce social
distancing.)
83% of the awardees participated in tabletop exercises
of non-pharmaceutical interventions and plans to contain the
spread of pandemic influenza. (Emphasis on school closing
decisions and discouragement of large public gatherings; the
majority of awardees responded that gaps in their existing
plans were identified and that further planning refinements are
necessary to produce viable and executable plans. Funding in
Phase 3 will help address these gaps.)
Over 50% of the awardees reported conducting exercises
of antiviral distribution plans.
The public health and medical components of this
funding supplement have included two of the Target Capabilities
identified as part of National Preparedness under Homeland
Security Presidential Directive 8: Mass Prophylaxis and Medical
Surge.
97% of the awardees have submitted pandemic influenza
operational plans that involve interaction and partnership with
law enforcement and emergency management (antiviral
distribution), education, and business sectors (community
mitigation and continuity of operations).
The remaining $25 million Phase 2 funds will be used to make
pandemic influenza emergency supplemental awards based on performance.
The funds will be awarded competitively to awardees that successfully
propose a plan to develop, implement and evaluate pandemic influenza
interventions. Proposals will be solicited for public health
interventions for which there are few data, unclear consequences, or
inconclusive effectiveness.
Phase 3--$250 Million Available.
CDC has awarded $175 million of Phase 3 funding to support
awardees' efforts to fill gaps identified in Phases 1 and 2. The
awardees will be required to utilize the tools developed under the
auspices of the Homeland Security Exercise Evaluation Program to create
planning, training, and exercise evaluation programs. A total of $75
million will be awarded as supplements to the 62 entities that
currently receive awards through the Hospital Preparedness Program
(HPP) cooperative agreements. Applications are due in October 2007.
The HPP transferred from the HHS Health Resources and Services
Administration (HRSA) to ASPR in March of this year as directed under
the PAHPA. The Program has continued to focus on enhancing surge
capacity. Priorities for Medical Surge that were evaluated as part of
the state plan review are as follows:
States have the ability to report available beds which
is a requirement in the 2006 Hospital Preparedness Program
Cooperative Agreement,
Effective use of civilian volunteers as part of the
Emergency System for Advance Registration of Volunteer Health
Professionals (ESAR-VHP) and Medical Reserve Corps (MRC)
programs,
Planning for Alternate Care Sites,
Development of Health Care Coalitions that promote
effective sharing of resources in surge situations--Will be
funding 10 partnership demonstration projects for $18.1 million
in fiscal year 2007, and
Plans for providing the highest possible standards of
care in situations of scarce resources. ASPR partnered with the
HHS Agency for Healthcare Research and Quality (AHRQ) in the
development of a Community Planning Guide on Mass Medical Care
with Scarce Resources. The guide includes a pandemic influenza
case study.
The remainder of the Phase 3 funding has been allocated to the HPP
program for upgrading state and local pandemic influenza preparedness
capacities. This funding will establish stockpiles of critical medical
equipment and supplies, as well as be used to develop plans for
maintenance, distribution and sharing of those resources. This funding
may also be used to support the planning and development of alternate
care sites (ACS) and medical surge exercises for pandemic influenza.
Examples of allowable activities include:
Stockpiles of ventilators, ancillary supplies and
oxygen,
Personal protective equipment (PPE) and infection
control supplies,
Alternate care sites--staffing, operational plans and
exercises,
Mass fatality plans and equipment and supplies, and
Medical surge exercises.
T3Countermeasure Procurement and Advanced Development
HHS has also made tremendous progress in addressing the Pandemic
influenza medical countermeasure goals that emanate from the HSC
Implementation Plan.
These goals are listed on the table below.
---------------------------------------------------------------------------
\1\ This figure assumes a severe, 1918-like pandemic.
Vaccine To establish and maintain a dynamic pre-pandemic influenza
Goal #1 vaccine stockpile available for 20 million persons: H5N1
stockpiles (40 million doses)
------------------------------------------------------------------------
Vaccine To provide pandemic vaccine to all U.S. citizens within 6
Goal #2 months of a pandemic declaration: pandemic vaccine (600
milliondoses)
------------------------------------------------------------------------
Antivirals To provide influenza antiviral drug stockpiles for
Goal #1 treatment of pandemic illness for 25% of U.S. population
who we estimate will become clinically ill during a
pandemic (75 million treatment courses \1\)
------------------------------------------------------------------------
Antivirals To provide influenza antiviral drug stockpiled for
Goal #2 strategic limited containment at the onset of a pandemic
(6 million treatment courses)
------------------------------------------------------------------------
Diagnostics To develop new high throughput laboratory and Point of Care
Goal #1 influenza diagnostics for pandemic virus detection
------------------------------------------------------------------------
Advanced Development:
Cell-based vaccines. Current influenza vaccines are
based on influenza virus grown in fertilized chicken eggs. In
an effort to modernize influenza vaccine manufacturing for
greater flexibility and less vulnerability, and to increase
domestic manufacturing capacity with the potential for surge
production, six contracts were awarded in 2005-06 for $1.1
billion to develop seasonal and pandemic cell-based influenza
vaccines towards U.S.-licensure. In 2007 three manufacturers
will begin late stage pivotal clinical evaluation of their
cell-based influenza vaccines with sights set on Biologics
License Application (BLA) submissions to FDA in 2008. Further,
one manufacturer has already broken ground on new state-of-the
art cell-based influenza vaccine manufacturing facilities in
North Carolina with completion scheduled in 2010. The ultimate
goal here is to strengthen the U.S. domestic manufacturing
system and to ensure adequate U.S.-based production capability.
Antigen-sparing vaccines. To stretch the domestic pre-
pandemic influenza vaccine manufacturing capacity further and
to provide vaccines with broad cross-protective immunity, three
contracts were awarded in January 2007 for $133 million to
develop antigen-sparing pandemic influenza vaccines towards
U.S.-licensure. These H5N1 vaccine candidates formulated with
new adjuvants show great promise in mid-stage clinical
evaluation with expectations that one or more will be submitted
as BLAs in 2008 for licensure. An adjuvant is a vaccine
additive that amplifies the immune response. HHS is
coordinating studies with a number of manufacturers to
determine whether these adjuvants can be used safely and
effectively with H5N1 vaccine antigens currently in the
stockpile that have been produced by different manufacturers--a
key step toward expansion of the pre-pandemic vaccine stockpile
supply.
Next generation vaccines. Our investments in cell
culture technology mentioned above will expand production
capability. Because of the time vaccine production takes (20--
23 weeks from identification of the pandemic virus), we are
also investing in next generation vaccines with shorter
production timelines. To provide pandemic vaccine earlier after
the onset of a pandemic, a synopsis for a contract solicitation
was issued in August 2007 to seek proposals for advanced
development of next generation recombinant influenza vaccines
over the next 3--5 years with the goal of accelerating the
development of new vaccine technologies that will greatly
shorten vaccine production timelines in a pandemic.
Antivirals. Until recently, there was little incentive
for manufacturers to develop new approaches to treat influenza.
Currently, we have only two classes of antiviral drugs that are
effective against influenza. Only one of those classes of
drugs, the neuraminidase inhibitors (oseltamivir
[Tamiflu'] and zanamivir [Relenza']), is
being actively stockpiled because of the development of
resistance to the older class of antiviral drugs. As our
options are limited, we need new antiviral candidates in case
clinically significant resistance to our current stockpile of
antiviral drugs develops. To promote the advanced development
of new influenza antiviral drugs towards U.S.-licensure, a
contract was awarded in January 2007 for $102 million to
develop peramivir, a neuraminidase inhibitor that may be
administered in life-threatening influenza illnesses. This drug
is in mid-stage clinical evaluation presently. In 2008 more
influenza antiviral drug candidates will emerge in the pipeline
that may be ready for advanced development and eligible for
funding. We need new antiviral candidates should the viruses
become resistant to the currently available antivirals.
Diagnostics. To provide healthcare professionals with a means
to distinguish pandemic influenza viruses from other
respiratory pathogens including seasonal influenza viruses,
four contracts for $12 million were awarded in November 2006
for development of rapid point-of-care diagnostic devices. By
the end of 2007, two of these devices will be evaluated
independently for further clinical development with
expectations of licensure submissions in 2009. Solicitations to
award contracts for development of high throughput laboratory
and single-use home diagnostics for pandemic influenza are also
expected to be issued by the end of 2007.
Ventilators. To close the enormous gap in the availability of
ventilators, which will be essential to treat severely-ill
patients during an influenza pandemic, a Blue--Ribbon Panel
will be assembled this fall to establish the product
requirements for a next generation affordable, mobile
ventilator. A contract solicitation will be issued early in
2008 for the advanced development of next generation
ventilators.
Federal Stockpile Acquisitions.
Vaccines. To establish pre-pandemic vaccine
stockpiles, multiple contracts have been awarded for over $900
million between 2004 and 2007 to U.S.-licensed influenza
vaccine manufacturers to develop and produce at commercial
scale using licensed manufacturing processes and facilities for
egg-based inactivated split H5N1 vaccines against multiple
virus clades. These stockpiling efforts led to the U.S.
licensure of the first H5N1 vaccine in April 2007. To date 15
million vaccine single antigen doses have been manufactured as
bulk vaccine product, and 11 million more doses will be
manufactured this fall for a total of 26 million by the end of
2007. I should note, however, that while pre-pandemic vaccine
stockpiles are based on our best assumptions of what virus
strains are likely to present during a pandemic, they may not
closely match the virus that actually arrives. Finally,
Secretary Leavitt issued a Pandemic Response Emergency
Preparedness Act declaration in January 2007 to provide
comprehensive liability immunity for manufacturers and
administrators of H5N1 influenza vaccines.
Antiviral Drugs. The Pandemic Influenza Plan seeks to ensure
the availability of antiviral treatment courses for 25 percent
of the U.S. population or 81 million treatment courses. To meet
the federal stockpile goal of 50 million treatment courses of
influenza antiviral drugs for treatment during a pandemic, 37.5
million treatment courses of U.S.-licensed neuraminidase
inhibitors were purchased in 2006-07 and delivered to the
Strategic National Stockpile (SNS). The U.S. now has domestic
manufacturing capabilities for these drugs. The remaining 12.5
million treatment courses will be purchased in fiscal year 08
upon approval of the pending appropriation request. To assist
States in meeting their collective pandemic stockpile goal of
31 million treatment courses of influenza antiviral drugs, $170
million was allocated to subsidize state purchases made using a
federal contract with manufacturers of antiviral drugs. To date
the States have purchased 15.1 million treatment courses of
influenza antivirals for their stockpiles and are expected to
reach the overall goal by July 2008.
Ventilators. The SNS will purchase 2000 new ventilators in 2007
for distribution during a pandemic or as required in other all
hazards incidents and states can invest in ventilator
procurements through the investments being managed through the
HPP program.
Syringes. The SNS will purchase in excess of 20
million syringe/needle units in 2007 for usage with pre-
pandemic influenza vaccines.
Infrastructure Building.
Vaccines. To utilize existing facilities for pandemic
influenza vaccine manufacturing, two contracts were awarded in
May 2007 for $133 million for retrofitting existing domestic
biological manufacturing facilities for production of egg-based
influenza vaccines and providing warm base operations for up to
five years. A contract solicitation for proposals to establish
new domestic cell-based influenza vaccine manufacturing
facilities is also expected in 2008 with manufacturing capacity
requirements of at least 150 milliondoses of pandemic vaccine
within six months.
While we have been making great strides with procurement and
advanced development we have also drafted guidance on how to maximize
these investments. We believe it's important to work with stakeholders
in order to finalize that guidance, and that preparedness is best
achieved not just by focusing on producing additional products, but by
assuring that they are deployed and used optimally. This requires
leadership in developing guidance and promoting preparedness,
consultation with those who have a critical role in implementation
(including states and professional societies), and understanding and
overcoming any barriers to achieving success.
Federal Preparedness Planning
For the past six months, ASPR has been a lead partner in the
development of a U.S. Government-wide Pandemic Influenza Strategic
Plan, which describes what steps Federal Departments will take to
respond to the emergence of a novel influenza virus abroad and here in
the homeland. This strategic planning process further codifies the HHS
public health and medical responsibility to mitigate illness and reduce
deaths during a pandemic through the provision of medical
countermeasures and materiel, community mitigation guidance, necessary
laboratory and surveillance tools, and some of the nation's finest
public health and medical emergency response personnel.
The Department's operational plan for pandemic influenza response
details how HHS will fulfill its important responsibilities and how
ASPR will coordinate the deployment and utilization of HHS assets and
expertise. This plan, or playbook as we call it, will be further
refined in the coming months to ensure a seamless integration with the
U.S. Government-wide Plan. Further, HHS Operating Divisions including
the CDC are developing their own detailed operational plans that are
aligned with the Department's plan to enable a cohesive Departmental
preparedness approach. A goal for next year is to work with states to
develop regional playbooks that will continue to promote integrated
planning across all tiers of government.
HHS held a number of exercises to test the operational plans I have
described. ASPR hosted Department-wide exercises with senior leadership
to test how we will leverage the full scope of HHS resources and
capabilities in response to pandemic influenza. ASPR has pre-identified
six Senior Federal Officials to work in coordination with the pre-
designated Pandemic Influenza Principal Federal Officials, and our
Senior Federal Officials are engaged in State-sponsored exercises
taking place in their regions. In addition, CDC launched an extensive
exercise program to identify planning gaps and stretch the limits of
their assumptions and response strategies.
The last two exercises have included state participation to promote
seamless preparedness integration across the different tiers of
response. The state participants were actively involved in the planning
meetings leading up to the conduct of both of these CDC-sponsored
exercises.
April 25--27, 2007: coordinated activities with State
Emergency Operations Centers (EOCs) and State Health Department
EOCs from three states (Arkansas, Florida and Ohio).
August 14--16: CDC Pan Flu Surge exercise, where
representatives from five states (Arkansas, Florida, Georgia,
Michigan and Ohio) served in our Exercise Control Group to
replicate the activities of their states and those of other
states that were not actively represented.
The CDC's Division of Strategic National Stockpile (DSNS) also
conducted a number of exercises. For example:
--Operation Wild Canary, a full scale exercise executed in
partnership with the State of Iowa. The purpose of the exercise
was to test antiviral distribution from the federal stockpile
down to the local treatment facility. During the exercise the
DSNS deployed training material exactly replicating Iowa's pro-
rata allocation of antiviral drugs to the state receipt, stage,
and store site in Des Moines. From there the state sent
antiviral drugs on a pre-established allocation to distribution
hubs throughout the state. Local treatment facilities then
received their antiviral allocation from the distribution hubs.
Some examples of state and local promising practices in pandemic
influenza activities include:
--Maine
Formed pandemic influenza workgroups on all
levels including:
Statewide Steering Committee including
public constituents
County Pandemic Influenza Planning
Groups including public constituents and
association and governmental members at the
county and local level.
Intergovernmental Pandemic Influenza
Planning Committee including the Departments of
Agriculture and Inland Fisheries, the Maine
Emergency Management Agency, and Maine
Emergency Medical Services.
--Wisconsin
The state has significantly improved planning for treatment centers
resources and personnel. As a result of pandemic influenza planning the
state has a better understanding of their treatment facilities'
capabilities, as well as an accurate location and point of contacts for
each treatment facility, which has helped to improve their overall
level of preparedness.
--Atlanta, Georgia and Los Angeles County, California
Both cities are working with the Business
Executives for National Security (BENS) to engage local
corporations in preparedness planning.
In an upcoming exercise drill, the L.A.
Business Force/Homeland Security Advisory Council will
be the first private-sector representative ever
included in a security exercise at the vital Port of
Los Angeles/Long Beach, the gateway for 40 percent of
all U.S. trade.
Thank you for the opportunity to present the progress HHS has made
in national preparedness for pandemic influenza. With your leadership
and support, we have made substantial progress. The threat remains
real, and we have much left to do to ensure that we meet our mission of
a Nation prepared for a potential influenza pandemic.
This concludes my testimony. I will be happy to answer any
questions.
Mr. Langevin. Thank you, Dr. Vanderwagen.
I thank all the witnesses for their testimony. Each of the
members will have 5 minutes to question the panel. And I now
recognize myself for questions.
Again, I want to thank you all for your testimony. Let me
address a question to the panel.
To me, it would seem that an effective system of planning
and response to pandemic influenza is one in which it would
have broad-ranging benefits in other areas of public health
threat, whether naturally occurring or manmade.
So my question would be how does pandemic flu planning help
in other ways? And what are we doing to ensure that it is
helping in other ways?
Again, it would seem to me that we should be thinking about
this as we develop plans so that we might spend dollars more
efficiently.
Dr. Jolly. I will begin, sir. I think that you are correct.
There are a number of ways in which a pandemic planning process
can assist other planning processes.
In the health focus, which I think Admiral Vanderwagen will
focus on, there are certainly some areas of synergy. And
outside of the purely health realm, when we think of operations
of critical infrastructures, continuity planning and complex
organizational structures that may be required for complex
crises, the pandemic planning we have done related to those
issues certainly can help those.
There are some unique aspects, as we have discussed, with
pandemic--the length of time that it lasts, the wave nature and
some of the specific issues. But some of those continuity
planning processes and the operational planning at the federal
level certainly apply to those.
And we have really taken the tack now of trying to apply
those to a broader set of hazards.
Dr. Vanderwagen. Yes, I agree with Til wholeheartedly, and
I will just give you one example. And, sir, I have been to your
state, Rhode Island, and visited the Rhode Island Medical
Center, visited with the staff up there.
There are great examples of how all-hazards preparedness as
applied to pandemic or any other disaster are demonstrated, and
I expect that we will hear some of that today.
This first part of the week I was down in North Carolina
for a couple of days visiting with them around their planning.
And last year alone in North Carolina, they conducted 87
exercises for pandemic flu.
But what was clear was that they were using assets that
they would deploy and involve in just about any sort of hazard.
Hurricane is one that they live with frequently there in North
Carolina.
But the exercises, while focused on pandemic flu and some
of the unique qualities, as Til suggested, they were exercising
the whole system--the communication between public safety and
health, the delivery of assets to communities, and that could
be for any infectious disease or other demand.
So I think there are some great examples where the states
and localities really are using pandemic to build an all-
hazards response base while having the unique capabilities for
pandemic.
Ms. Steinhardt. If I can just add to Dr. Vanderwagen's
comments, the important thing in any emergency that requires
the enormous amount of coordination across multiple sectors and
multiple actors is building those relationships before
emergencies occur.
You can't start getting to know people in the middle of an
emergency. So having those relationships in place,
understanding who one is supposed to turn to--all of that is
very vital to being able to respond effectively in an
emergency.
And so any kind of planning and exercising that forges
those relationships is going to benefit us in any emergency.
Mr. Langevin. Let me follow up with this. Some would argue
that the grant strategy--the grants that are offered to states,
for example, are not well coordinated and that, you know, you
can spend money if it is for preparedness for pandemic flu, but
you are not able to spend that money in other areas that could
be part of the response system to a public health threat.
And someone argued that there is not good coordination in
how you are writing and offering grants to states and other
areas.
So can you comment on that, you know, the coordination
between DHS and HHS grants, for example?
Dr. Vanderwagen. Yes. And there is a real risk there of a
disconnect and bureaucratic silos at play.
But I think that the most recent amount of money that we
provided to the states, $75 million for pandemic flu, included
guidance that would allow them to purchase assets that have
utility in other than pandemic flu--ventilators, for instance,
may be useful in a variety of settings not limited to pandemic
flu.
In terms of engagement with our DHS colleagues--and again,
I will give you a North Carolina example. They were looking to
develop a paratransit capability for evacuation of patients
with special needs.
And what they were able to do was merge USERA grants, CDC
grants and the ASPR Hospital Preparedness grants using the
authorities of each one of those to put together a package that
would allow them to purchase and have constructed the
appropriate paratransit equipment.
It takes extreme work and communication on our part at the
federal level, but I think the states that have been most
successful also take a collaborative internal approach to this
where they look at all the grants and they look at how they can
use it for the ends that they are really trying to achieve.
So I think it takes work at both the federal level and the
state level to try and make those work effectively together.
Dr. Jolly. And I would concur with Admiral Vanderwagen and
Ms. Steinhardt that the opportunities in pandemic preparedness
based on the grant funding for pandemic really play out in
overall all-hazards preparedness, giving public health,
emergency management, security, law enforcement--all the
elements that come to play in complex crises--an opportunity to
sit down together and go through scenarios, while mostly
focused on pandemic in this case, allow them to get to know
each other, get to know their various needs and the unique
aspects of their roles, and help to coordinate those, and can
only have benefits for other crises.
Ms. Steinhardt. I hope to be able to answer your question
better in a few months, because we are actually looking at
these issues of state and local planning and exercising
currently in an ongoing engagement for this committee.
But I want to say now that one of the things we have
observed is that this is a longstanding, I think, challenge to
better integrate not only the funding but the communities
themselves of public health and emergency management.
They still speak different languages. They have different
vocabularies. They are getting to know one another. And I think
around pandemic planning is the immediate task at hand, but it
will work in other areas as well.
Mr. Langevin. Thank you.
Let me turn to the GAO, to Ms. Steinhardt, for a minute. I
was troubled when I read in the GAO's report on the National
Strategy that both the Secretary of Homeland Security and the
Secretary of Health and Human Services would be co-leaders
during an influenza pandemic but that how they would actually
lead at the same time has not yet been made clear.
You made reference to this in your opening statement. Could
you expand on this finding?
Ms. Steinhardt. This is a kind of new model for us in the
federal government to have these shared responsibilities.
I think it is appropriate to recognize that for the major
challenges like pandemic influenza that face the nation that it
does take the efforts of multiple departments and competencies.
But how exactly that works still has to be figured out.
That is why we argued so strongly for having tests and
exercises. Only when you go through a simulation of an actual
situation can those kinds of details be worked out.
We understand it conceptually, but how it would work in
practice we need to see.
Mr. Langevin. As a follow up, Dr. Jolly and Dr.
Vanderwagen, during a pandemic when would the Secretary of
Homeland Security lead and when would the Secretary of Health
and Human Services lead?
Dr. Jolly. Well, under the construct, the Secretary of
Homeland Security is responsible for overall domestic
preparedness and incident coordination at the federal level and
would lead the overall federal activities, while the Secretary
of Health and Human Services led the health and medical
response, which is a very large job just by itself.
And our PFO group, our Principal Federal Official group,
working with HHS, FEMA, our operations--and others are working
through the exact specifics of how that works down at the lower
levels.
Dr. Vanderwagen. Yes. I agree with that. We, I think,
understand ourselves as having a finite and discrete
responsibility under the overall leadership of DHS.
Where this becomes an incident that has national
significance, there is no question, the leadership resides with
the Secretary of Homeland Security.
With regards to public messaging, with regards to strategic
thinking about application of assets to the medical and public
health piece, we have that responsibility, but that still
resides under the overall leadership of the secretary of
homeland security.
And the constructs--that is, the actual operational
planning--is as Til has described, and I think Ms. Steinhardt
did as well. That operational construct is now being
established.
And in fact, we have tested it some in that Vice Admiral
Crea and some of her folks have participated in CDC exercises
around pandemic flu to begin to see how the health nests under
her leadership.
Mr. Langevin. Well, this is obviously an area we want to
continue to watch and to be involved in. Obviously, we can't
wait until an actual event occurs and hope that, you know, the
left hand knows what the right hand is doing.
And as Ms. Steinhardt pointed out, you know, conducting
exercises and actually simulating this is really the best way
to make sure it is going to function properly in the event that
a national emergency like this would occur.
With that, I now recognize--well, actually, before I do
that, let me just welcome the gentleman from New Jersey, Mr.
Pascrell, who has joined us, and was an original member of the
Homeland Security Committee when it was a select committee and
left for a brief time when he went on the Ways and Means
Committee. And now he is back joining us, as well as being on
Ways and Means, also on the Homeland Security Committee.
Welcome back, Bill.
The chair now recognizes the gentleman from Texas for 5
minutes for the purpose of questions.
Mr. McCaul. I thank the chairman.
I do want to welcome back Mr. Pascrell to the committee. It
is good to have you here.
As we approach the flu season, it is a joyful time of the
year. I get to drag my five little children, kicking and
screaming, to the doctor's office, holding them down as they
get their flu vaccines.
We try to anticipate the next sort of mutation, if you
will, in preparation for this vaccine, and overall I think we
have been very fortunate in terms of our ability to predict and
foresee.
The issue with a pandemic would be a mutation that would be
unforeseen, some sort of variation like the avian flu that
suddenly becomes, you know, transmittable human to human.
And that is a scenario that we obviously are most concerned
with. And how do we stop it? As we all know, it has been about
40 years since we have had one in this country, and we are long
overdue for that.
My first question is more science related. So for the two
doctors that we have, in terms of vaccines, you know, it seems
to me that in the event we have a pandemic that is an
unforeseen mutation of a virus, the ability to quickly develop
a vaccine would be key in terms of minimizing the loss of life.
I know that there has been some research now going from
egg-based to cell-based vaccines, and I would like to hear from
you in terms of the progress that we have made in that regard
in terms of developing, you know, vaccines that we can get to,
you know, the market more quickly.
Dr. Vanderwagen. Yes. Well, it is an extremely good
question, and one that we have really tried to focus on pretty
steadily.
Our investments have been with multiple manufacturers to
develop cell-based technologies for production in this country.
That doesn't provide a tremendous amount of shortening of
the time period from the time the virus is identified until you
have a manufacturing capability to put it out there, but it is
a cleaner, more modern and sophisticated technology that
doesn't depend on chickens for eggs.
And in an avian flu, that is--you know, we have
biosecurity and so on, but still, it is shifting to
that new technology.
Where we think there will be the breakthrough in terms of
reducing the production time from the identification of virus
to the actual production capability of vaccine at production
levels is with the development of a recombinant vaccine.
And we are about ready to award a contract for a producer
of that, and we hope to have a couple producers in that game,
not limited to one, that would allow us to see if, in fact, the
promise of an 8-week turnaround instead of a 20-week turnaround
is as we think it might be.
That combined with the developments now in adjuvant
therapies added to the antigen--remember, the vaccine has an
antigen that stimulates your immune system--now the
technologies of developing adjuvants that augment that immune
response at a much lower dose of antigen.
And the research in this area is also very promising. If it
plays out, and there are clinical studies under way now to
assure that they are safe and effective, as advertised--if that
works out, it may give us a twentyfold increase in our existing
pre-pandemic vaccine stockpiles.
And in the future, if we have to produce a new vaccine, it
will change the character of how much we need to develop an
antigen in order to get a good vaccine with a good immune
response.
So progress is moving along very smartly in the technology
and science arena here with vaccine development for influenza,
particularly pandemic flu.
Mr. McCaul. Can you forecast maybe the time frame that that
technology would be available?
Dr. Vanderwagen. I think the RPA that is the recombinant
technology for this--proof of concept is out there. We are
talking a year or so. 2010 we think we will have that
available--is the way we are thinking about it.
The adjuvants that I mentioned to you may occur sooner than
that. In 2009, perhaps we will have final clinical efficacies,
and everybody will be convinced that we have got the safe
product for pre-use.
Mr. McCaul. Dr. Jolly?
Dr. Jolly. We certainly support that. I think the planning
and the community mitigation guidance and other strategies take
into account the current situation, but we certainly support
further research.
And I think this argues for a couple of things. One, the
vaccine research for pandemic can only benefit vaccine research
for other diseases.
And I think there is a wide range of things both in the
emergency management realm and just in public health that this
can really help. If this technology works for one, it can
certainly work for others.
I also applaud and sympathize with your efforts to get your
family vaccinated.
And that really argues for our increased vigilance and
message to the public about seasonal flu and to really utilize
the seasonal flu vaccine because seasonal flu is not a trivial
matter just by itself.
Mr. McCaul. Well, I find it to be a very exciting and
promising area, and the other--this is also sort of more
science-based, but antivirals--where are we with those?
And also, where are we with the stockpiles in the event of
an outbreak?
Obviously, as you mentioned, Dr. Vanderwagen, about the
idea of them being used as both prophylactic and after
exposure--do we have enough, say Tamiflu and other antivirals?
Do we have enough stockpiled right now in the event there is a
pandemic outbreak?
Dr. Vanderwagen. Well, let me answer the first part of that
first, and that is where are we. We are on plan. You may recall
that we strategically made the decision to purchase enough to
treat everyone that we thought would be at risk and got ill.
And so the planned investment was to purchase adequate
amounts with our state partners to treat 25 percent of the
population who we projected would be ill. We are on plan for
that.
The last purchases to fill out the 81 million treatment
courses for that will occur in fiscal year 2008.
With regards to the use of antivirals in prophylaxis, we
made that strategic decision about purchasing for treatment
because at the time, production capability was fairly limited,
15 million or so a year treatment courses.
Now that production capability is much more robust than
that, which gives us the opportunity to visit with our
stakeholder partners--the states, businesses, even down to
individuals and families--the question of where is the
responsibility for shared acquisition if, in fact, the science
supports the use.
And that is sort of a question that we are analyzing right
now. What is the science base for using antivirals in a
prophylaxis environment and what are the risks of doing that in
terms of developing resistance, for instance, and therefore
losing the utility of the tool?
We are also developing additional antivirals, at least one
that attacks at the same spot that Relenza and Tamiflu--I am
drawing a blank there--aging, what can I tell you--that is
similar in action but can be delivered through the bloodstream
parenterally, as we say in medicine, which for extremely sick
people would be another alternative that would be very useful.
So there are developments on the horizon. There are some
gap questions to be answered both from a science perspective
and from a shared responsibility perspective.
But if, in fact, the science supported it and we worked out
the shared responsibility, there is a potential use there in
post-exposure prophylaxis and for those who are at high risk
like medical workers of acquiring the disease.
We know, for instance, in seasonal influenza 15 percent to
30 percent of health workers in hospitals taking care of very
ill people with flu get sick. So there is another target
population at risk that we need to consider.
Mr. McCaul. Ms. Steinhardt and Dr. Jolly, if you could
comment on that as well, is our stockpile, national stockpile,
of antivirals adequate to meet the need if a pandemic occurs
this year?
Ms. Steinhardt. Well, I can't say that we have assessed
that specifically, but I think a lot of it has to do with
whether we change the use of antivirals.
If we are using them just as treatment--and obviously, we
don't have enough to treat the entire population--or if we are
going to use them prophylactically.
But I must say that this is now the opportunity to think
about if we do have limited supplies, whether of antivirals or
vaccines, if we were to have pandemic influenza in the nearer
term, what sort of priorities are we going to set for
distributing those supplies. That is, I think, a key question
for us.
Mr. McCaul. Dr. Jolly?
Dr. Jolly. I would agree with Craig. We are building up the
stockpile, and we are shifting from an analysis that involves
purely treatment to potentially a larger amount of that for
prophylaxis and trying to develop the science base, because
there is no medicine that doesn't have a risk associated with
it, and there certainly are risks associated with wide use.
And the other point I would make is that antivirals are not
the entire answer. We really want to be careful to make
everyone understand that having an antiviral isn't necessarily
100 percent curative or preventative.
But in fact, it is incorporated into a wide range of
strategies that don't include pharmaceuticals such as the
community mitigation strategies that were led by the CDC with
multiple agencies involved that are really part of the overall
strategy.
Mr. McCaul. I see my time has expired, but I want to close
with the same point that the chairman made, and that is the
exercises. I think there has been one exercise to date. Was
that a tabletop or was that a field exercise?
Ms. Steinhardt. It was a tabletop exercise, and it was
before actually the issuance of the Plan.
Mr. McCaul. The Plan. Yes.
I would strongly encourage, Dr. Jolly, that you consider
conducting a field exercise in the event a pandemic broke out.
I think having worked with the Joint Terrorism Task Forces
in my prior lifetime, I think when you do these things in the
field, you kind of get a better sense for who is supposed to be
doing what in a real sense.
So with that, I will yield whatever time in have left,
which I see is zero.
[Laughter.]
Mr. Langevin. And then some.
[Laughter.]
Mr. Langevin. I thank the gentleman.
And the chair now recognizes the gentleman from New Jersey
for 5 minutes.
Mr. Pascrell. Thank you, Mr. Chairman. It is good to be
back.
I follow this issue very carefully, and I have some
questions for the Rear Admiral Vanderwagen.
I want to thank you for convening the hearing. I appreciate
the administration appearing today. This is very important,
because I believe that the sense of urgency shown by Congress
and the administration has diminished, and not increased, in
recent months.
Despite the fact that the World Health Organization has now
confirmed a total of 327 cases of avian flu and 199 deaths,
including recent disturbing reports out of Vietnam Egypt and
Indonesia.
To date, I understand the administration has requested and
Congress has appropriated $6.1 billion for implementation of
the $7.1 billion National Strategy on Pandemic Influenza,
including $2.3 billion most recently on the fiscal year 2006
emergency supplemental appropriations bill.
This administration has been evasive in answering questions
about why the funds allocated for the purchase of the antiviral
drugs have not been spent to complete the stockpile.
I have here in my hand three letters. These three letters
went to Secretary Leavitt from the House Republican leadership
in June, one letter came from the House Democratic leadership
in August, and the last letter is from Senator Thad Cochran,
who wrote that letter to the Secretary in September.
All of them ask the question why we have only purchased
enough drugs for 15 percent of the population when the NSPI
calls for 25 percent of the population to be covered by the
stockpile.
And my first question to you, Rear Admiral, is why have
these letters gone unanswered?
Dr. Vanderwagen. I can't speak to that, sir. I will have to
ask that question of the executive secretary and the folks who
manage the correspondence.
Mr. Pascrell. You don't know why the letters have been
unanswered. I mean, they came from all sectors of the campus
here, and we still don't have an answer for them.
This committee doesn't have an answer for them. The
Congress doesn't have an answer for them. Who in God's name do
you think you are kidding? Who do you believe we'll believe on
this side of the aisle--excuse me, if I may continue--the
urgency of this situation?
Who do you think is going to believe you?
Dr. Vanderwagen. Let me go back to your first question.
Mr. Pascrell. Sure.
Dr. Vanderwagen. I have just been informed that two of
those answers have been provided to the Hill for the first two
of those, and we will provide documentation of that for you,
sir.
Mr. Pascrell. We don't have those answers yet, and we would
like to have those answers.
Dr. Vanderwagen. Right.
Mr. Pascrell. Do you know what is contained in them?
Dr. Vanderwagen. I haven't seen them myself, no, but I----
Mr. Pascrell. In addition, Rear Admiral, how much of the
funding allocated to you has been set aside for antiviral
purchases, and how much has been set aside for vaccine purchase
and development?
Dr. Vanderwagen. Right.
Mr. Pascrell. Have all of these funds been spent?
Dr. Vanderwagen. We currently have obligated $3.2 billion,
$2.4 billion of that for vaccines including cell-based
vaccines, antigen sparing activities, facilities retrofitting,
international vaccine development, the H5N1 pre-pandemic
stockpile.
We have a total commitment of $796 million for antivirals.
That includes $103 million for advanced development, $523
million for federal stockpiles and $170 million for state
stockpiles. We have an additional $27 million invested in
advanced diagnostics.
Mr. Pascrell. So how much haven't you spent?
Dr. Vanderwagen. We have a balance remaining that is set
aside in reserve for those advances that we have agreed to work
with the vaccine companies to do. We are monitoring their
progress. We have agreed to milestones. And when they achieve
those milestones, we would continue to make investments.
That was our business arrangement with those producers,
that if they hit certain milestones in production, we would
then advance further investment.
Mr. Pascrell. Why is it that we apparently had--and there
is no seamless solution. We understand that. But why haven't we
used our capacity to purchase and stockpile the very drugs we
know that work?
And we have sent mixed signals to the pharmaceuticals. They
are not going to continue to make these unless, you know, we
purchase them.
And if they have been tried, if they have been tested, it
seems to me that we are circumventing the solution, not
exercising urgency and talking about developing another set of
solutions, which you know is going to be 3 years to 5 years.
Let's go back to the history of these things.
I don't understand that. Maybe you can help me understand.
Dr. Vanderwagen. The investments that we were to make for
antivirals for treatment are on plan. We have stated
forthrightly that we would purchase X amount in 2007 and we
would purchase the balance of that in 2008. There has been no
real change in that plan. That is out there in the marketplace.
That has been a consistent message from us.
The advanced development investments we think by 2010 will
have payoffs that have huge benefits for the population, as you
may have heard me respond to Mr. McCaul.
Mr. Pascrell. I think that, Mr. Chairman, if I may
conclude--my time is up--I really still don't sense the urgency
that is necessary that on both sides of the aisle has been
expressed and is not being implemented.
And I would hope that through the chair and through the
ranking member that this could be brought to bear, in that we
can get the answers that they talk about in these letters,
which started 4 months ago, 5 months ago.
And now we are hearing at this committee hearing that there
are answers but they just haven't gotten to us yet. Would you
please follow up on that, sir?
Mr. Langevin. Absolutely.
Mr. Pascrell. Thank you.
Mr. Langevin. I can guarantee that to the gentleman. And I
thank the gentleman from New Jersey for his questions. You
clearly have not lost your passion for homeland security
issues. I thank the gentleman.
In consultation with the ranking member, what we would like
to do--there are two votes on right now. Hopefully that will go
quickly.
We would like to go for a second round of questions with
this panel, since many members are at markups and other
meetings right now. We will go for a very brief second round
with this panel and then go to the second panel when we return.
I would say that we should be back here in about 20
minutes.
With that, the committee stands in recess.
[Recess.]
Mr. Langevin. The committee will come to order. I thank the
witnesses for waiting.
And I understand that at least two of our guests have a
meeting at the White House actually for an exercise that is
going on right now, so we are going to be very brief and adhere
to the 5-minute rule, and hopefully we will get you out of here
in just a couple of minutes.
If I can talk to Dr. Jolly and Dr. Vanderwagen--let me
address my questions there We were talking about earlier how we
can better coordinate homeland security and HHS grants with
respect to pandemic flu that could be also beneficial in other
areas.
Let me ask this. How can we better coordinate all public
health grant monies, especially those that come from HHS?
Again, my understanding is that not all grants have common
goals and performance measures.
My question is: is there a system in place at HHS to
coordinate things like goals and performance measures,
especially when there are multiple grants, perhaps some from
CDC, some from the ASPR, dealing with the same topics, such as
pandemic flu?
Dr. Vanderwagen. Yes, sir, Mr. Chairman, and indeed, there
is a fairly well defined process of planning that goes into the
grant guidance that we provide, remembering that the Centers
for Disease Control's investments are more targeted at public
health types of interventions and public health programs at the
community level, where the hospital preparedness dollars are
really targeting the medical side of that.
Our interest here is to see the public health and the
medical community act in concert on these activities. And
unfortunately, in this country, we had seen a large gap develop
between the public health and medical communities.
And one of our goals is to bring them into greater
proximity. Accordingly, we are not only trying to align the
expectations from the grants, recognizing that public health is
slightly different than clinical medicine, we are also now
trying to bring our grants into the same time sequence as the
DHS grants so that the states and communities are looking at
the whole grant package in the same time frame rather than
looking at one in March and then one in August and then maybe
one in October.
And so those are the active steps that we are taking. First
meeting before we issue guidance to assure that they
synchronize. And secondly, to try and fix the timing on our
public health and hospital grants to align more closely with
DHS and their timing.
Dr. Jolly. And to add on Admiral Vanderwagen's statement,
Mr. Chairman, the timing and sequence are quite important, and
also the content of the grants.
We have an active effort now growing within DHS and HHS to
communicate among those that are responsible for the grant
guidance at one agency so that the other agency knows what that
grant guidance is and can help to harmonize that.
And one of the roles--as you know, our office is a
relatively new office in Health Affairs. One of the roles of
our division of medical readiness is to take a look at the DHS
grants and also coordinate across the HHS grants and try to
harmonize those.
And it is going to be a stepwise process over time, but I
think we can make some real improvements in that.
Mr. Langevin. Well, I plan to pay particularly close
attention to that, and that will be part of our oversight as we
go forward. I think it is beneficial for both departments and
the country, and ultimately the states and our citizens are
going to benefit.
Very quickly, for DHS and HHS once again, when we conduct
exercises--we spoke about exercises earlier here, and practice,
and making sure that we are ironing out the issues before they
actually occur.
When we conduct exercises, it is important to conduct them
in the most realistic way possible and, to the extent we can,
use current requirements to show us how well we might do in
future situations.
During a pandemic, DHS and HHS will be the lead federal
agencies in terms of managing the response, as we discussed
earlier. I believe that we should test our systems now using,
for example, seasonal influenza as a proxy for pandemic
influenza.
So my question for you, Dr. Vanderwagen, is why don't you
take this year's influenza season and make a concerted effort
to see how many people we can vaccinate in the shortest period
of time, basically pretending that seasonal influenza is
actually pandemic influenza?
Can you get HHS programs such as the National Immunization
Program to step up and work with other HHS entities and systems
to exercise in this way?
Dr. Vanderwagen. Yes, sir. And in fact, in 2006 I--you
know, I live in Howard County up the road here, and the state
of Maryland was test driving its ability to deliver vaccines in
an event of a pandemic by using the seasonal flu as the test
bed.
And essentially, they had a drive-through approach so that
we could maintain social distancing and yet provide access to
vaccines for the population.
It took me 3 hours to get my vaccine, but it worked. And we
are promoting more of that kind of use of vaccination
opportunities as a test drive of how they would do mass
prophylaxis in the environment of a pandemic flu.
I think that is a capital idea. Some states have done it.
We are trying to promote it more holistically to all states.
I think Dr. Gerberding on Wednesday this past week, a week
ago, when she made the announcements regarding this year's
seasonal flu--that was one of the points that she tried to
make.
So I think we are on the same page with you, sir. It
remains for us to demonstrate to you how that went off.
Dr. Jolly. And I would agree that some of the operational
elements of vaccinating individuals and some of the other
things--countermeasure issues can benefit from those types of
exercises.
That is a very good idea, and something that other states
have tried and will continue to refine.
And on some of the larger exercise issues, we have plans
within our Principal Federal Official group to exercise within
that group and then lead that into a series of leadership level
interagency exercises and to culminate in another cabinet-level
exercise over a period of time as the schedule develops.
Mr. Langevin. Very good. Well, I see benefits across a
range of areas in conducting such an exercise, so--well, I
thank you for the answers.
And I now recognize the gentleman from Texas for 5 minutes
for questions.
Mr. McCaul. Thank you, Mr. Chairman.
I will be brief. We have a vote in, I think, 15 minutes.
Ms. Steinhardt, you mentioned in your testimony certain
gaps that are currently, in terms of our readiness, our
preparedness.
I would like, if you could, to focus on sort of the
highlights of those gaps and how we can do a better job.
Ms. Steinhardt. Yes, I would be happy to. Ones I think that
I wanted to highlight in particular--first, the fact that there
are--in the National Strategy and Plan there is no mention of
the resources that are going to be required to carry out the
Plan. There are well over 300 action items in the plan.
Dr. Vanderwagen and Dr. Jolly mentioned earlier the vaccine
program and supplemental appropriations. But there are many
others that are called for in the Plan beyond those that are
covered in the supplemental appropriations, and there is not
even an estimate of what would be entailed.
So that is one important gap. And certainly, from an
oversight perspective, it is really critical.
Another gap that we were particularly mindful of was the
fact that state and local and tribal entities weren't involved
in actually producing the plan and preparing the plan.
They are responsible for close to 100 of the action items,
either as the lead or in some sort of support capacity, and yet
they weren't consulted when the plan was being developed, and
that I think is something that needs to be addressed.
And then the plan itself--within the plan there is no
institutional process for updating it as new events unfold, as
we learn from exercises and so on. There is no process to
update the plan or to monitor progress on a regular basis.
There are several others that we point out in our report
and statement, but those are the ones I would highlight.
Mr. McCaul. Thank you.
And I do want to thank the witnesses again. I think we have
made some progress. And as Dr. Vanderwagen mentioned, I think
we are partners in this, and so I look forward to working with
you to make sure we are prepared. Thank you.
Mr. Langevin. I thank the gentleman.
And with that, no further questions. I thank the panel for
their testimony, your presence here today and for the work that
you are doing on behalf of the country.
And we look forward to continuing oversight in this area
and partnership with you in this effort. Thank you very much.
With that, the first panel is dismissed. And if we can have
the second panel come to the front. Very good.
Well, gentlemen, thank you for being here. I want to
welcome the second panel of witnesses.
Our first witness is Dr. Anthony Cirillo, the chief of the
Center for Emergency Preparedness and Response in the state of
Rhode Island Department of Health. He is also a practicing
emergency room physician.
In addition to that, prior to his present post, he was
chief of emergency medicine at Pawtucket Memorial Hospital in
Rhode Island.
Welcome, Dr. Cirillo.
Our second witness is Dr. Peter Shult. Dr. Shult is the
director of the Communicable Disease Division and Emergency
Laboratory Response and Chief Virologist of the Wisconsin State
Laboratory of Hygiene.
He is also clinical associate professor of the Department
of Medical Microbiology and Immunology at the University of
Wisconsin-Madison.
Welcome.
And our third witness is Dr. Michael Caldwell, commissioner
of the Dutchess County Health Department of Poughkeepsie, New
York. Dr. Caldwell is the immediate past president of the
National Association of City and County Health Officials.
He is also an internal medicine physician and a public
health officer with 12 years of experience in local public
health practice.
Our fourth witness is Dr. David Lakey, commissioner of the
Texas Department of State Health Services.
We want to welcome all of our panel here today. I thank all
four of our witnesses for their service to their states and to
the nation and again for being here today.
Without objection, the witnesses' full statements will be
inserted into the record. I now ask each witness to summarize
his statement for 5 minutes, beginning with Dr. Cirillo.
STATEMENT OF DR. L. ANTHOHY CIRILLO, CHIEF, CENTER FOR
EMERGENCY PREPAREDNESS AND RESPONSE, RHODE ISLAND DEPARTMENT OF
HEALTH
Dr. Cirillo. Mr. Chairman and members of the committee, I
would like to thank you for allowing me to testify today to
discuss the current successes and ongoing challenges in
planning and preparing for a pandemic influenza event.
I would like to share with you my dual perspective as both
the coordinator of public health emergency preparedness for our
nation's smallest state and as a practicing emergency physician
in an urban community hospital.
Today I can share with you that although significant
progress has been made in preparing the public health and
health care sectors for response to a pandemic, there is still
considerable work that needs to be done, and there are
challenges both in scope and depth of preparation that will
need to be addressed in order for our country to meet the
challenge of a pandemic event.
In Rhode Island, the Department of Health serves as the
sole public health agency within the state, as there is no
other city-or county-based public health infrastructure.
As such, the department is responsible for the
administration of all traditional public health programs both
promotional and protectional.
The Center for Emergency Preparedness and Response oversees
all public health emergency preparedness grants, including the
CDC Public Health Emergency Preparedness Grant and the Hospital
Preparedness Program Grant administered through the office of
the ASPR.
Under the leadership of U.S. Secretary of Health and Human
Services Michael Leavitt, who issued a challenge to prepare for
a pandemic during his state visits in 2006, Rhode Island
undertook a spectrum of activities.
The successes that have been achieved in pandemic
preparedness in Rhode Island have come, to a great extent, due
to the strength of our partnerships and working relationships
within the state and the New England region.
In Rhode Island, we have strived to develop an integrated
and coordinated system for the public health and health care
sectors to respond to any public health emergency, including a
pandemic.
Ongoing coordination with our hospitals through the
Hospital Preparedness Program facilitated the establishment of
10 health care coordinating service regions in the state in
order to respond to the needs for health care during a
pandemic.
Stockpiling of critical supplies at the state level,
including patient care equipment, personal protective
equipment, ventilators and other support materials has begun in
order to provide an initial cache of medical equipment needed
to supply alternate care sites during a pandemic.
Outreach and risk communication messaging in the senior
community, other special populations and the general public
through brochures, newspaper inserts, classroom materials and
public service announcements has already occurred.
Regional interstate coordination in pandemic preparedness
has also occurred among the six New England states and the
state of New York. Each of these states has participated
together in work groups focused on a number of pandemic topics.
This collaborative effort resulted in a 2-day summit and a
multistate tabletop exercise held to coordinate the interstate
response to a pandemic.
Despite the progress that I have described, there is still
considerable work to be done. Ongoing challenges include,
number one, inadequate funding and resources to purchase enough
material to ensure care of anticipated numbers of patients
during a pandemic.
Two, shifting and evolving federal grant priorities related
to pandemic flu and overall public health preparedness which
create inefficiencies in program management.
Three, the disincentives to the purchase of antiviral
medications Tamiflu and Relenza due to exclusion from the
shelf-life extension program of state health supplies of these
medications.
Now, as an emergency physician, I have personally witnessed
the increasing demand for medical care being placed on hospital
emergency departments. With the number of uninsured Americans
now in excess of 47 million, more and more individuals do not
have appropriate access to medical care.
In the absence of a medical home, people who experience
injury or illness will seek care in the one environment where
they know they will never be turned away, and that is the
emergency department.
However, emergency departments today are overcrowded. Surge
capacity is diminished or being eliminated altogether.
Ambulances are diverted to other hospitals. And the shortage of
medical specialists is worsening.
According to data recently released by the CDC, emergency
department visits are at an all-time high of 115 million in
2005. That was an increase of five million visits in just 1
year alone.
And from 1995 through 2005, emergency department visits
increased by 20 percent, while the number of functioning and
operating emergency departments decreased by 9 percent.
Because of the extraordinary demands that a pandemic will
place on the health care delivery system, it is imperative that
we are able to engage the general public and encourage them to
assume responsibility for their own preparedness.
Just as the saying goes that all disasters are local, so is
the response to a disaster. In the truest sense for a pandemic,
this means that preparedness must begin with individuals,
families, neighborhoods and communities.
It is critical to the successful response that we develop a
culture of preparedness in this country in order to ensure that
those who have the means to prepare for themselves do so.
If we can accomplish this, then the burden of response on
government will be reduced so that scarce resources available
can be shifted and allocated to those who are most at risk.
In conclusion, I would like to share with you the following
closing thoughts. States and local health entities are willing
partners in the development of systems to respond to a pandemic
event or other public health emergency.
However, the resources and support of the federal
government are essential to creating and sustaining the
capability and capacity required to prepare for and respond to
all public health emergencies.
Incorporating new grant requirements and updates to
national planning documents related to a pandemic or other
public health emergency requires considerable time at the state
and local level and utilization of resources in order to
effectively reach the entire health care responder community
and the general public.
Therefore, it is critical that all federal preparedness
programs related to pandemic or other public health emergencies
be more closely aligned and coordinated so that we at the state
level can more effectively develop an appropriate response to
all public health emergencies.
Mr. Chairman and members of the committee, I thank you for
the opportunity to discuss these important issues with you
today and would be happy to answer any questions you may have.
[The statement of Dr. Cirillo follows:]
Prepared Statement of L. Anthony Cirillo, MD, F.A.C.E.P
Mr. Chairman and members of the committee, my name is L. Anthony
Cirillo, M.D., F.A.C.E.P. I serve as the Chief of the Center for
Emergency Preparedness and Response (CEPR) for the State of Rhode
Island Department of Health and as a practicing emergency department
physician employed by Emergency Medicine Physicians (EMP), a single
specialty medical group practice.
I would like to thank you for allowing me to testify today to
discuss the current successes and ongoing challenges in planning and
preparing for a pandemic influenza event. I would like to share with
you my dual perspective as both the coordinator of public health
emergency preparedness for our nation's smallest state and as a
practicing emergency physician in an urban community hospital. As of
today, I can share with you that although progress has been made in
preparing the public health and healthcare sectors for response to a
pandemic influenza event, there is still considerable work that needs
to be done, and there are challenges both of scope and depth of
preparation that will need to be addressed in order for our country to
meet the challenge of a pandemic influenza event.
The Rhode Island Experience
The Rhode Island Department of Health serves as the sole public
health agency within the state as there is no other city / county based
public health infrastructure. As such, the department is responsible
for the administration of all traditional public health promotional and
protection programs, including Healthy People 2010, food and water
protection, laboratory, epidemiology and disease control. Beginning in
early 2006, the Center for Emergency Preparedness and Response (CEPR)
was established by Dr. David Gifford, the Director of Health. CEPR was
established to coordinate all public health emergency preparedness
activities on behalf of the department. CEPR serves as the liaison
entity, on behalf of HEALTH, for all other emergency preparedness
efforts within the state and is the designated lead agency for
Emergency Support Function 8 (ESF-8), Health & Medical, within the
state's Emergency Operations Plan.
In my role as the Chief of CEPR, I serve as the Principal
Investigator, on behalf of the department, for both the CDC Public
Health Emergency Preparedness (PHEP) and the Hospital Preparedness
Program grant administered through the office of the Assistant
Secretary for Preparedness and Response (ASPR) within the Department of
Health & Human Services. In addition, CEPR serves as the representative
entity in participation in the development of investment justifications
under the Department of Homeland Security grant funded programs.
The successes in pandemic preparedness in Rhode Island have come,
to a great extent, due to the strength of our partnerships and working
relationships within the state and the New England region. I would like
to acknowledge here today, two other Rhode Islanders who represent key
partners within the state with whom the Department of Health has worked
closely with in these efforts. Mr. Thomas Kilday, who currently serves
as the Homeland Security Grant Manager at the Rhode Island Emergency
Management Agency, is a paramedic and previously served as the Program
Manager for the Hospital Preparedness Program at the Department of
Health. Mr. Peter Ginaitt, who currently serves as the Director of
Emergency Preparedness for Lifespan, the state's largest healthcare
system, is a former state representative and retired Captain of
Emergency Medical Services for the City of Warwick.
In Rhode Island, we have strived to develop an integrated and
coordinated system for the public health and healthcare systems to
respond to a pandemic influenza event or other public health emergency.
Ongoing coordination with our hospitals through the Hospital
Preparedness Program facilitated the establishment of ten healthcare
coordinating service regions in the state for pandemic influenza. In
this model, each of the ten acute care hospitals within the state would
serve as the coordinating entity for a geographic area. Utilizing the
Hospital Incident Command System for management of healthcare in that
area, each hospital will report to the Department of Health as the
coordinating entity for all ESF-8 activities within the state.
Volunteers during a pandemic event will be coordinated through
Volunteer Reception Centers (VCRs) which will be managed by the
Volunteer Center of Rhode Island (VCRI), a non-profit organization with
expertise in volunteer coordination. VCRI has been provided funding
through the Pandemic Flu grants and has established a single, unified
statewide volunteer management system. VCRI will be able to open ten
volunteer reception centers simultaneously to manage volunteers
throughout the state. Volunteers will be pre-credentialed utilizing the
Emergency System for Advanced Registration of Volunteer Health
Professionals (ESAR-VHP), another program funded under the Hospital
Preparedness Program grant.
Stockpiling of critical supplies including patient care equipment,
personal protective equipment, ventilators, and other support materials
at the state level has begun in order to provide an initial cache of
materials to equip Alternate Care Sites (ACS) in each of the hospital
coordinated healthcare regions.
Outreach and risk communication messaging to the senior community,
other special populations, and the general public through brochures,
newspaper inserts, classroom materials, and public service
announcements has already occurred.
Regional interstate cooperation in pandemic preparedness planning
has also occurred among the six New England states and the State of New
York. Early in 2006, after US Secretary of Health and Human Services
Michael Leavitt's visits to the states to discuss pandemic
preparedness, coordinated planning and response to a pandemic event,
representatives from each of the Departments of Health in seven states
participated in workgroups on the following topics:
1. Community Containment
2. Personal Protective Equipment
3. Antiviral Medication / Vaccine Utilization
4. Laboratory Testing / Disease Surveillance
5. Fatality Management
6. Surge Capacity
These workgroups met in person or by teleconference for\ 3 months
culminating in a two-day summit held in Boston in late June 2006. These
workgroups identified common best practices among all the states, as
well as the areas of differing response strategies. A key lesson from
the summit meeting was that in order for there to be effective public
health response to a pandemic, this response needed to be coordinated
with state governmental leadership and emergency management agencies as
well. Therefore a tabletop exercise was held at the Naval War College
in Newport, RI in August 2006. Participating in this exercise was the
seven states noted above as well as representatives from the FEMA
Region I and HHS Region I offices.
Despite the progress referenced above, there is still considerable
work to be done. Ongoing challenges include:
1. Inadequate funding to purchase enough materiel to ensure
care of anticipated numbers of patients during a pandemic
influenza event, as federal funding for preparedness continues
to decrease.
2. Shifting and inconsistent federal grant priorities related
to pandemic flu and overall public health emergency
preparedness efforts which create inefficiencies in program
management.
3. Disincentives to the purchase of antivirals due to exclusion
of state held cache from Shelf Life Extension Program (SLEP).
4. Continued need to coordinate planning across state borders,
especially in those states with multiple and close state
borders.
The Emergency Department Experience
As a practicing emergency physician, I have personally witnessed
and shared with my colleagues across the country, the increasing demand
for clinical services being placed on emergency departments. With an
increase in the number of uninsured Americans now in excess of 47
million, more and more individuals do not have appropriate access to
medical care. In the absence of a medical home, people who experience
injury or illness of themselves or loved ones will seek care in the one
environment where they know they will never be turned away, the
Emergency Department. Emergency departments are the health care safety
net for everyone in this country--the uninsured and the insured.
Emergency departments are overcrowded, surge capacity is diminished
or being eliminated altogether, ambulances are diverted to other
hospitals, patients admitted to the hospital are waiting longer for
transfer to inpatient beds, and the shortage of medical specialists is
worsening. These are the findings of the Institute of Medicine (IOM)
report ``Hospital-Based Emergency Care: At the Breaking Point,''
released in June 2006.
On June 29, the Centers for Disease Control and Prevention (CDC)
released its results from its 2005 National Hospital Ambulatory Medical
Care Survey (NHAMCS), the longest continuously running, nationally
representative survey of hospital emergency department and hospital
outpatient department use.
According to the CDC data:
Emergency visits are at an all-time high of 115
million in 2005--an increase of 5 million visits in one year.
From 1995 through 2005, the number of emergency
department visits increased by 20%, from 96.5 million to 115.3
million visits annually. This represents an average increase of
more than 1.7 million visits per year.
During this same period, the number of hospital
emergency departments decreased by 9%, from 4,176 to 3,795.
Hospitals and Emergency Departments in this country are being
challenged to meet the everyday demand for healthcare services. As the
population grows and ages there will be more people requiring
healthcare services. As the number of uninsured Americans increases,
more and more of this care is provided without reimbursement. The
overall effect of this increase in demand for healthcare services at
the emergency department and hospital level is to significantly reduce,
and in many facilities eliminate, any surge capacity for response to a
public health emergency, whether it is a pandemic event or a mass
casualty incident.
Every day emergency physicians save lives across America. Emergency
departments provide an essential community service and are the safety
net of medical care in this country. However, emergency departments are
at the breaking point and additional resources and long-term solutions
must be provided before systemic failure eliminates the ability of
emergency physicians to provide care when and where it is needed.
There is a secondary concerning effect of the increase in the
demand being placed on hospitals and emergency departments that is a
reluctance to invest in preparedness activities. As the healthcare
delivery system has become more stressed, both in terms of volume of
services and uncertainty in levels of reimbursement, there is an
increased reluctance to expend financial resources on preparedness
activities, both in support of training and exercises. Although
regulatory demands on hospitals and other healthcare facilities to
prepare for public health emergencies continue to increase, there is no
reimbursement for such activities from private insurers. This puts a
greater demand on funding for preparedness activities to come from
federal or state sources.
Hospitals today operate utilizing just-in-time inventory management
systems, making the delivery of healthcare more cost-effective, but
significantly reducing the on-hand availability of additional materiel
needed to respond to large scale public health emergencies. Again, this
places a greater demand on funding from federal or state sources to
meet this critical need.
Engaging and educating the largest part of the response pyramid.
Given that it is unlikely that there will be adequate stockpiles of
supplies and equipment for an entire pandemic event, it is imperative
that we are able to engage the general public and encourage them to
assume responsibility for their own preparedness. Just as the saying
goes that ``all disasters are local'', so is the response to a
disaster. In the truest sense for a pandemic, this means that
preparedness must begin with individuals, families, neighborhoods, and
communities.
It is this last challenge that is the most difficult, and likely
the most important in ensuring that society at large will remain intact
during a prolonged pandemic event. As the perception of risk of a
pandemic event wanes in the media and general public, the receptiveness
of the public to risk communication related to preparedness also wanes.
It is critical to the successful response to a pandemic event that
we develop a ``culture of preparedness'' in this country, in order to
ensure that those who have the means to prepare for themselves do so.
If we can accomplish this through risk communication and broad-reaching
educational programs, then the burden of response on government will be
reduced so that scarce resources can be shifted to those who are most
at risk.
However, reaching and educating the base of the pyramid takes time.
While those of us directly involved in preparedness activities can
devote the necessary time to incorporate new information and plans
regarding a pandemic or other public health emergency into our working
knowledge, it is not the primary focus of the general public or other
healthcare professionals.
Conclusion
States and our local healthcare partners are willing participants
in the development of systems to respond to a pandemic event or other
public health emergency. While the resources and support of the federal
government is essential to the creating and sustaining the capability
and capacity required to sustain a response to a large scale ongoing
incident like a pandemic event, the coordination of all large scale
public health emergencies will be at the state and local level.
It is important to understand that increased requirements to
deliver training and undertake exercises and drills related to pandemic
event or other public health emergencies require considerable planning
time and utilization of resources in order to be effective. In many
cases, these resources are being stretched very thinly, both at the
state and healthcare facility level. As the requirements for delivery
of more training, drills and exercises increase under federal grant
programs it is critical that all federal preparedness grant programs
related to pandemic influenza or other public health emergency be more
closely aligned and coordinated so that we at the state level can more
effectively develop an appropriate response to whatever public health
emergency may occur.
Mr. Chairman and members of the committee, I thank you for the
opportunity to discuss these important issues with you this morning and
would be happy to answer any questions at this time.
Mr. Langevin. Thank you, Dr. Cirillo.
With that, I want to recognize Dr. Shult to summarize his
statement for 5 minutes.
Welcome.
STATEMENT OF PETER A. SHULT, DIRECTOR, COMMUNICABLE DISEASES
DIVISION, WISCONSIN STATE LABORATORY OF HYGIENE
Mr. Shult. Thank you, Mr. Chairman and members of the
subcommittee. I am here today representing the Association of
Public Health Laboratories, of which the Wisconsin State
Laboratory of Hygiene is a member.
As the name implies, the APHL is the association for state
and local governmental laboratories that perform testing of
public health significance.
In the event of an influenza pandemic, it is currently
highly unlikely that a well-matched vaccine, the best
countermeasure, will be available when a pandemic begins.
Instead, current national plans call for the initiation of
drastic community mitigation measures augmented with
distribution of limited antiviral supplies to impede the
pandemic's progress.
This will require documentation of the emergence of a novel
influenza virus and confirmation of sustained community
transmission of the virus using highly specialized laboratory
testing performed solely by a public health laboratory.
Maintaining this capability and response readiness will be
a challenge for the public health laboratory, given limited and
now declining federal support and a greatly expanded role, well
beyond diagnostic testing, in emergency preparedness and
response.
Public health laboratories are the leaders in laboratory
preparedness and response efforts, key national security assets
that serve as reference laboratories in the National Laboratory
Response Network.
These laboratories are capable of performing highly
advanced, accurate tests that allow rapid detection and
identification of biological agents of public health
significance, including seasonal influenza strains and newly
emergent subtypes of influenza with pandemic potential such as
the H5N1.
This testing capability is critical to state and national
influenza surveillance.
Furthermore, because of the potential introduction of a
novel virus into the United States from international
travelers, CDC now requires that states conduct this
surveillance year-round.
The public health laboratory must also work closely with
private-sector laboratories that provide diagnostic testing to
support patient care, with agriculture and veterinary
laboratories responsible for monitoring influenza within animal
populations, and with a host of other public health and
emergency first responder partners.
Maintaining these networks is resource-intensive and
difficult to accomplish without adequate funding.
The public health laboratories are heavily reliant on the
expertise at CDC--in this case, the CDC's influenza division--
to assist in outbreak response and to develop new methods for
detection of influenza.
The CDC is also critical in helping facilitate
collaboration among laboratory partners to ensure adequate
testing surge capacity is available for pandemic response.
DHS has created the Integrated Consortium of Laboratory
Networks to address coordination and integration of the
different federal level agency networks.
However, the work of the ICLN has not yet been apparent to
the front line public health laboratory serving an all-hazards
mission with diminishing resources.
Traditionally, public health laboratories have relied on
state resources and minimal allotments from the CDC's
epidemiology and laboratory capacity funding to support
laboratory influenza surveillance.
Although further supplemental funding has been appropriated
for pandemic influenza preparedness, to date few public health
laboratories have benefitted from these funds, despite
increased expectations for rapid testing and year-round
surveillance.
Only because of funding from the CDC's public health
emergency preparedness program has substantial laboratory
emergency response infrastructure to respond to bioterrorism,
pandemic influenza and other public health emergencies been
developed. However, this funding has also begun to decline.
In conclusion, given the critical role of the public health
laboratory in detecting and monitoring both seasonal and novel
potentially pandemic strains of influenza, as well as other
potential public health threats, the substantial testing
capabilities and capacities that have been developed and that I
have described in my written testimony need to be sustained.
And future improvements in diagnostic technology and
networking activities, such as communications and information-
and data-sharing among laboratories and with response partners
need to be made.
Without sustained federal funding from CDC and other
agencies, our ability to fulfill this pandemic and all-hazards
public health and national security mission will be
compromised.
I ask your help in not letting this happen. Thank you very
much, and I would be glad to answer any questions.
[The statement of Mr. Shult follows:]
Prepared Statement of Dr. Peter Shult
My name is Dr. Peter Shult and I am here today representing the
Association of Public Health Laboratories, APHL. I am currently the
Director of the Communicable Diseases Division of the Wisconsin State
Laboratory of Hygiene. As its name implies, APHL is the association for
state and local governmental laboratories that perform testing of
public health significance.
Public health agencies worldwide have been tasked with leading
preparedness and response planning efforts necessary to minimize the
impacts of seasonal influenza epidemics as well as the next pandemic.
In the case of pandemic influenza, it is currently highly unlikely that
a well-matched vaccine, the best countermeasure, will be available when
a pandemic begins. In addition, sufficient supplies of influenza
antiviral medications might not be available. Consequently, current
national plans for pandemic response call for attempting to mitigate
the effects of a pandemic early on by relying on strategies for case
containment (isolation and quarantine), social distancing (school
closures and social distancing of adults in the community and at work)
and infection control (hand hygiene, cough etiquette). Initiation of
these rather drastic measures will require documentation of emergence
in the U.S. of a novel influenza A subtype and confirmation of
sustained community transmission of the virus. This will require
laboratory testing; the responsibility for this testing role will rest
with the public health laboratory--state and local governmental
laboratories tasked with supporting their public health jurisdictions
in preparedness and response activities.
Role of the public health laboratory
The public health laboratory is the leader in laboratory
preparedness and response efforts. Public health laboratories, serve as
reference labs in the Laboratory Response Network (LRN). They are a key
national security asset, providing some of the most advanced and rapid
testing available in the LRN. These laboratories are capable of
performing tests to rapidly detect and identify highly dangerous
biological agents. Public health laboratories also have established
linkages with law enforcement, including the FBI, and utilize chain-of-
custody and testing protocols consistent with legal evidentiary
requirements. The state public health laboratory has developed a
culture of emergency response. There is an expectation that we follow
incident command structure, and that we have continuity-of-operations
plans. We coordinate with other first responders, hazardous-materials
teams and law enforcement on a regular basis responding to unknown
threats and suspicious packages. We're emergency responders from the
lab perspective.
The LRN was established to address only those agents that could be
used for biological terrorism (BT). However, since that time, the LRN
has been utilized to address non-terrorism agents as well, an ``all
hazards'' philosophy. At the state level, infrastructure developed as a
result of funding from the Centers for Disease Control and Prevention's
(CDC) Public Health Emergency Preparedness (PHEP) Cooperative
Agreements, like upgrading laboratory facility biosafety levels,
purchasing state-of-the-art molecular detection equipment, and hiring
staff with advanced diagnostics expertise, has significantly improved
the public health laboratory's ability to respond to emerging diseases.
In Wisconsin, we could not have weathered the SARS, monkeypox and mumps
outbreaks of recent years without the resources provided through the
PHEP and LRN. These resources are also helping us improve annual
influenza surveillance using state-of-the-art methods, and prepare for
a potential pandemic. The public health laboratory will be an integral
part of any public health response to pandemic influenza and must be
included in comprehensive local, state or federal plans for
preparedness and response.
Laboratory results are critical for influenza surveillance and for
public health decisions during both routine ``seasonal'' influenza and
during pandemic alerts and pandemic periods. Public health laboratories
contribute significantly to surveillance efforts within each state and
to national surveillance efforts as members of a network of World
Health Organization collaborating laboratories, coordinated in the U.S.
by the CDC. Specifically, public health laboratories provide highly
accurate and rapid testing for confirmation and identification of
``seasonal'' influenza strains as well as newly emergent subtypes of
influenza such as H5N1. This testing incorporates the use of newer
state-of-the-art methods as well as traditional methods that require
growing the virus. Laboratory testing is the only way to attribute
``flu-like'' illness to a specific pathogen, either influenza or one of
the hundreds of other viral respiratory pathogens that circulate each
year.
In addition, during ``seasonal'' influenza, laboratory testing is
critical to:
determine when, where and which strains and subtypes
of influenza viruses are circulating;
monitor the extent and duration of the epidemic;
detect novel influenza subtypes such as H5N1;
optimize the use of vaccines and antivirals including
monitoring for antiviral resistance
Public health laboratories also provide virus samples to CDC for
further characterization throughout ``seasonal'' and pandemic periods,
and this information contributes to the selection of future vaccine
strains. In fact, one of the viruses used to make last year's vaccine
came from the Wisconsin State Laboratory of Hygiene.
Because of the potential introduction of a novel virus into the
U.S. from international travelers, CDC now requires that states conduct
year-round surveillance. Although it has become commonplace these days
to think of planning for a pandemic only in terms of avian flu or more
specifically H5N1, the reality is other avian influenza viruses have
been implicated in human disease (including avian influenza H7N7, H9N2,
H7N2, H7N3). It is essential that current influenza surveillance
programs provide for rapid detection of any novel strain.
While the public health laboratory focus is on surveillance to
support response and control measures, they must also work closely with
private sector laboratories that provide diagnostic testing to support
clinician diagnosis and treatment of their patients. Public health
laboratories provide confirmatory testing for clinical laboratories,
education to clinicians and clinical labs regarding the use and
interpretation of rapid influenza tests, and guidance for handling and
submission of suspect pandemic strains from clinical and physician
office laboratories. These are resource intense activities that are
difficult to maintain without funding.
During the early stages and throughout a pandemic, additional goals
for diagnostic testing at public health laboratories will include:
detecting and confirming initial cases of pandemic
influenza in communities and confirming that sustained person-
to-person transmission has occurred to initiate targeted
community-level interventions including containment (isolation
and quarantine), social distancing strategies and infection
control;
differentiate patients with pandemic influenza from
those infected with the ``seasonal'' strain or other
respiratory viruses;
monitor the pandemic's geographic and regional spread
through laboratory testing;
measure the impact of interventions such as
vaccination, antiviral therapy, and non-pharmacologic
interventions; and
monitor the pandemic strain to determine the
effectiveness of any vaccine (when available and the mergence
of antiviral resistance
In addition to these direct response roles, we provide the
diagnostic expertise in the development of pandemic preparedness and
response plans and their exercise within states, and provide faculty
and expertise to support CDC laboratory training efforts domestically
and internationally. Public health laboratories also maintain a close
working relationship with agricultural and veterinary diagnostic
laboratories to monitor influenza activity within animal populations
that may impact human populations.
While state public health laboratories have significant expertise
in infectious disease testing, we heavily rely on the expertise at CDC
to assist in outbreaks, and develop new methods for detection of
emerging pathogens that can rapidly be deployed to our laboratories.
CDC's influenza division has developed the advanced detection tools
currently available in public health laboratories to detect and subtype
the influenza A virus, to monitor seasonal circulating strains and
detect novel viruses strains. Beginning in 2003, CDC has provided
protocols and training for state public health laboratories to perform
real-time RT-PCR for molecular detection of Influenza A & B viruses,
and for subtyping Influenza A H1, H3, H5 and H7 subtypes. The currently
circulating H5N1 strains have been undergoing rapid evolution, so it is
essential that CDC continue to carefully monitor the performance of the
real-time RT-PCR assays currently in use in public health laboratories
by testing H5 samples received from other countries.
The CDC is also working with APHL and other partners on other
critical issues related to pandemic influenza response. I have no doubt
with the first emergence of a pandemic influenza strain--particularly
if it happens to be H5N1--there will be a panic with consequent
pressure on public health, including the laboratory, to respond
immediately. How much laboratory capacity will be needed for
surveillance and diagnostic support during the early stages of a
perceived or real influenza pandemic affecting the U.S.? What is the
best way for public health and private sector laboratories to
collaborate and support any surge in testing needs? There will, no
doubt, be a need for other surge capacities to ensure adequate
materials and supplies for diagnostic testing and enhanced
transportation mechanisms to move these goods and supplies as well as
patient specimens to the laboratories.
It is important to point out that currently there exist no
stockpiles of critical laboratory supplies and materials analogous to
those developed for pharmaceuticals and other critical emergency
response supplies. This could prove to be a critical shortfall! These
questions and issues are currently being addressed through an APHL/CDC
clinical laboratory partner's workgroup. From a public health
perspective, it is assumed that as the pandemic peaks, every ill
patient will not need laboratory testing. However, the demand for
testing from patients and doctors will rapidly outstrip testing
capacities. These are critical issues that must be addressed pre-
pandemic. APHL is also working with CDC to develop guidance on the use
of various diagnostic tests from the introduction of the novel strain,
through the peak of the pandemic, and into the recovery period.
Resources to support the public health laboratory
Traditionally public health laboratories have relied on state
resources and the CDC's Epidemiology and Laboratory Capacity (ELC)
funding to support laboratory influenza surveillance. In 2006, ELC
provided $2.2 million to support epidemiology and laboratory activities
for seasonal influenza surveillance across 50 states. Although
supplemental funding has been appropriated for pandemic influenza
preparedness, to date many public health laboratories have not
benefited from these funds, despite increased expectations for rapid
testing and year-round surveillance.
Substantial state public health laboratory capability and capacity
to respond to bioterrorism, pandemic influenza and other public health
emergencies has been developed in States over the last several years
with the help of other federal funding sources. The degree to which
this has been accomplished is related to the distribution of this
funding to public health laboratories which has been highly variable on
a state-by-state basis both in terms of the type and amount of funding
received and the period of time over which it was received.
In general, Public Health Emergency Preparedness (PHEP) funding
from the CDC has supported laboratories' efforts to:
build state-of-the-art diagnostic capability and
capacity for rapid and accurate laboratory diagnosis of primary
agents of bioterrorism (BT) and other major public health
threats such as SARS and pandemic influenza as a Laboratory
Response Network Reference laboratory.
develop state-based networks of clinical laboratories,
and provide them with emergency response and specimen shipping
guidelines and protocols, 24/7/365 state courier systems to
ensure rapid transport of specimens, emergency messaging and
electronic data sharing capabilities, training in diagnostic
testing to recognize and rule-out the presence of priority
bioterrorism agents or other agents of public health
importance.
develop and support training programs for Hazardous
Material teams to improve coordinated response to hazardous
materials incidents involving ``white powders'' and other
unknown substances,
to support preparedness and response planning and
develop emergency response protocols with other response
partners including state food testing and veterinary diagnostic
laboratories,) and Federal (CDC, FBI, USPS) response agencies.
The outcome of these efforts in Wisconsin and other states can be
measured in part by the significant role the public health laboratory,
with these enhanced capabilities and capacities, and the clinical
laboratory networks, with whom they collaborate closely, played in a
number of recent, high profile outbreaks including SARS (2003),
Monkeypox (2003), pertussis (2003-06), mumps (2006), norovirus (2006-
07) and the E.coli O157:H7 spinach outbreak (2006) to name but a few.
In addition to responding to bioterrorism, pandemic influenza and
other public health threats, public health laboratories are serving an
all-hazards mission, providing environmental testing for bioterrorism
and chemical terrorism agents, participating in the Food Emergency
Response Network sponsored by FDA and USDA, and responding, sometimes
daily, to a host of unknown threat emergencies. DHS has created the
Integrated Consortium of Laboratory Networks to address coordination
and integration of the networks at the Federal level. The ICLN is
charged with assuring coordination across the networks. The work of the
ICLN has not yet been apparent to the front-line public health
laboratory serving an all-hazards mission with diminishing resources.
In Wisconsin and in many other states, substantial laboratory
emergency response capability, capacity and infrastructure has been
developed. But this is only the beginning of addressing laboratory
needs; what has been built needs to be sustained and this is where the
greatest problem may lie.
Maintenance of what has been built in terms of emergency laboratory
response capability much less continuous future improvements in
diagnostic technology, information and data sharing, etc. now may be in
jeopardy.
Despite the ongoing threat of pandemic influenza and
in the face of numerous infectious disease outbreaks many state
and local public health laboratories have suffered recent
substantial cuts in funding. In Wisconsin, fiscal year 2007
PHEP funding to the public health laboratory was cut by nearly
60% and this cut will be carried over to fiscal year 2008. ELC
funding to the Wisconsin public health laboratory also has
dropped substantially over the past 5 years.
A number of state public health laboratories did not
receive any ELC or Pandemic Influenza Supplemental funding and
received substantially less PHEP funding than Wisconsin because
these funds were not allocated to them by their states. Further
cuts to these public health laboratories would be devastating.
Costs (salaries, diagnostic equipment maintenance,
materials, etc.) to maintain this laboratory response
infrastructure are significant and, in fact, are increasing and
will continue to do so.
Direct state support of these emergency laboratory
response efforts is variable and in many cases non-existent
(this is the case in Wisconsin). This forces the laboratory to
have to re-allocate their state funding allotment or perhaps
collected fees to emergency preparedness and response at the
expense of other laboratory activities that may still have
public health importance.
The clinical laboratories, who will be on the front
line in response to public health emergencies such as pandemic
influenza and bioterrorism and with whom the state public
health laboratories have formed critical partnerships are now
highly dependent on the public health laboratory for reference
and confirmatory testing, training, communications and data
sharing, emergency response guidance, etc. And the fact is, in
many circumstances, the public health laboratory may not be
able to mount an effective laboratory response to a public
health emergency without their clinical lab partners.
Federal funding must continue to sustain the laboratory capability
and capacity necessary to effectively support the public health
response to pandemic influenza, bioterrorism and other public health
threats, and the expanding all-hazards mission. What will be the
outcome if funding of these laboratory efforts continues to diminish or
is eliminated altogether?
Diagnostic capability and laboratory technical
expertise needed to respond to current and future threats
within the state public health laboratory, the nation's LRN
reference laboratories, will not be maintained.
Adequate staffing levels of diagnostic and support
personnel will not be maintained. This is a particularly bad
outcome in terms of surge capacity needed during an influenza
pandemic when perhaps 30% or more of the workforce may be
incapacitated at various points of time during the pandemic.
The ability to bring online the newest diagnostic
technologies needed for response to current and future
infectious disease threats will be severely diminished.
The ability to sustain the highly effective network of
LRN Sentinel clinical, LRN reference public health and other
laboratories (food testing, veterinary), the very backbone of
the LRN, will be lost.
Training of clinical laboratorians in diagnostic
procedure to support public health emergency response will
cease to be available through the public health laboratory, the
current major provider of such training.
Conclusion
In conclusion, the public health laboratory likely will be a
critical component of the trigger that initiates the pandemic response
plan and community mitigation strategies. The ability to confirm that a
patient is infected with a novel strain of influenza resides solely in
public health laboratories. Public health laboratories must be prepared
to provide crucial influenza diagnostic and surveillance services to
quickly detect and monitor the progression of a novel virus and provide
testing to support ongoing response decisions. Pandemic influenza
preparedness plans depend upon the public health laboratory delivering
effective and coordinated diagnostic services, results, and
communication. Epidemiologic surveillance programs that monitor for
pandemic influenza rely heavily on accurate laboratory testing and,
therefore, must have timely information. Furthermore, in the event of
pandemic influenza, the appropriate use of antivirals and vaccination
can only be accomplished with public health laboratory support. Public
health laboratories are now called upon to fulfill a pandemic and all-
hazards public health and national security mission. Without sustained
federal funding from CDC and other agencies, our ability to respond to
the increasing number of potential threats will be compromised.
Appendix-Influenza Primer
Influenza is a major public health concern in the U.S. as well as
globally. Two types of influenza, A and B, are responsible each year
for seasonal epidemics that affect 5--20% of the population causing
significant illness with resultant lost time from work and school
across all ages. The highest rates of illness occur in the very young
often resulting in severe illness and hospitalization. Young pre-school
and school-aged children are also responsible for initial transmission
of influenza in the community. The elderly, particularly those over the
age of 65 also suffer high rates of hospitalization and a
disproportionate percent (90%) of the mortality which totals over 35,
000 each year in the U.S. This morbidity and mortality occurs despite
the availability of effective prophylaxis (vaccine) and treatment
(antivirals) measures
In recent years, avian influenza, so-called ``bird flu'' also has
become a major concern. Aquatic bird species world-wide serve as the
natural host for all of the subtypes of type A influenza known. Usually
these viruses cause little or no illness in their natural host.
Occasionally, however, certain subtypes mutate and become capable of
causing severe illness with very high mortality, particularly within
domestic poultry populations. These novel subtypes can also become
capable of infecting humans resulting in very severe disease with high
mortality. This is the situation that has been unfolding in the Far and
Middle East, countries of Africa and Europe with the emergence of the
H5N1 subtype of influenza since 2003. Since then, this virus has been
responsible for the direct death or slaughter of hundreds of millions
of poultry in affected countries. In addition, 328 human cases with 200
deaths have been documented in 12 countries. Almost all of these human
cases, mostly children and young adults, have resulted from direct
contact with infected poultry; there is no evidence thus far of
sustained human-to-human transmission. Should sustained human-to human
transmission of this or another novel subtype of influenza A occur, the
result would likely be a worldwide epidemic, or pandemic of influenza.
During the past century, 3 influenza pandemics occurred with the
biggest occurring in 1918-1919. This Great Influenza Pandemic or
Spanish Influenza Pandemic as it was called was responsible for over
20million deaths worldwide and over 500,000 deaths in the U.S. while
infecting an estimated 45% of the entire global population. The two
subsequent pandemics in 1957 (``Asian influenza'') and 1968 (``Hong
Kong influenza''), although milder in terms of morbidity and mortality,
nevertheless had profound impacts on the global population.
Most experts feel that another pandemic is inevitable and many feel
that we are now overdue. With today's much greater population and
global interconnectivity even a mild to moderate pandemic, similar to
the last two, occurring as multiple waves over a period of two years or
longer, would rapidly affect the world with rates of infection of up to
50%, mortality measured in the millions (100,000s in the U.S.) and
severe social, infrastructure and economic disruptions.
Mr. Langevin. Thank you, Dr. Shult. I appreciate your
testimony.
And the chair now recognizes Dr. Caldwell to summarize his
statement for 5 minutes.
Welcome.
STATEMENT OF MICHAEL CALDWELL, MD, MPH, COMMISSIONER, DUTCHESS
COUNTY HEALTH DEPARTMENT, POUGHKEEPSIE, NEW YORK
Dr. Caldwell. Good afternoon, Chairman Langevin,
Representative McCaul. It is a pleasure to be here to speak to
you on behalf of all the local departments of health in our
country.
I come from Dutchess County, New York, the place and the
home of Franklin and Eleanor Roosevelt, so greetings from
there, and please, if you do come to visit, please let me know.
You know, Franklin Roosevelt won the presidency four times.
Did you know that his home town of Hyde Park in the county of
Dutchess never voted for him? Never. It was sad for Franklin.
And I tell you, it is kind of a microcosm of what it is
like doing public health in Dutchess County. It is a challenge.
We have a challenge in our county and we have a challenge in
our country.
The combined efforts of my colleagues in local public
health departments in first response will determine the initial
as well as the ultimate impact of an influenza pandemic on the
people of the United States.
Health departments are planning, but the success of those
plans relies on the crucial linkages that have been built
between our local public health departments and a range of
governmental and community partners at the local level,
including also the state and the federal level.
The relationships among these responders in many
disciplines across our commissions, regardless of who their
federal counterparts may be--they are growing more robust. They
are better coordinated.
And I really want to answer your question that you asked,
very simply, are we more prepared, and the answer is, yes.
Today I bring you a story of progress, a story of success at
the local level, but clearly an opportunity to improve, and an
opportunity that I think needs to be led and demonstrate the
leadership at our federal level.
There is no question that local emergency preparedness has
evolved into an all-hazards approach right now. It requires
communities to assure that all capabilities are necessary to
respond to a wide range of emergencies.
Our health departments do not and cannot stand alone. All
of our planning must be integrated with all of our partners and
first responders. And one of the great advances we have had is
the strength and mandate of the National Incident Management
System, the Incident Command System.
Just this past week, I spent 3 full days in Poughkeepsie,
New York completing the ICS-300 training with colleagues from
emergency response--police, fire, EMS, water plant operators,
state emergency management officials, state troopers, public
health nurses. We really have made progress in that area.
In Dutchess County, we have learned this new language and
we have put it into effect.
But more really needs to be done. We need to strengthen
these opportunities. We need to strengthen this planning. And
we also need to exercise and evaluate.
It is very important to know that the greatest strength
that we provide at the local level is the strength of our
American workforce.
Our astute clinicians and the partnerships that we have
with our colleagues, our trained health care professionals, our
alert hospitals--these effective partners are forged between
these entities and our capable colleagues in local public
health.
Ultimately, the local public health departments are the
boots on the ground element of our nation's disease system. My
health department receives and responds to thousands of
infectious disease reports each year.
After September 11th, our county's hospitals and emergency
departments began reporting on our hospital emergency response
data system.
We also have partnerships not only with our health care
providers but veterinarians and pharmacists. Soon we will be
also reaching out not only to schools and school nurses but
colleges and businesses.
We are actively engaged in cross training our entire
community to be aware and be prepared.
We are also providing and improving our community alert
network, our reverse 911 system of communication. We think that
is one of our major roles and something that we are working
hard to improve.
Ultimately, we believe that we need a strategy of
implementation, not just planning. And the implementation
happens at our level. We need the resources. We need the
people. We need to exercise and evaluate. And we need to
improve. We need sustainable and a growing commitment from the
federal government.
Unfortunately, we have seen mixed messages from our federal
leadership. There does not appear to be adequate coordination
or cooperation between the planners of Health and Human
Services and the Department of Homeland Security.
We have seen clear examples of us being left out of the
development of the national response plan.
It makes no sense to develop a plan among federal officials
and then just tell the local officials how it is going to work
without integrating them and involving them in the first place,
and also including in the development of those plans the
understanding of how it is going to be implemented and carried
out.
We are hopeful that the federal colleagues of ours will
hear this message, and as we improve the future planning and
the future versions of these plans, we will be able to get
feedback from our testing.
And we are going to learn nothing unless we exercise and
test our plans and constantly revise them.
So we are hopeful today by you having this hearing. We want
to thank you for the recognition that we have made progress,
that we need to do better. We need to continue our
conversation.
And we look to the federal government to be able to serve
as an example to us at the local level. If we see that there is
miscommunication and miscoordination at the federal level, that
impacts us at the local level and makes our jobs more
difficult.
If my emergency response department and my health
department have different planning tools, it makes it more
difficult for us to integrate those tools.
Overall, our community and families depend on us for
leadership. They depend on us for competency, for guidance, but
most importantly, for action. We should not and we cannot let
them down.
Public health preparedness is a long-term challenge,
whether it is for pandemic influenza or any other emergency. We
obviously cannot do everything at once, but we are making great
strides. I am pleased with it.
And I want you to know that local public health departments
are integral in both the planning as well as the execution of
any pandemic influenza efforts. Thank you very much.
[The statement of Dr. Caldwell follows:]
Prepared Statement of Michael D. Caldwell, MD, MPH
Good Morning Chairman Langevin, Representative McCaul, and
distinguished Members of the Committee. It is my pleasure to address
you today on behalf of the nation's 2800 local public health
departments, who work on the front lines to protect their communities
from pandemic influenza, as well as a multitude of other public health
threats. I am a Past President of the National Association of County
and City Health Officials and I have had an opportunity to learn from
my colleagues across the country. I have had the privilege of
representing our local public health departments by participation in
focus groups for the development of standards for Fusion Centers to
capture, coordinate, and rapidly communicate intelligence among all
levels of government. In my home County of Dutchess in New York, I have
been deeply engaged in pandemic influenza preparations under the
leadership of our County Executive William R. Steinhaus. Today, I am
happy to report to you on the progress made by local health departments
and their community partners. I will also point out areas of concern
that we have identified as shortfalls in current national pandemic
influenza preparedness.
The combined efforts of local health departments and our colleagues
in first response will determine the initial, as well as the ultimate
impact of an influenza pandemic on the people of the United States. I
will describe how local health departments are planning our response to
a worldwide influenza outbreak, with an emphasis on how the success of
those plans relies on the crucial linkages that have been built between
local public health departments and a range of governmental and
community partners. Relationships among responders in many disciplines
and sectors across our local communities, regardless of who their
federal counterparts may be, are growing more robust and better
coordinated. If we are to protect our communities adequately, we have
no choice but to reach out, engage, communicate and cooperate with our
local partners.
Pandemic Influenza Preparedness Must be Integrated into All-Hazards
Preparedness
Local emergency preparedness is based on an `all-hazards' approach.
This approach requires communities to assure the essential capabilities
necessary to respond to a wide range of emergencies: intentional or
naturally occurring infectious disease outbreaks; chemical, explosive
or radiologic accident or attack; weather-related disaster; or other
emergency.
Since 2001, with the elevated awareness of the country's
vulnerability to intentional attacks with biological agents, there has
developed a better understanding of public health's unique role in
protecting our homeland. Whether the communicable disease threat is a
novel influenza virus, smallpox, anthrax, West Nile Virus, SARS, or
other emerging pathogen capable of causing widespread illness and
death, there is a core of universal public health response capabilities
for which all local health departments across the country are planning,
training, exercising and engaging in a process of continuous evaluation
and improvement.
However, our local health departments do not and cannot stand
alone. All planning and response is and must be integrated with other
local entities, most notably public safety first responders, but also
state, federal and non-governmental partners. Fundamental to such
integration is a shared command and management framework. With its
strong foundation in the Incident Command System (ICS), the broader
National Incident Management System (NIMS) developed under Homeland
Security Presidential Directive 5 provides this common underpinning for
all public health and public safety preparedness. Adoption of NIMS is
facilitating the integration of language, mental models and even
certain cultural aspects of public safety by public health
professionals.
Just this past week, I spent three full days in Poughkeepsie, NY
completing the ICS-300 training with colleague emergency response
partners which included local police, fire, EMS, water-plant operators,
state emergency management officials, state troopers, public health
nurses and many other disciplines mandated to be trained. These
mandates, while burdensome, provide many important benefits, including
opportunities to meet and work with the very individuals who we will
likely meet in the Emergency Operations Center (EOC) during a real
emergency. I have always said that the EOC should be the last place for
exchanging business cards of introduction with your critical partners.
In Dutchess County, the staff of our health department have learned
this new language and approach. They have grown accustomed to planning
and exercising within an incident command system. We practice this in
many ways. For instance, we use incident command for our seasonal
influenza vaccination clinics, so that we will know exactly how to
address a need for mass vaccination. We have worked closely with the
local police to address traffic and safety issues in planning our
system of PODS, or points of mass distribution sites, which we would
need to distribute medication during a pandemic or other public health
emergency.
Through these opportunities to strengthen relationships, our county
emergency management agency now understands and uses the expertise that
our health department offers in epidemiologic surveillance,
environmental health, and medicine. We work side-by-side on planning,
education and evaluation. The health department is now included in
emergency drills undertaken by other county agencies and organizations.
This enables us to uncover and address discrepancies between the
emergency plans of individual organizations, so that the expectations
of every responding agency are universally understood.
Key Elements of Front Line Pandemic Influenza Preparedness
1. DISEASE SURVEILLANCE
The purpose of a strong surveillance system is to create time in
which to intervene and to eliminate or mitigate threats. In local
public health, practical disease surveillance means a system by which
clinicians in private practice or in hospital settings can detect and
report a novel flu virus or a patient who is suspected to have a
reportable disease or an unusual case presentation to a public health
authority capable of receiving, interpreting and responding to such a
report. Ultimately, the country may reach a point where electronic
medical records and associated systems will enable automatic reporting
of diseases or suspicious symptoms, but such capability will be
immensely challenging in this intensely diverse and complex national
environment. We cannot wait, nor can we depend solely on technology
when so much is at stake.
Our greatest strength is in our American workforce--our astute
clinicians, our trained healthcare professionals, our alert hospitals--
and the effective partnerships that are forged between these entities
and capable local public health departments. It is important not to
underestimate the immediate and important utility of this model of
disease surveillance. As we recently witnessed with the case of the
mismanagement of the internationally traveling groom with multi-drug
resistant tuberculosis, all electronic monitoring efforts can be
thwarted by just one human error. All of our new multi-billion dollar
monitoring systems must be complemented with continued vigilance,
training, testing and evaluation of our front line agencies and their
workers.
Local health departments are the `boots on the ground' elements of
our nation's disease surveillance system. My health department receives
and responds to thousands of infectious disease reports each year. In
preparation for pandemic influenza, we have determined that syndromic
surveillance must accompany traditional methods of case reporting.
Syndromic surveillance will allow prompt identification of potential
communicable disease clusters and trigger response long before
laboratory confirmation is received.
After 9/11, our county hospitals' emergency departments began
reporting individual patient's symptomatology to the state and local
health departments via the HERDS (Hospital Emergency Response Data
System) data base. In addition to this statewide effort, our local
health department makes direct phone contact daily with each emergency
room to identify clusters of illness or unusual presentations. This
ongoing networking effort with local emergency departments and
infection control staff has proved to be crucial in the early
identification and response to infectious disease. We have also
partnered with select community health care providers and veterinarians
to function as sentinel sites for syndrome and emergent infectious
disease identification.
Our most recent effort for improving our surveillance capacity is
to work with schools, particularly school nurses. We are training them
in the basic principles of epidemiology and disease surveillance and
asking them to report absences due to sickness to us more frequently.
It is our intention to expand these syndromic surveillance efforts to
local colleges and major businesses soon. We are actively engaged in
cross-training the majority of environmental sanitarians and public
health nurses in the basics of outbreak response so they can assist in
case investigation, contact tracing and outbreak control efforts should
a large scale event occur.
2. COMMUNITY AWARENESS & SELF-SUFFICIENCY
One thing that we understand about a pandemic is that there will
never be enough hospital beds to take care of the sick. We can predict
that we will be asking both the sick and the well to stay home to help
stem the spread of pandemic influenza. But we also know that our
community needs early education, rapid communication and preparation so
they will understand this if a serious epidemic occurs. Therefore, in
Dutchess County we are placing a great emphasis on community education
and have reached out to the schools, the business community, law
enforcement, emergency services and home care agencies. Reaching every
Dutchess resident in a meaningful fashion is a huge task. We can't do
it all at once, but we work at it consistently because we believe that
community understanding and cooperation will be absolutely essential in
reducing the toll of a pandemic.
Our county's home care agencies are developing a unified emergency
preparedness home care plan. This will enable our residents to know
that there will be people available to deliver some medical and nursing
care in their homes if they get sick.
There is a tremendous desire for information regarding pandemic
influenza across all sectors and a there is a great deal of work ahead
for local health departments in spreading the word. This effort will be
worth the return if we can reduce panic and increase creative response
options when the need arises, which it will.
3. COMMUNITY INFECTION CONTROL
Over the past several years, the legal foundation required for
public health to adequately protect the public in a catastrophic health
emergency has been significantly strengthened in many states. Both
state and local health departments have closely examined our respective
responsibilities to isolate and/or quarantine persons, to control
private property, or otherwise to intervene in private activities. All
these would be unprecedented actions, requiring enormous pre-planning.
Our health department has worked with the County Attorney's office
to educate legal, law enforcement, and emergency medical professionals
about isolation and quarantine. We also conducted a ``tabletop''
exercise to test our knowledge and we will be continuing to follow-up
on these efforts.
4. MASS DISTRIBUTION OF VACCINES AND MEDICATIONS
Timely development of an effective vaccine, in sufficient quantity
to immunize the population against a novel virus, is a huge challenge
that the Federal government has taken important steps to confront.
Local health departments are responsible on the ground for accepting
delivery of the Strategic National Stockpile in which such a vaccine or
anti-viral medications would be stored. Mindful that we do not now have
the ability to manufacture sufficient quantities of such
countermeasures, we must still have in place all of the planning,
staffing and public information systems necessary to promptly
distribute them to all priority populations in the county.
While we've not experienced a pandemic flu, local health
departments have had parallel experiences and exercises that have
tested our ability to provide mass vaccine and medication distribution.
During the 2004 seasonal flu vaccine shortage, with delayed shipments
causing the public to become extremely anxious to get their flu shots,
our department gave 5800 doses in two days to our most vulnerable
populations. (Dutchess County has a population of 300,000.)
Yet again, we could not have managed this mobilization without the
full support of our public safety partners, who provided security,
traffic control and emergency medical care. These are no minor feats in
a mass setting, especially in a real life situation where emotions are
running high and the chance of panic is never far away. The public
already has benefited greatly from the collaboration between public
health and public safety agencies. Only through a highly coordinated
and very broad approach will we achieve maximum homeland security in
the face of an influenza pandemic.
Another example of the ongoing efforts to enhance inclusiveness and
communications between agencies is that I was invited and am now a
member of our Dutchess County Chiefs of Police Association. When I
entered public health school and when I began my position as
Commissioner of Health back in 1994, I could not have imagined being a
member of the Chiefs of Police Association. Times have changed and so
have our thinking and response to new and emerging threats.
People are Key to Preparedness
Prior to 9/11, many local health departments were open only during
conventional business hours. Unlike fire or police departments, there
was no tradition, structure, or funding for operating 24/7. That has
changed. Now we all have 24/7 coverage and an ability to call out our
staff regardless of the hour. But we do it mostly by increasing
expectations for existing staff. In Dutchess County, we have
established two new positions for public health preparedness. We have
no large cadre of new staff. However, our entire health department
staff, from the clerical staff to the Commissioner, have received and
will continue to receive training in the ICS system.
One characteristic of all the operational capacities needed for
effective pandemic influenza planning I have described above is that
they are labor-intensive. While we do need to make certain capital
purchases in public health, such as communication equipment and
personal protective gear, the bulk of our costs are for people. It is
people who do the collaborative planning in the county and work closely
with their state counterparts. It is people who learn new skills for
their new roles in preparedness. It is people who educate the
community. It is people who reach out to hospitals, businesses,
schools, and all the non-governmental organizations whose help we need
to prepare our communities for a pandemic.
The structure and funding of the nation's pandemic influenza
preparedness efforts simply do not recognize this reality. A NACCHO
survey showed that the average grant received by local health
departments nationally for all-hazards preparedness declined by 20%
from fiscal year 2005 to fiscal year 2006. Supplemental federal funds
for state and local health department work specifically in pandemic
influenza preparedness will terminate in August 2008. We are deeply
worried that, as federal priorities change, our ability to sustain the
workforce that must continue the complex job of preparedness will
diminish. Our local funding for all-hazards public health preparedness
has been eroding steadily.
Federal Leadership
It is a positive step that so many in this country are paying
attention to pandemic influenza before we find that threat a reality.
We often tend to focus on the last event, but in this case the focus
has been on being proactive--a fact which is evidenced by the very
existence of this hearing. Your leadership on this issue is
appreciated.
However, there doesn't always appear to be cooperation and
coordination between preparedness planners at the Federal level and
those working at the local and state levels. In addition, the
Department of Homeland Security (DHS) has made progress in
understanding and integrating public health in fits and starts. Initial
efforts toward fulfilling HSPD-8 showed limited understanding of what
public health even was and how it would mount a response in an
incident. As I described above, pandemic influenza response will
require much more than medical care and hospital beds.
NACCHO has long been concerned that DHS planners, unlike their
state and local counterparts, have little appreciation for the local
public health role in pandemic influenza response and for the kinds of
local operational realities I have described above. The vast assortment
of DHS committees and task forces have only a smattering of public
health representation and the opportunities for meaningful input have
been scant. We respectfully suggest that, while including
representation from the Department of Health and Human Services in DHS
work is important, it is not an effective substitute for gaining the
input of public health departments who are doing the operational
planning every day.
For example, we share the frustration of many local and state
officials about their lack of representation in the revision process
for the National Response Plan (NRP), which will govern response to
pandemic influenza, as well as all other national emergencies. DHS
tasked 12 workgroups to focus on specific issue areas of the NRP. One
of these workgroups focused on 'State and Local Roles and
Responsibilities,'' but had only six state government representatives
and no local government representatives, compared to a group of
approximately 40 federal representatives. None of the state
representatives were public health officials. If DHS intends the new
National Response Framework to address pandemic influenza effectively,
local and state governmental public health experts should be engaged at
the beginning, not during a comment period at the very end.
The input of local responders in public health and every other
discipline of public safety must be brought to bear on DHS plans and
guidance in a manner that enables serious listening and timely input.
That is the only way to bridge the federal gulf between traditional
emergency response and public health emergency response. At the local
level, we believe that public health and its public safety partners
understand the true meaning of ``all-hazards'' preparedness, as well as
the special place that pandemic influenza planning has within that
context. We strongly urge improvements in this regard at the federal
level.
Federal agencies need to collaborate in sending coordinated and
reinforcing messages to all grantees at state and local levels that
multidisciplinary cooperation is a high priority. Through the structure
of grant programs and the guidance provided, DHS and HHS can either
facilitate local efforts in that regard or hinder them with
inconsistent guidance. HHS guidance for public health emergency
preparedness has been incorporating many dimensions of the NRP, such as
required training in the National Incident Management System. In
general, however, federal agencies are developing and disseminating
uncoordinated, fragmented, and dissimilar plans for addressing pandemic
influenza.
Finally, while much time is spent asking local and state emergency
personnel to understand how the national response plan is structured,
we need to remember that no matter how serious the emergency, the
response always begins locally. And in the case of pandemic influenza,
the effectiveness of that early response will determine how the
emergency unfolds. Standardization is important to the extent that it
can be realized, but national plans also must support a response in
every corner of this diverse country. A top-down, one-size-fits-all
approach simply will not be successful.
Whether pandemic influenza or some other disaster afflicts our
nation, there is no shortage of dedicated Americans at every level of
government working hard on homeland security. Continuing to promote,
support, and build local partnerships among public health, health care,
public safety, emergency management, and a host of private sector
partners will only improve our ability to protect the health and safety
of our communities.
Thank you, on behalf of all the nation's local health departments,
for your concern and leadership.
Mr. Langevin. Thank you, Dr. Caldwell.
Before I go to Dr. Lakey, there is a vote on right now. My
intention is to go to Dr. Lakey for your statement and then we
will recess for about 20 minutes, come back for a very brief
round of questions and then conclude.
With that, I recognize Dr. Lakey for the purpose of
summarizing his statement for 5 minutes.
STATEMENT OF DAVID LAKEY, MD, COMMISSIONER, TEXAS DEPARTMENT OF
STATE HEALTH SERVICES, CENTER FOR CONSUMER AND EXTERNAL AFFAIRS
Dr. Lakey. Good morning, Chairman and members. My name is
David Lakey, and I am the commissioner of the Texas Department
of State Health Services.
And I want to thank you for this opportunity to testify on
the progress and the challenges we face in Texas preparing for
pandemic influenza.
In order to understand these, you have to understand
something about the Texas structure. The governor's department
or division of emergency directs overall disaster response in
the state of Texas.
Department of State Health Services, however, is the
primary agency for coordinating health and medical preparedness
and for coordination of pandemic flu prevention, detection,
response and recovery.
We have significant experience in Texas in disaster
response. However, pandemic influenza response is unique, as
has been outlined here earlier today.
There are issues related to the geographical spread. There
are issues related to the length and duration of the pandemic.
And thus, pandemic influenza is not just a medical issue. It is
a societal issue as we respond.
One of the strategies in public health to respond--one of
the cornerstones is called social distancing, basically keeping
individuals apart so they do not spread the disease one to
another.
And this includes closing schools, canceling public events,
working from home--and these are hard decisions. These
decisions are made locally, and we have to work as a state with
our local partners to make sure that there is continuity in how
these decisions are made.
We also have to address worker safety issues to make sure
that the first responders are safe when they respond to
individuals with influenza, so they do not become the next
victims.
We also are struggling with how do we continue our
operations to make sure we have continuity of operation plans.
In a situation where you have 30 percent or 40 percent of
workers absent, how do we continue to keep government
functional, businesses functional, utilities that are being
provided?
We also have to look at hospital surge capacity, especially
intensive care surge capacity. This will be a major stress on
the hospital system and the medical system during a pandemic.
Thus, with that background, we have been working for
several years now on how do we respond as a state to this
threat. And we have done this in collaboration with many
stakeholders, our local partners, our federal partners, so that
we can develop comprehensive plans in the state of Texas for
disaster response.
This is a part of the overall state disaster preparedness
plan, and we have also developed a more comprehensive 122-page
guideline for pandemic influenza that outlines what we
specifically need to do in each stage of the pandemic.
We have worked to make sure that we can allocate and
distribute the antivirals if they are available. We have worked
to make sure that we can vaccinate individuals very rapidly, as
was discussed earlier today.
And we have made sure that we have set up a statewide
laboratory diagnostic system, part of the Laboratory Response
Network that was discussed just a minute ago, so that we can
rapidly diagnose individuals with influenza in a matter of
about 3 hours after the samples are sent to the system of 10
labs across the state of Texas.
We have also provided guidelines to the local health
departments so that it is an integrated response in Texas and
have developed information tool kits for health care providers
and community leaders.
A couple other projects we have been working on this summer
have been the development, working with the CDC, to look at our
laws in the state of Texas to make sure we do have the right
legal infrastructure during a pandemic.
And we have been working with state agencies across Texas
to make sure that there are continuity of operation plans in
all agencies in state government and that there is some
consistency in H.R. policies throughout state government when a
pandemic occurs.
We believe that there are really three critical components
of a strong response to pandemic influenza. First, we need to
build and maintain a strong public health system. This is
locally, at the state and at the federal level.
We need to create partnerships between the federal, state
and local level and international partners and private partners
in this response.
And we need to recognize that there are differences between
local areas and maintain the flexibility that allows states and
localities to act effectively and efficiently during this
threat.
It can't be overemphasized, the importance of a strong
public health system. Texas' success has been due to building
on the public health system and using an all-hazards approach
for all types of threats, so we can identify them, monitor
them, ensure that we can respond effectively, and that we
communicate with our public and our private partners during
this time period.
A couple of examples of the strengths that have occurred in
Texas include the development of our Strategic National
Stockpile Operations Plan. That has been reviewed by the CDC
and it received a very high score this last month.
Our plans have had favorable recognition by the CDC. We
learned during Katrina and Rita the need for a multiagency
coordinating center during any type of disaster where we bring
the individuals that need to take care of the logistic
components of ICS, Incident Command System, together, all
incident command systems, so we can have a coordinated
response.
We have established a surveillance system for all viruses,
respiratory viruses, so we can identify them early. And we have
been coordinating with our CDC partners and other partners at
the border ports of entry and at major airports.
And finally, we have developed a public health information
network so we can disseminate information quickly to our
partners throughout the state of Texas.
And again, it is important to have a very strong public
health response. It is also important to have federal, state
and local partnerships. This is not something that the state
can do on its own. And this has to be coordinated through all
these different partners.
This needs to be sustained. There has to be sustained
commitment and consistent direction from the federal level in
order to ensure that these programs that have been developed
continue.
This is an ongoing threat, and in order for us to be
successful, we have to have integration across all levels of
government and coordination across jurisdictional lines.
We understand the need for partnerships in Texas. We have
very large cities. Four of the 20 largest cities in the nation
are in Texas, and we need to coordinate from the state level
with these cities.
We have sea and airports that are among the busiest in the
country. We need to partner with them as part of this disaster
preparedness.
And over half the U.S.-Mexico border is in our state, and
over a million individuals cross the border legally every day,
and thus we need to work in partnership with our Mexican
colleagues.
We also believe that there is an importance for flexibility
in the overall response, that there is flexibility in preparing
and responding to a pandemic and that different localities have
different challenges that need to be addressed.
We need to have flexibility in the use of human, financial
and medical resources.
Texas is a local-controlled state, and so many of the
decisions for pandemic influenza will be made at the local
level, and they need to have the flexibility to be able to
respond appropriately.
Ninety-five percent of all the funds that come to Texas go
to the local health departments to ensure their ability to
respond.
In summary, as I said, there are three priorities that I
think are critical. One is to have a strong public health
system.
The second is to have consistent partnerships between the
local, state, federal and international partners.
And third, we need to have flexibility, and it is
essential, in order for the state to respond appropriately.
Federal funds allow Texas to build an emergency response
infrastructure to enhance our overall preparedness, and it
needs to be sustained in order for these programs to continue.
And we appreciate the investment from the federal level and
look forward to a sustained partnership. And I appreciate your
time today.
[The statement of Dr. Lakey follows:]
Prepared Statement of Dr. David Lakey
Opening
Good morning Mr. Chairman and members of the Subcommittee. Thank
you for the opportunity to testify on the Texas perspective on planning
for Pandemic Influenza.
My name is Dr. David Lakey and I am the Commissioner for the Texas
Department of State Health Services, known as DSHS, which is the
primary state agency responsible for coordination of pandemic influenza
prevention, detection, response and recovery. I became Commissioner on
January 2, 2007. Prior to that, I served as an associate professor of
medicine, chief of the Division of Clinical Infectious Disease and
medical director of the Center for Pulmonary and Infectious Disease
Control at the University of Texas Health Center in Tyler. At the UT
Center for Biosecurity and Public Health Preparedness, I was the
associate director for infectious disease and biosecurity. In addition,
I chaired a bioterrorism preparedness committee for 34 hospitals in
East Texas and led development of the Public Health Laboratory of East
Texas in 2002.
As the state's public health authority, it is our mission to
promote optimal health for individuals and communities while providing
effective health, mental health and substance abuse services to Texans.
Some of these activities range from ensuring essential public health
services, such as immunizations to children, tuberculosis prevention
and treatment, and food safety regulation to health care safety net
services for our neediest Texans, like low income women with breast and
cervical cancer or treatment for individuals with mental health
illness. Our department also regulates health care facilities and many
health care professions.
Integrating Pandemic Influenza Response into All-Hazards Approach
Today, I am here to discuss the major successes and unique
challenges that Texas has experienced in preparing for Pandemic
Influenza. Texas faces many different emergency situations, ranging
from hurricanes, floods, and tornados to infectious disease outbreaks,
such as measles. That is why Texas has taken an all-hazards approach by
integrating pandemic influenza preparedness and planning into our
health and medical response plans. By taking an all-hazards approach,
DSHS is building an emergency preparedness infrastructure that can
quickly respond to natural, infectious disease and manmade disasters.
In a large state like Texas, with very large and small communities,
this approach requires working closely with local jurisdictions, health
departments and responders. Although influenza pandemics have unique
characteristics, response preparations still need to be part of an all-
hazards plan. After a pandemic outbreak begins, it is too late to
prepare.
First let me outline for you the emergency response structure in
Texas and DSHS' primary responsibilities for health and medical
preparedness and response.
Public Health and Medical Emergency Support
The Governor's Division of Emergency Management directs the state's
role in disaster response: to maintain overall situational awareness
and support community response, to provide guidance to local
jurisdictions, and to coordinate securing and deploying federal and
other resources when state and local assets are insufficient to meet
the need. DSHS serves as the primary agency for public health and
medical services. Our agency is responsible for coordinating health and
medical preparedness and response activities according to the National
Response Plan that addresses not only public health and medical
services, but also nuclear and/or radiological incidents.
Texas Pandemic Influenza Plan Operating Guidelines
Influenza is always on the watch list, and Texas preparations have
been ongoing to get ready for pandemic influenza. In Texas, influenza
surveillance activities continue to expand--from identifying Texas
illnesses to monitoring global events. Texas began developing its
current Pandemic Influenza Plan in 2002. The Texas plan, which
complements the revised World Health Organization plan and the U.S.
plan, includes:
Guidance to local health departments for working with
their community leaders;
Considerations surrounding allocation and distribution
of vaccines and antivirals;
Updated designs for mass vaccination clinics based on
real-time, full-scale exercises;
Development of information toolkits for health care
providers and community leaders.
The plan was developed working in concert with our partners at the
local, state and federal levels, including the private sector.
DSHS Responsibilities During an Influenza Pandemic
In Texas, DSHS is the primary state agency responsible for
coordination of pandemic flu prevention, detection, response, and
recovery, working under the overall framework of the state's emergency
management system led by our Governor's Division of Emergency
Management. These roles include:
Developing and maintaining a statewide pandemic flu
response plan to provide guidance in preventing, preparing for,
identifying and responding to pandemic flu that affects the
state;
Developing and maintaining a statewide pandemic flu
surveillance system to detect circulating flu strains;
Sustaining Texas' ability to rapidly isolate and
subtype flu virus;
Coordinating and supporting training and awareness
campaigns for the public related to identifying, preventing and
controlling spread of pandemic flu;
Ensuring timely dissemination of pandemic flu vaccine
when it becomes available;
Organizing attempts to stop, slow, or otherwise limit
the spread of pandemic flu by providing guidance to local
health departments on activating official response teams,
enhancing disease surveillance, collecting specimens and
starting interventions;
Managing and supporting efforts to ensure timely
dissemination of Strategic National Stockpile (SNS) resources,
including other pharmaceuticals and medical supplies;
Directing provision of disaster mental health to first
responders and those affected.
Recent Successes in Pandemic Preparation
Texas and the Department of State Health Services have achieved
some notable successes in our efforts to conduct preparedness and
response planning for pandemic influenza.
Strategic National Stockpile (SNS) Technical Assistance Review
Just last week, CDC conducted a technical assistance review of our
state plans for the implementation of the Strategic National Stockpile
(SNS) plan. While Texas' score is not official, DSHS has been told that
it will receive a state level score in the high 90's out of a possible
100. This comprehensive review looked at Texas' readiness and ability
to put into action its SNS operations.
CDC Review of Texas Pandemic Influenza Operational Plan
Another recent success was the recognition from the Centers for
Disease Control and Prevention (CDC) which provided a review of the six
priority areas of the Texas pandemic influenza operational plan. These
six priority areas include:
Antiviral Allocation, Distribution and Storage;
Communications;
Surveillance/Laboratory;
Continuity of Operations;
Mass Vaccination, and
Community Containment/Mitigation.
Of these six priority areas, two in particular, Communications and
the Antiviral Allocation, Distribution, and Storage Plans were
identified as best practices in these areas of preparedness. The DSHS
Pandemic Influenza Communication Plan was lauded as being in--depth,
detailed and reflected exemplary effort in its development. While the
DSHS Anti--Viral Distribution Plan was cited for being well--thought
out plans with elements that were exercised and proven to be effective.
Multi-Agency Coordinating Center (MACC)
Another success grew out of the integration of an all-hazards
approach to health and medical emergency preparedness. The back-to-back
impacts of Hurricanes Katrina and Rita tested the capabilities of DSHS,
with federal, state and local partners, to respond to physical and
mental health needs resulting from these natural catastrophes. These
events led Texas to create the Multi-Agency Coordinating Center (MACC),
which provides a state health and medical response across Texas' health
and human services agencies during emergencies including pandemic
influenza. The MACC has allowed DSHS to better coordinate with state
and local partners, in both the public and private sectors, to
strengthen the state's public health infrastructure in responding to
health and medical emergencies. A state-level pandemic exercise was
conducted in mid-August 2007. Lessons learned from that activity and
real-life activations were incorporated into MACC emergency operation
procedures. After action reports relating to the past hurricanes and
recent flooding responses have also led to continued improvement of
systems which enhance pandemic preparedness in Texas.
Increased Surveillance Activities
To enhance disease surveillance activities for pandemic influenza,
DSHS has instituted procedures and policies for the surveillance and
evaluation of cases of Influenza-like Illness (ILI), including a
registered sentinel network of primary care providers. This includes
working closely with the DSHS Public Health Laboratory to identify both
influenza and other respiratory viruses. In addition, DSHS has an
ongoing collaborative relationship with the CDC Division of Global
Migration and Quarantine, both with training exercises as well as true
public health events of concern regarding the potential introduction of
communicable infectious agents, including H5N1 avian influenza and
tuberculosis. These activities are closely coordinated with CDC and
other partners involved with ports of entry and departure, both along
the Texas--Mexico border and other International Ports of Entry at
major airports. These measures include strengthening surveillance,
laboratory, and hospital response capacity and improving statewide
communication about public health and medical threats through the
Public Health Information Network (PHIN). The PHIN is an electronic
system for quick distribution of specific health and medical
information to local health departments, community leaders and medical
providers throughout the state. In addition, the PHIN provides video
conferencing and distance learning capabilities, along with a mechanism
for ensuring the security of health data that is transferred from those
members of the network to DSHS.
Laboratory Response Network
Over the past 5 years, Texas has worked to develop a Laboratory
Response Network (LRN) across the state. Currently, our state has
established 10 high level containment LRN laboratories that can rapidly
diagnose infections of significant public health concern. Of these
labs, eight can now also diagnose H5N1 avian influenza in about three
hours after a sample is submitted to them. This type of infrastructure
facilitates a rapid public health response throughout the state and is
a critical component in the early identification of a pandemic
influenza outbreak.
Some Remaining Challenges in Pandemic Preparation
Size of Texas and its International Border with Mexico
One of the biggest challenges in preparing for pandemic influenza
in Texas is reaching all our residents quickly. The size and diversity
of Texas results in a wide variety of needs and requires a large number
of resources to meet those needs. It is further from El Paso to Houston
than it is from El Paso to San Diego, California. Texas has four of the
nation's largest cities by population and also some of the most rural
and sparsely populated areas in the country. In addition, over half of
the U.S.--Mexico International Border is in a part of Texas that covers
32 different counties and four separate Mexican states. Communications
between all these different public health agencies is essential. When
you consider that over a million legal crossings take place each day
along this border, it is a test of theTexas public health system to
work in a binational effort with Mexico to identify and prevent the
potential for pandemic influenza. Other factors that complicate the
disease surveillance activities along the Texas--Mexico border is that
cross-border trade more than tripled since 1993, along with rapid
population growth on both sides of the border. Added to the challenges
represented by the Texas--Mexico border are other points of entry such
as sea ports and international airports. Strong public health systems
along the Texas--Mexico border and at other designated U.S. points of
entry serve not only our state but the entire nation to minimize any
potential for spreading pandemic influenza in the United States.
Texas: A Local Control State
Texas is a local control state, and many final decisions about
pandemic influenza will be made at the local government level. The DSHS
plan was developed with local input to provide a simple, flexible
process adaptable for state, regional, and local jurisdictional use. In
those areas of the state where there is no local health department, the
DSHS regional offices serve as the local health authorities. The goal
has been to ensure that Texas continues to build and enhance processes
to provide public health planning and response capacity at all levels
in all communities. To build local preparedness capacity, DSHS began
contracting with local health departments (LHDs) in 2002. DSHS has
directed 95% of federal funds to preparedness activities at the local
level including direct contracts with local health departments.
Separate funding is provided to local governments through two CDC
sponsored special initiatives, Cities Readiness Initiative (CRI) and
Early Warning Infectious Disease Surveillance (EWIDS).
To be successful locally, it is essential to allow more flexibility
for differences in responding to local needs. Maintaining essential
public services is a big concern. Hospitals could be inundated; medical
staff could be in short supply; police forces may face citizen
discontent and other security issues; and keeping citizens supplied
with food, clean water, and other basic essentials could become a
serious challenge, especially if workers themselves are sick or home
caring for loved ones.
Restrictions on Use of Federally-subsidized Antiviral Medications
Antiviral medications can be effective in preventing and treating
influenza viruses in a pandemic, especially in reducing the duration of
symptoms and some influenza complications. Their use forms one part of
a comprehensive approach taken by DSHS to containing pandemic
influenza. This approach begins with a strong seasonal flu program to
increase vaccination rates, improve surveillance, provide education,
and develop best practices for treatment. Planning for antiviral use
includes identifying target groups to receive these drugs, allocating
and delivering antiviral drugs, communicating critical information, and
monitoring the effects of antiviral drugs. The priority groups to get
any available influenza vaccine or limited antivirals during an
influenza pandemic may be different from the groups identified for
influenza shots during a typical influenza season.
Texas had the opportunity to purchase the antiviral medications
Tamiflu' and Relenza' at a deep discount, based
on a low federal contract price. The Texas Legislature appropriated $10
million in general revenue funds in 2007 to purchase additional
antivirals for the state supply under the federal contract. This will
purchase about 675,000 courses. About 1.5 million courses remain
available to Texas for purchase at the federally subsidized price. This
remaining amount has been offered to eligible local entities to
purchase at the federally subsidized price.
However, there are important drawbacks to purchasing antivirals for
stockpiling under this special federal contracting price. There are
national policies that prohibit using medications bought on the federal
contract for anything but a pandemic declared by the CDC and thus we
are not allowed to rotate through the stockpile. Furthermore, since
these antiviral medications have a limited shelf life of about five
years, our inability to use antivirals purchased under the federal
contract for seasonal flu or other illnesses when the fifth year draws
close impacts our state's investment in these medications. Other
factors include the uncertainty as to whether currently available
antivirals will be effective against an emerging, unknown pandemic flu
virus. Better and/or less expensive antiviral medications may become
available between now and the start of a pandemic. These unknowns and
limitations create a challenge in making the case that the purchase of
antiviral medications is a good investment.
A Pandemic is Unique
There are differences in health and medical responses required for
a hurricane versus a pandemic influenza outbreak. A pandemic is unique
in that this is a societal issue, and not just a medical issue. The
state and local communities will have to adjust by modifying their
normal medical and non-medical responses, such as employing social
distancing measures like school and public closures and sheltering in
place to counter spread of pandemic influenza. A number of other
factors exist making a pandemic influenza response unique. That is why
we believe that a multi-faceted, comprehensive approach will better
prepare Texas for containing pandemic influenza.
One challenge is preparing for many different response scenarios,
including the inavailability of vaccines and antivirals. People will
likely need to change their behaviors to reduce illness and death. In
the absence of an effective vaccine, ``social distancing'' will be a
key tool in slowing the transmission of a pandemic influenza. ``Social
distancing'' is a term which encompasses such things as school
closures, cancellation of public events, working from home, minimizing
travel on public transportation, and a range of other steps to
essentially keep people away from each other to mitigate spread of the
disease. The detailed decisions on such restrictive measures must be
made locally. The need for social distancing will take on a greater
importance as schools may need to close and activities such as shopping
or large-group activities may have to be limited. Local communities
might have to figure out how to maintain these restrictive measures for
an extended period.
Texas is one of 18 states taking part in Social Distancing Public
Health Law Project sponsored by the Association of State and
Territorial Health Officials (ASTHO) in collaboration with the Centers
for Disease Control and Prevention Public Health Policy Center (CDC).
The project's goal is to assist states in assessing their legal
preparedness to implement social distancing measures for both declared
and undeclared public health emergencies. A careful review social
distancing laws as they currently exist in Texas has already been done.
We are working with state elected officials, other state agencies,
along with private and other public partners to identify gaps,
omissions, and potential conflicts between laws and if statutory
changes are needed.
Worker safety is another issue that must be addressed. In
responding to a pandemic influenza outbreak, the very workers that are
responsible for helping to control the outbreak and care for the ill
become at risk of being infected. More than that, workers who keep
essential services such as food and water in supply are susceptible.
For that reason, the federal government and states have purchased
antivirals as one tool to help protect first responders, health care
personnel and those essential infrastructure workers. Education of
infection control practitioners is also critical to assessing potential
exposure situations and preventing the spread of the disease in the
healthcare setting to other employees and patients. Other worker safety
supplies, such as masks, are important for response efforts, but are
not something that we would normally stockpile for a typical disaster
response.
In pandemic preparations, we must plan for a scenario where 30 to
40 % of the workforce is absent. A key effort will be continuity of
operations planning. Planning for scenarios where such a large number
of the workforce is not present represents a challenge for government
and also for the private sector. DSHS has been involved in this effort
on many fronts, including putting together a business summit and by
working with other state agencies to coordinate the human resources
policies of Texas state agencies in the event of a pandemic. More work
is needed in this area to help educate our businesses and communities
of the potential impact of a pandemic and strategies that will help
mitigate its impact.
A final factor relating to the uniqueness of pandemic influenza
response is the difficulty hospitals will have due to their limited
surge capacity, especially in the area of intensive care. Because the
pandemic occurs in waves and affects such a broad cross-section of our
population, we can anticipate that even a mild pandemic would be a
major stress on the medical/hospital system. Hospitals are a critical
component of the response system in a pandemic flu outbreak and direct
discussions with hospital organizations and their members is necessary
to determine how this type of surge will impact the operations of
hospitals.
Closing
Despite the complexity and challenges that come with pandemic
influenza preparedness planning, DSHS is always working to enhance the
public health infrastructure across the state. That includes continued
efforts to coordinate assessment and planning with not only our local
partners, both public and private, but other neighboring states and
Mexican Border States for prevention and containment of illnesses. The
goal has been to ensure that Texas continues to build and enhance
processes to provide public health response capacity at all levels in
all communities. CDC Public Health Preparedness (PHP) funding over the
last five years has allowed Texas to build an emergency response
infrastructure in those areas where it did not previously exist and to
enhance PHP programs in the larger metropolitan areas. As Texas' Public
Health Preparedness and Response efforts have evolved, particularly
with the threat of pandemic influenza, focus has shifted from building
infrastructure to building response capacity in support of a program
that has grown in sophistication and complexity. It is my hope that the
federal government will give states the flexibility to be able to make
the necessary adjustments to meet the diverse needs of its population
and the continued support to build and maintain the capacity to protect
our state and nation from an influenza pandemic.
Thank you for this opportunity to address you on a subject of great
public health importance.
Mr. Langevin. Very good. Thank you, Dr. Lakey.
With that, as I said, it is my intention to recess for
about 15 minutes or 20 minutes. We have two votes. We will come
back for a very brief round of questions.
Dr. Lakey. Thank you.
Mr. Langevin. Thank you very much.
The committee stands in recess.
[Recess.]
Mr. Langevin. We appreciate the panel sticking around for a
few more minutes, and we will get right to the questions. I
will begin with Dr. Cirillo.
In your opinion, are hospitals and major medical centers
getting enough federal funding and guidance to prepare for an
influenza pandemic?
And how do you propose getting all of the funding resources
and guidance that you feel are necessary down to primary care
providers?
Dr. Cirillo. I will be honest with you, Congressman, that
there has not been enough money, and the amount of money that
it would take to say that we are fully prepared, if we could
ever say that, is very significant.
We did calculations in Rhode Island for a year-long
pandemic in order to try and have enough medical equipment,
supplies and to be able to provide some reimbursement to health
care providers who would come and assist the state, and the
price tag for that, for 1 year, was $550 million.
And those were, you know, rough calculations, but that
gives you some sense of the amount of money that it would take
to really continue to deliver health care to, you know, an
increasingly sick and large number of patients.
I think what we have done is tried to build on those
partnerships that we have had through the Hospital Preparedness
Program. That has allowed us to try and create common
infrastructure, to create common efficiencies with the
hospitals.
The challenges that we face, though, are that even if we
can stand up alternate care sites and find extra space, the
issue of where will the ongoing supplies come from once we get
through our initial cash, and where will we continue to find
and recruit health care providers--we have discussed the issues
of doing, if you will, battlefield promotions.
You know, how can we take medical students even early on in
their career and quickly give them some just-in-time training
to increase their ability to provide care?
How do we take family members and teach them the basic
skills of family health care, to try and allow people to be
taken care of at home or at an alternate care site or at a
hospital?
So those challenges of resources are still the critical
ones that although we can create that infrastructure, when the
rubber really hits the road, I think my greatest concern is
that the resources that we have will be utilized fairly
quickly.
And then it will become increasingly difficult to keep the
same standard of care and the challenge of decreasing standards
of care or altering them really is something that is very
difficult.
Mr. Langevin. Let me ask this question, because it is
funding related, and the panel can comment on either the
previous question or the current one that I have.
I understand that many of the preparedness grants from HHS,
for example, are 1-year grants. Why is this?
And wouldn't it be more efficient to put more multiyear
grants out there, which would encourage states and agencies to
develop longer-term, more broad-reaching goals?
We will start with Dr. Cirillo, and then if anyone else
would like to comment.
Dr. Cirillo. I think we have tried to encourage our federal
colleagues to look at that as an option. I would like to share
a very Rhode Island sailing analogy, which is if I decide I
want to sail from Newport to the cape, I know where I want to
end up.
Along the way, I may have to change and tack with the wind
a little bit, but I have a goal of where I want to be in a
certain period of time.
And on our level, if we continue to change priorities and
change terminology and change strategies every year, it really
takes more away from actually being prepared and devotes more
time, money and resources to just managing the program, and
that is really not what we want to do.
So I think a longer strategy--much as the bills and the
programs are authorized for a multiyear basis, we would like to
see at the state level that the grants are administered on a
multiyear basis so that we can establish long-term goals, long-
term strategies and keep moving toward those in a coordinated
fashion.
Mr. Langevin. Any comment from the panel?
Mr. Shult. If I could maybe bridge the two questions, I
agree with all of the previous comments. We have gotten
substantial, although now declining, levels of funding to build
laboratory capacity in terms of our diagnostic testing, our
laboratory networks and developing an emergency response
culture.
That needs to be sustained. A lot of that money now is
going to sustaining some very highly trained staff where if the
money goes away, we are going to be in jeopardy hanging onto
them.
So I think Wisconsin has benefitted probably better than
some other states in that regard.
I would echo the comment that--well, and then to make up
the shortfall, funding essentially comes out of my operating
budget in my division and ultimately my public health lab.
It makes it difficult, if we are making decisions on a
year-to-year basis, never quite sure how much funding is going
to be there, and how much shortfall I am going to have to make
up.
So we have enough, we have had an adequate amount to build
substantial capacity capability. That needs to be sustained,
but it would help us a lot to be able to do this on a multiyear
basis so we can set up the long-term goals and maybe shift
priorities.
Mr. Langevin. Anyone else?
Dr. Caldwell. I can tell you that the national county and
city health officials are very concerned that we have seen
declines of 20 percent or more in the all-hazards preparedness
dollars that have gone out to local departments of health--and
to know that the pandemic influenza preparedness funding is
expected to terminate in August 2008.
You know from your own experience that when federal
resources are made available that states and communities will
take those resources and match them.
They will do that more readily if they know there is a
sustainable commitment over time. And a lot of this has to do
with hiring personnel, as you are well aware.
And that is the core part of what we have been trying to do
initially, is to build our capacity of professionals to help us
with the planning as well as the development of partnership-
building and ultimately of exercising and evaluating this.
This is a long-term commitment. The long-term vision is
there. And the federal government needs to provide the strength
and the foundation to say we are making this a priority in many
ways through the passage of certain acts that this is the goal
that we have, the public health preparedness and emergencies
act, what it is we need to do, and also the resources behind
it.
When my county executive sees that there is going to be
possibly a termination of funding, he is very uncertain of
whether he is also going to be able to match money as well, or
start a program and then know that maybe he will have to be
fully responsible for it completely, and then not even know
whether that may be something that could be implemented.
So therefore, not only in my jurisdiction, but across the
country people are wondering, ``Well, should we go and make the
extra effort or are we going to be stuck?''
Mr. Langevin. Dr. Lakey, any comment?
Dr. Lakey. I think my comments echo the comments that have
already been made. Every year significant effort comes from our
agency in the whole grants management process of reallocating
the funds.
And having sustainable funding to the local health
departments would go a long way in getting them to step up and
be a full partner in this. Actually, on the local side, there
is a lot of effort that they have to put into every year in
this whole grants management project.
I think also, on your first question, I don't think the
hospital component is a huge issue. For example, in Austin, a
city of 1.3 million, we would expect that we would have 13,000
individuals that would be hospitalized during a pandemic.
And so there are significant preparedness activities that
have to take place in the hospitals, and they need the
consistent funding.
And they also need to make sure that when that occurs there
is some flexibility on how they are going to be able to bill
patients and be able to get the ongoing revenue.
If they are taking care of patients in a non-traditional
manner on different floors, et cetera, are they still going to
be able to keep the billing--be able to keep the financial
security of the hospital--during that time period? And that is
an issue that I hear from hospitals when I discuss it with
them.
Mr. Langevin. Thank you.
The chair now recognizes the ranking member, the gentleman
from Texas, for 5 minutes.
Mr. McCaul. Thank you, Mr. Chairman.
Well, first I want to thank the witnesses for their
patience. I know it has been a long hearing, and we don't
control the votes--at least, I have no control over that. And
thank you for being here.
You know, the long-term commitment is important on the part
of the federal government on an issue that is so important as
this one.
I think long term we will have the technology, hopefully,
as we heard on the prior panel, to develop the technology for
vaccines that could be readily made within a matter of weeks.
But until that time, we have to look at antiviral
medications and a whole host of other things to deal with this
situation if it happens before that time. We are long overdue
for a pandemic outbreak in this country. It has been about 40
years.
First, I wanted to get a comment from the panel on--and I
asked this question of the DHS officials, but I would like to
get your perspective from a state and local level.
How prepared are we and ready are we in terms of the
antiviral stockpile in this nation in the event a pandemic
broke out today? And why don't we just go down the panel,
starting with you, Dr. Cirillo?
Dr. Cirillo. I was encouraged to hear, Sir, that at the
federal level clearly the production capacity has exceeded what
was expected. And that is encouraging to hear.
The federal government had established some federal
stockpiles and it sounds like they are meeting those goals,
according to Admiral Vanderwagen.
I think the challenge for us is that there is still an
expectation that the states were going to participate through a
negotiated contract in purchasing antivirals to keep at the
state level.
And while from a policy and strategic point of view we
agree with that, the challenge is that that is an investment
that really is at risk.
And again, I would reference that those medications that we
choose to stockpile at the state level are not currently
available to be included in the shelf-life extension program.
So if I purchase N95 masks or hand gels, those are items
that are really able to used for lots of different events, and
they don't go away. They don't expire.
The decision to invest, you know, scarce resources
financially into antivirals--and if we don't have the next
pandemic for another 4 years and those expire, I really have
lost that investment.
And so that really is a challenge for us. So the decision
at the state level of how much financially to invest in
antivirals really is the basis of--that is an at-risk
investment.
Am I better buying more masks or, you know, investing in
something that I know will expire and I may not get any value
out of it?
Mr. McCaul. Dr. Shult?
Mr. Shult. Just to reiterate some of the comments, I can't
speak directly to the antiviral stockpiles, but to point out
again or reemphasize the critical need for accurate, very
rapid, highly reliable diagnostic testing to make best use of
the stockpiles, however they are.
And another element of that is another key role right now
for public health laboratories working with the CDC is monitor
the emergence of antiviral resistance that we have already seen
with one whole class of antivirals.
And this is something that would have to be monitored
throughout the pandemic period, which could last 18 months to 2
years.
So however the stockpile sorts out, the laboratories are
going to need to have that very rapid diagnostic testing and
surveillance that goes along with it.
Mr. McCaul. That is a good point.
Dr. Caldwell?
Dr. Caldwell. Yes, it is concerning to me at some level
that there is so much emphasis being put on antivirals, which
we don't even know are going to work, investing millions upon
millions of dollars on that, while at the same time not making
a one-to-one commitment for the resources we need to actually
get the vaccine or antivirals into people's hands.
And that is where local health departments come in. You
know, we are the ones responsible on the ground for accepting
the strategic national stockpile. And we have had experience in
having moments where we have practiced trying to get medicine
to people very quickly.
Let's go back to the 2004 seasonal flu vaccine shortage,
where there were delayed shipments and people were anxious and
concerned, and the public became extremely vulnerable and
worried.
We somehow in Dutchess County were able to give out nearly
6,000 doses in a couple days to our most vulnerable
populations. But that is only actually because of the efforts
that we had made in emergency preparedness and practicing. We
did better with that.
And we need there to be a recognition that the unknown
strain, the unknown--hopefully we will be able to develop a
vaccine quickly. But the amount of money that you have in
antivirals that if they work, maybe--you know, are they going
to take 1 day off of the illness, or are they actually going to
save lives? We just don't know.
And I think that if you are going to make the commitment
into putting dollars into medicines, you need to at least make
a one-to-one commitment into putting it into the strategies,
the implementation strategies, the practice and the planning at
the local level.
Mr. McCaul. That is a very good point.
Dr. Lakey?
Dr. Lakey. Thank you. I agree that antivirals are only one
component of a comprehensive plan for the state. I think it is
an important part of the comprehensive plan and for the state.
I worked this issue quite a bit this last legislative
session in Texas. We were offered the ability to buy $34
million worth of antiviral medicines. It came out of the
legislative session with $10 million, and that was a hard sell.
One of the reasons that it was a hard sell was with ongoing
health concerns in the state, spending $10 million for a
medicine that has a 5-year shelf life and the unpredictability
of pandemic influenza made a lot of other issues seem more
important at the state level than purchasing the antiviral
medicines.
I think that the 5-year shelf life played a key role in the
difficulty we had in making the case for the state to invest in
the antiviral medicines. And so I think that is a key issue
that needs to be looked into.
Mr. McCaul. And, Dr. Lakey, following up on that, can you
describe the national policies that prohibit using these
medications bought under a federal contract?
Dr. Lakey. Under the federal contract, it is negotiated at
a low rate and with a national subsidy, and with that, we are
not allowed to utilize the medicines except for a pandemic, in
a pandemic influenza.
We are not allowed to rotate through the stockpile so that
we could use so much this influenza season and replace it with
additional antivirals that are purchased. Basically it is just
put on a shelf and we are not allowed to utilize it except for
the pandemic.
And that is where this 5-year shelf life really comes into
play.
Mr. McCaul. That may make some sense to take another look
at the contracts so we can fully utilize our resources.
One thing we discussed, Dr. Lakey, yesterday--I wanted you
to expand on--is in terms of hospital bed space, the
availability, you mentioned a concern of yours in terms of your
ability to inspect the hospitals as it relates to CMS's ability
to fund.
Can you elaborate on this? And what, if anything, would you
recommend we do at the federal level to fix this?
Dr. Lakey. Sure. The situation is that our agency does
initial hospital licensing, initial inspections to hospitals,
to allow them to bill Medicaid and Medicare.
We have been told that initial inspections for new
hospitals are the last priority, that we are not allowed to do
them unless all other types of inspections are done, and
basically that is a situation that never occurs.
And so we have multiple hospitals in Texas that are
awaiting inspections in order to come up and be able to bill
Medicaid and Medicare as part of their business plan that are
not allowed to do that at this time.
And so we have 17 hospitals currently sitting in Texas
awaiting--and they are ambulatory care centers and smaller
hospitals that we can't inspect.
There are other options for the hospitals. They can go
through JCAHO accreditation. They can be deemed under a parent
hospital so they are part of a feeder system into that
hospital.
Or if there is an access-to-care issue--the problem for
Texas is we are not an access-to-care state, and so we have
offered to use general revenue and other sources in the state
to either take care of that backlog or to do the initial
inspections.
We have offered to be able to couple them with other type
of inspections and then told that we can't do that. And so
there are multiple facilities in Texas that we can't bring up
because of those issues.
Mr. McCaul. I am curious with the other three panelists
whether you are experiencing that same problem in your
respective states.
Dr. Cirillo. I don't think we share the same challenge that
Dr. Lakey is facing in Texas. I think our greatest challenge in
terms of hospitals is the issue of capacity.
And again, within Rhode Island, the hospitals operate on an
inpatient basis at greater than 95 percent capacity on every
day.
And so when we talk about where would we accommodate surge,
again, not just for pandemic--we had the experience in Rhode
Island of the Station Nightclub Fire, and that was a challenge
to try and despite heroic efforts by first responders and
people at hospitals, to create that capacity in a real-time
event.
And that really is the challenge, to deal with the
unexpected. So my concern on the hospital level is how do we
continue to support them in difficult financial times, to
invest in preparedness when they are really trying to invest in
their day-to-day operation, to remain open.
Mr. McCaul. Any comments from the other two?
Mr. Shult. And again, from a laboratory perspective, we
have spent a lot of time working with the clinical labs
throughout the state and bringing them up to speed in terms of
emergency response, their role in a pandemic and what the
pandemic is going to do to them.
We are all going to be affected by this. And they have real
concerns as well, similar to what have been echoed here as far
as their capacity to respond, keeping in mind they are critical
to maintaining day-to-day patient care that has to go on
anyhow, much less the complications that are going to arise
from a pandemic.
So right now we have been working with them, but they are
feeling very much at a loss as to whether they are going to be
able to respond adequately to serve the clinical or their
clinicians' needs.
Mr. McCaul. Dr. Caldwell?
Dr. Caldwell. Yes, in the state of New York, we are
actually cutting back on hospitals and beds, believe it or not,
because they feel there is an oversupply, so it is in some ways
a reverse problem.
But when you look at, you know, how are we trying to
prepare for the large part of our population being sick and
very ill, we are thinking that we are going to have to have a
lot of people taken care of at home.
And right now, part of our strategy and planning in
Dutchess County and many of my colleague counties is to work
with our home care agencies and to work with them and build
their capacities to develop some unified emergency preparedness
home care plans, enabling our residents to know that there will
be people available to deliver some medical and nursing care in
their homes if they get sick.
Now, are we going to be able to activate hundreds of
ventilators, and where are you going to get the staff to
activate these ventilators? And I just don't see it being a
realistic possibility. I think there is going to be some type
of very rationing situation. It is going to be hard.
I mean, we are not going to be taking over hotels. People
used to say, ``Oh, we are going to take over hotels and put
people there.'' That is not going to happen. The hotels aren't
going to want it. Nobody is going to want to go to the hotel,
and nobody is going to staff the hotels.
And so we need to look at what already exists in our
community, try to think of how people are going to approach the
situation, given that it is not just going to be people getting
sick. All kinds of things are going to be going on.
There is going to be distribution of food problems. People
are going to have trouble getting their food and their water
supplies and their other regular medicine.
So I do have one other comment about the previous topic of
pharmaceutical stockpile and pharmacies.
Instead of us in Dutchess County sort of going out and
buying our own mini-stockpile, what we have done through our
relationship-building efforts is work with our local
pharmacies, so we have a memorandum of understanding with all
the pharmacies in our county to know what is on their shelves.
And should there be an outbreak, they will then immediately
inform us of what is on their shelves, so that will be our sort
of--rotating many stockpiles, which won't cost us any money.
And of course, they may not have all that we want, but it
is at least something that we can have some control over at any
time, and it doesn't cost us any money.
As a matter of fact, it is an investment in our continued
relationship. While it is not antivirals, it may be something
else, like, for example, some other antibacterial that we may
need for some other agent that may come along.
Mr. McCaul. That is very creative.
And I appreciate the chair's indulgence. And just in
conclusion, I do want to stress again the importance of
exercises. I think those are very important. I hope that your
partner at the federal level will work with you on those.
And lastly, Dr. Lakey, you mentioned the border, and I
think that is an obvious concern on a lot of levels, but
certainly from a health standpoint, in terms of who is coming
into the country. I think we need to have a better level of
control over who is coming into the country.
And certainly, when we had the avian flu outbreak, knowing
who is coming over from those parts of the world that could be
impacted--and I know that on the science and technology
standpoint, there has been some pretty good technology that is
out there that could potentially spot if someone who has a high
fever, for instance, coming through an airport.
And so I hope that we will be able to make some progress on
that level as well.
And with that, I yield back.
Mr. Langevin. I thank the gentleman.
I want to thank the panel for being here today as well as
the previous panel. I thank the witnesses for their valuable
testimony and the members for their questions.
We obviously have a lot of work to do in this area. We look
forward to a continued partnership at the local, state and the
federal level to make sure that we get this right and we can
protect the American people from both pandemic flu or another
public health threat.
Thank you very much again.
The members of the subcommittee may have additional
questions for the witnesses, and we ask that you respond
expeditiously in writing to those questions.
Hearing no further business, the subcommittee now stands
adjourned.
[Whereupon, at 1:17 p.m., the subcommittee was adjourned.]
Appendix I: Letter
----------
House of Representatives,
Subcommittee on Emerging Threats, Cybersecurity, and
Science and Technology,
Washington, DC, October 25, 2007.
Hon. Jim Langevin
Chairman, Subcommittee on Emerging Threats, Cybersecurity, and
Science and Technology, 109 Cannon House Office
Buildig, Washington, D.C. 20515
Dear Chairman Langevin: Thank you for allowing me to tesify
about pandemic influenza preparedness before the Subcommittee
at its hearing on September 26. It was an important opportunity
to enhance communication between the federal government and
states as we work together to strengthen health and security
across the nation.
Please allow me to make two brief clarifications regarding
my testimony. I mentioned the percentage of preparedness
funding that Texas has directed to the local level including
direct contracts with local health departments. That statement
should have referred specifically to pandemic influenza
preparedness funding. In addition, the percentage of funding
awarded for local and regional pandemic preparedness activities
was overstated. The correct figure is ninety percent.
Again, I appreciate the opportunity to present to the
Subcommittee regarding these issues. Please contact me if I can
ever be of assistance.
Sincerely,
David L. Lakey, M.D.,
Commissioner
Appendix II: Additional Questions and Responses
----------
Questions from the Honorable James Langevin, Chairman, Subcommittee on
Emerging Threats, Cybersecurity, and Science
Responses from Michael C. Caldwell, MD, MPH
Question 1.: What additional resources are needed at the local
level to prepare for and respond to pandemic influenza? What is needed
at that level--that is not needed at other levels of government or in
the private sector?
Effective pandemic influenza preparedness at the local level
requires a continued, iterative process of planning, testing the plans
either through response to a real event of lesser magnitude or via
``tabletop'' exercise, identifying gaps and areas needing improvement,
achieving those improvements, and re-testing. While this methodology is
not unique to the local level, locally it requires reaching out to
every community organization, institution, or agency that will be
affected by a pandemic to engage them in practical response planning.
The breadth and depth of activity required to build and sustain such
community engagement, unique to the local level, is a long and labor-
intensive effort. It can be accomplished only with a sustained
commitment of sufficient funds to pay for the people that do this work.
Local pandemic influenza preparedness is not simply a matter of one-
time capital purchases of medications, vaccines, or equipment--rather,
it requires constructing and sustaining the community response systems
that will make a difference in survival rates. NACCHO believes that a
return to previously-appropriated levels of funding for state and local
public health preparedness ($940 million in FY05), accompanied by
performance and accountability measures that genuinely reflect the
local planning, exercising and continuous improvement that is needed,
would enable consistent progress. Moreover, it is important to address
the funding levels for anti-viral purchases and the shelf-life
extension problem that now discourages state or local investment.
Question 2.: The best preparation for public health emergencies
involves skilled public health workers who plan and exercise their
plans for emergency response jointly with local elected officials,
police and fire departments, emergency managers, hospitals, physicians,
schools, businesses, and other community partners. Please describe how
this has occurred in Dutchess County regarding pandemic influenza
preparedness.
In Dutchess County, we have prepared and distributed informational
materials and have offered trainings to area businesses, schools, faith
based organizations and other entities as part of our Pandemic Flu
Emergency Preparedness activities. We have organized table top
exercises with our area partners, including the local hospitals.
Additionally, our regular flu immunization clinics have been used as
opportunities to drill the techniques that will be needed in an
emergency situation, when medications would have to be distributed to
the public in a short period of time. Nine clinics were held in
November and December 2006 throughout the county. Each site selected
could accommodate large numbers of attendees without traffic problems
or long waiting times. Clinic hours were increased over the years and
each site had inside waiting areas. Other agencies such as the
Sheriff's Department, the Department of Mental Hygiene, Public Works,
and the Office for the Aging assisted in mounting these efforts. This
type of exercise is being replicated again this year as we run our 2007
flu clinics.
Furthermore, Dutchess County has recruited a local Medical Reserve
Corps of over 300 volunteers whoa re been trained to provide assistance
with medical care, special needs care, as well as non technical needs.
This cadre of citizen volunteers is meant to be fully integrated into
the County's emergency planning and response program.
Preparing for a pandemic is part of more comprehensive Emergency
Preparedness efforts, looking at multiple scenarios. In Dutchess
County, we have also been working on a continuity of operations plan.
During a pandemic event, more than 40% of the workforce could
potentially be unable to come to work. This plan addresses issues of
providing a safe environment, prophylaxis, training and tools needed to
perform essential public health functions in our community. Such a plan
is critical in a pandemic when the public health and other public
resources will be stretched thin providing vaccines and antivirals to
the public in a mass clinic or Point of Distribution site.
Question 3.: What can the federal government do to assist city and
county public health personnel strengthen and coordinate surveillance
at those levels? How do you see information from localities throughout
the country, rolling up into a cohesive real-time disease surveillance
picture?
Response: Local health department (LHD) involvement in
biosurveillance systems development and implementation is critical.
LHDs are the traditional entry point for routine disease surveillance
and investigation, and function as first responders in a public health
emergency. As such, LHDs are keenly aware of the information needed to
monitor for public health emergencies and mount response and mitigation
activities. LHDs must be actively involved in the definition of data
and functional requirements for biosurveillance systems and in the
local implementation of such systems. State and federal public health
agencies must ensure that LHDs have timely access to any data collected
about their local community.
Existing relationships between LHDs and local hospitals and
providers should be leveraged for biosurveillance implementation
efforts. LHDs have established relationships with hospitals, physicians
and other healthcare providers in their communities for disease
reporting and preparedness planning and response. As most responses to
emergencies are locally managed, it is critical that these existing
relationships are maintained and strengthened to ensure rapid response
to public health threats. These relationships remain essential even
when a state health agency or the CDC initiates the data collection
effort, such as with the CDC's implementation of BioSense.i
Additionally, over-reliance on biosurveillance data as the only
indicator of a public health emergency must be avoided. Electronic
biosurveillance systems will not replace astute clinicians and LHD
relationships with their clinical communities to detect, monitor and
control public health emergencies. Uniform national adoption of an
electronic medical record is absolutely essential to eventual
development of any fully effective real-time disease surveillance
system.
---------------------------------------------------------------------------
iBioSense is the national program designed to improve
the nation's capabilities for real-time biosurveillance and situational
awareness at a time when the vast number of health-related information
systems that exist nationally vary in their ability to share data to
support immediate biosurveillance needs.
Question 4.: In your testimony, you state ``. . .we have seen mixed
messages from our federal leadership. There does not seem to be
adequate coordination or cooperation between the planners of Health and
Human Services and the Department of Homeland Security.'' Please
provide examples of mixed messages from federal leadership, as well as
examples of inadequate coordination and cooperation between HHS and
DHS.
HHS and DHS have separate and uncoordinated grant programs for
state and local preparedness. Pandemic influenza planning is a major
expectation of the CDC grants, but not of the DHS grants for police/
fire/emergency management. DHS has undertaken the BioWatch surveillance
initiative, but it has not been coordinated with any HHS
biosurveillance initiatives, although the responders at the local level
are the same.
Question 5.: In your testimony, you state ``. . .we have seen clear
examples of us being left out of the development of the National
Response Plan.'' Please provide us with some of these clear examples.
Response: There was no representation of local health departments
on any of the 12 workgroups that were formed to fashion the detailed
revisions of the National Response Plan.
Question 6.: In your testimony, you state ``. . .in the state of
New York, we are actually cutting back on hospitals and beds, believe
it or not, because they feel there is an oversupply. . .'' Who believes
there is an oversupply, and on what data are they basing this belief?
Please provide data regarding the numbers of hospitals and beds, as
well as to what numbers of each the stat is cutting back. What specific
impact do you believe this will have if we are to have an influenza
pandemic?
Response: In New York State, the hospital environment has been
dominated by mergers and restructuring, which inevitably have an impact
not only on the number of beds, but also the types of beds available.
This will in turn affect the ability of hospitals to accommodate a
surge that would be associated with a pandemic.
Response: New York State has recently undergone an extensive review
of its hospital system structure and capacity. The formal review was
known as the ``Berger Commission'' and its detailed report can be
accessed at http://www.nyhealthcarecommission.org/ While some parts of
New York State operate at a high hospital bed occupancy rate, many
areas of the state do not. The Berger Commission was created to address
the concern that overall, New York State is over-bedded by
approximately 25 %. The Commission noted that ``a fundamental driver of
the crisis in our health care delivery system is excess capacity. New
York is over-bedded an many hospital beds lie empty on any given day.
The statewide hospital occupancy rate has fallen from 82.8% of
certified beds in 1983 to 65.3% in 2004, a decrease of 17.5%. Occupancy
rates vary by region and are especially low in Wetern, Northern, and
Central regions.''
Question 7.: According to the Implementation Plan for the National
Strategy for Pandemic Influenza, ``The Federal Government shall, and
State, local, and tribal governments should, define and test actions
and priorities required to prepare for and respond to a pandemic,
within 6 months'' of when the Plan was released--so the deadline would
have been October 2006. What are the challenges here? Are you waiting
for the Federal government to provide you with guidance and resources?
Response: The initial CDC grant guidance for the first phase ($100
million) of pandemic influenza funding was released in May 2006.
Planning and exercising the full panoply of local resources required
for response is a continuous iterative process, as described above, and
it certainly takes more than four months. As funding dedicated for
state and local pandemic influenza preparedness ends, it will be
essential that federal expectations for pan flu preparedness and for
all-hazards preparedness be harmonized and realistic within the
resources made available.
Question 8.: According to the Implementation Plan for the National
Strategy for Pandemic Influenza, ``State, local, and tribal law
enforcement agencies should coordinate with appropriate medical
facilities and countermeasure distribution centers in their
jurisdictions to coordinate security matters, within 6 months'' of when
the Plan was released--so the deadline would have been October 2006. To
your knowledge, has any of this coordination taken place? If so, how,
and if not, how would you recommend this happen?
Planning and exercising of Points of Distribution for the Strategic
National Stockpile has taken place in many jurisdictions with law
enforcement involvement for several years now, and most intensively in
those that receive Cities Readiness Initiative funding. DHS
expectations for law enforcement engagement with medical facilities and
countermeasure distribution centers should be directly and explicitly
connected to and consistent with HHS expectations for hospitals and
health departments.
Question 9.: What roles do associations play in assisting their
constituents with emergency and pandemic preparedness?
Response: NACCHO has developed a robust collection of on-line tools
and a peer assistance network for local health departments engaged in
emergency preparedness. NACCHO also coordinates and disseminates the
work of eight local Advanced Practice Centers for Public Health
Preparedness, which develop and evaluate cutting-edge preparedness
tools and methodologies. We share information on federal actions and
provide input to a vast array of HHS and CDC workgroups and advisory
groups.
Question 10.: The Government Accountability Office (GAO) says in
its report that State, Territorial, Tribal, Local, and other
stakeholders need to be involved in providing input to the National
Strategy for Pandemic Influenza and its Implementation Plan, especially
as the National Strategy evolves. If you were at the White House, how
would you ensure this happens?
Response: Local stakeholder representatives should be identified
and engaged at the beginning of the federal planning process They
should be engaged in review of early drafts and given enough time to
consult meaningfully with their constituents and to provide written
responses. While this is not a rulemaking process, the federal authors
of the strategy and plan should be required to identify what the
stakeholder advice was and explain why it was disregarded or adopted.
Question 11.: As you all know, public health has been identified as
one of the critical infrastructures of our Nation. Have you been
included in the planning undertaken by the Department of Homeland
Security to protect the public health infrastructure? From what you
know about this work, how does it affect you in your state and local
positions? What more do you think needs to be done in this regard,
especially in advance of an influenza pandemic?
Response: NACCHO is a member of the Government Coordinating Council
of the Public Health and Healthcare sector (one of 17 identified
sectors). This work has no current impact at the local level because
the Public Health and Health Care Critical Infrastructure plan is not
functional and has no funding behind it.
Questions from the Honorable Michael T. McCaul, Ranking Member,
Subcommittee on Emerging Threats, Cybersecurity, and Science
Question 12.: At the hearing, Dr. Caldwell testified that most
hospitals operate at ``95% capacity everyday,'' and that New York is
actually reducing the number of hospital beds because of
``oversupply.''
Please see response to Question # 6 above which references the New
York State ``Berger Commission.'' The detailed report can be located at
http://www.nyhealthcarecommission.org/
Question 13.: What ability do local hospitals in your states have
to accommodate a surge that would be associated with a pandemic?
Response: Local hospitals are expected to have a surge of up to ten
percent (10%) over their normal capacity. Most local hospitals in NY
are close to that surge capacity.
Question 14.: What type of procedures are in place to increase
capacity should a pandemic occur?
The biggest concern for us is what happens when the surge is over
the proposed ten percent? What do we do when hospitals are over
capacity? Our local hospitals are in the process of developing a plan
to address that very question. We need to come up with a model to set
up alternate sites of care and that is a huge challenge for our local
healthcare systems.
Questions from the Honorable James Langevin, chairman, Subcommittee on
Emerging Threats, Cybersecurity, and Science
Responses from L. Anthony Cirillo, MD
Question 1.: The Implementation Plan for the National Strategy for
Pandemic Influenza provided this task, ``All Federal, 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''--which would have been July 2006. What
challenges do you see with executing this task?
Response: The greatest challenges to the development and
maintenance of a system to ensure the transport of influenza specimens
to reference laboratories is actually support of the labs themselves
and the development of a more efficient process for dissemination of
the information obtained from testing of influenza specimens. During a
pandemic, or even during seasonal flu, the capacity of laboratories to
process influenza specimens in a timely manner is limited by the number
of staff trained and assigned to this process. Like many other aspects
of the healthcare system, the surge capacity of the laboratories is
limited. While cross-training of lab personnel occurs, and can help to
provide short term support for increased testing demand, it provides
only limited increased capacity. Additionally, systems must be
developed for the rapid analysis and dissemination of information
obtained from testing such as geographic patterns of illness,
susceptibility to antiviral medications, appropriateness of match to
current influenza vaccine. It is critical that this information be
quickly shared with the healthcare and public health sectors for
ongoing adjustment of medical and public health interventions during a
pandemic.
Question 2.: The Implementation Plan for the National Strategy for
Pandemic Influenza states that, ``All health care facilities should
develop, test, and be prepared to implement infection control campaigns
for pandemic influenza, within 6 months'' of when the Plan was released
(deadline: October 2006). Our hospitals and other health care
facilities are more than familiar with infection control measures. Can
you describe the specific challenges in identifying and implementing
infection control measures for pandemic influenza?
Response: The challenges to instituting infection control measures
at hospitals and other healthcare facilities during a pandemic will be
due to a lack of adequate capacity of the healthcare system and the
infectious nature of influenza. In order to operate cost-effectively,
hospitals today are operating at or near their licensed inpatient bed
capacity. While this operational efficiency is financially prudent, it
may significantly limit the ability of the hospitals to efficiently
segregate patients during a pandemic. Given the increased demand for
healthcare services anticipated during a pandemic, it is likely that
all existing inpatient bed capacity will be utilized at all times.
Attempts at segregating patients with influenza from patients receiving
medical services for all other medical conditions may initially be
possible, but as the numbers of inpatients continues to surge, the need
to provide care quickly, in the next available bed, may very well
overwhelm any system designed to segregate infectious from non-
infectious patients. An additional challenge during an influenza
pandemic will be that people (including patients, staff, and visitors)
may be already infected, and contagious, prior to the development of
symptoms of influenza. So, even in the best of circumstances,
segregation of patients with demonstrated influenza illness will not
likely prevent the spread of illness to other clinical areas within a
healthcare facility. Given these realities, it is unclear if the
expenditure of resources needed to segregate patients will yield much
in the way of significant reductions in illness spread.
Question 3.: According to the Implementation Plan for the National
Strategy for Pandemic Influenza, ``The Federal Government shall, and
State, local, and tribal governments should, define and test actions
and priorities required to prepare for and respond to a pandemic,
within 6 months'' of when the Plan was released--so the deadline would
have been October 2006. What are the challenges here? Are you waiting
for the Federal government to provide you with guidance and resources?
Response: Given the worldwide nature of a pandemic by definition,
it is appropriate that the overall strategy related to the management
of pandemic be developed on a global level. However, while a global
strategy for pandemic influenza may be developed through agencies such
as the World Health Organization (WHO), the implementation of that
strategy will be different based upon the local effect of the pandemic
and the availability of supplies, medications, and personnel. Within
the United States, there will be an expectation for consistency of
care. As such, it is again appropriate that a national approach be
taken in responding to a pandemic influenza event. Thus the federal
government, especially the Centers for Disease Control and Prevention
(CDC), should take the lead in the development of standardized and
universal strategies for key aspects of pandemic influenza management.
These key aspects include issues such as prioritization of antiviral
medication and influenza vaccine distribution and guidance on
effectiveness and appropriateness of personal protective equipment
(masks, gloves, etc.). After Secretary Leavitt's visit to states during
late 2005 / early 2006, the challenge to states at that time was the
lack of guidance at the federal level on many of these key issues. Over
the past nearly two years, there have now been numerous reports, from
various agencies, on many key issues related to pandemic influenza
management. As such, the challenge for state and local public health
departments is now to continually update and revise pandemic influenza
local strategies as guidance continues to be updated at the federal
level. While updates in guidance and recommendations are necessary, and
should reflect the latest in our understanding of how to mitigate the
effects of a pandemic on society, it does require significant resources
to continue to update planning documents, and more importantly,
communicate these changes to all of the partners involved in pandemic
preparedness. Lastly, as plans continue to evolve and change, there is
a need for ongoing trainings and exercises to ensure that plans can be
effectively implemented which again, requires significant investments
of time and money at the state, local, and private sector levels.
Question 4.: According to the Implementation Plan for the National
Strategy for Pandemic Influenza, ``State, local, and tribal law
enforcement agencies should coordinate with appropriate medical
facilities and countermeasure distribution centers in their
jurisdictions to coordinate security matters, within 6 months'' of when
the Plan was released--so the deadline would have been October 2006. To
your knowledge, has any of this coordination taken place? If so, how,
and if not, how would you recommend this happen?
Response: Within Rhode Island (and many other states) coordination
of specific functions such as law enforcement /security is accomplished
in concert with the state Emergency Operations Plan (EOP) utilizing the
Emergency Support Function (ESF) delegation of functional
responsibility. In Rhode Island, the Rhode Island State Police (RISP)
serve as the lead agency for coordination of law enforcement planning
related to emergency scenarios. The Department of Health serves as the
lead agency for pandemic planning within the state by direction of the
Governor. The Director of Health, Dr. David Gifford has established the
Pandemic Flu Director's Advisory Group, comprised of key state agency
directors. The commanding officer for the Rhode Island State Police (or
his designee) attends these meetings to coordinate state agency
planning for a pandemic. The RISP are also members of the Rhode Island
Police Chiefs Association through which additional planning activities
have occurred related to pandemic flu. Lastly, the RISP also serve as
the law enforcement agency responsible for security evaluations of all
medication distribution sites under the federal Strategic National
Stockpile (SNS) program. In this capacity, they work together with law
enforcement officials in all municipalities in the identification of
appropriate facilities for distribution of medications or vaccines
during a public health emergency.
Question 5.: In your testimony, you described regional interstate
coordination in pandemic preparedness, and that the ``. .
.collaborative effort resulted in a two-day summit and multistate
tabletop exercise held to coordinate the interstate response to a
pandemic.'' Please provide additional information regarding the
regional interstate coordination and collaborative efforts you
mentioned in testimony, the two-day summit, and the multistate tabletop
exercise. What lessons have been observed and learned?
Response: As noted above in Answer #3, after Secretary Leavitt's
state visits, the states were charged with developing a comprehensive
strategy for responding to a pandemic influenza event. Within the New
England region, it was recognized that the geographic proximity of
states within the region would necessitate a collaborative approach to
pandemic influenza planning. Also as noted above, early on after
Secretary Leavitt's visits, there was limited guidance on how to
prepare for a pandemic influenza event. Given this lack of national
guidance, the six New England states and New York State began a
collaborative process to identify best and common practices among the
states. At least one representative from each state was assigned to
participate in workgroups on the following issues: Antiviral
medications, Community Containment, Mass Fatality Management,
Laboratory/Illness Surveillance, Personal Protective Equipment (PPE),
and Surge Capacity. These groups met by conference call from March
through June 2006. The work of these groups culminated in a two-day
meeting in Boston, MA on June 29th & 30th. During this meeting,
consensus assumptions, positions and planning strategies were
identified for many, although not all aspects, of pan flu planning. The
key lessons learned from these activities were delineation of common
planning assumptions including attack rates of illness, and approaches
to school closures and risk communication, especially in mass media
markets that traverse state boundaries. Another key lesson learned was
the need to integrate planning in the public health / healthcare sector
with planning efforts in the emergency management sectors. In order to
accomplish this, an exercise was hosted by the Naval War College in
Newport, RI in August 2006. The exercise brought together leaders from
each state including health care/public health, emergency management,
and the Governor's office from each state. In addition, two meetings of
the State Directors of Health were also coordinated by the Region I
Office of the US Department of Health & Human Services.
Question 6.: In your testimony, you mentioned ``. . .the
disincentives to the purchase of antiviral medications Tamiflu and
Relenza due to exclusion from the shelf-life extension program of state
health supplies of these medications.'' Please provide the Committee
with additional information regarding these disincentives, the shelf-
life extension program, etc. How do you propose this situation be
changed, understanding that the federal government is seeking to ensure
that states are preparing for pandemic influenza specifically?
Response: Antiviral medications may have a significant impact on
mitigating the effects of pandemic related illness on society. There is
however, also the possibility that current antivirals will have little
to no effect on the duration or severity of illness. It is this primary
uncertainty that makes the purchase of antiviral medications a
calculated risk for states in preparing for a pandemic influenza event.
Even more important than the development of strategies for stockpiling
and distribution in the community, is the fundamental question as to
the value of antiviral medications. Historically during seasonal
influenza outbreaks, patients who are treated very early on in their
illness course have shown a small decrease in the length and severity
of illness. However, there is no guarantee that these effects would be
seen during a pandemic influenza event, as the specific virus is
currently not known. In testing and treatment of patients infected with
H5N1 (Avian Flu), there has been only limited clinical treatment
success in reducing illness and mortality. In addition to the
uncertainty of the efficacy of antivirals during a pandemic, there is
concern about the current policy of the US Food & Drug Administration
(FDA) that does not allow for utilization of antiviral medications for
clinical treatment if the antiviral medications have reached their
expiration date. Even for states who have stored these medications in
accordance with acceptable temperature and humidity ranges, there have
been no exceptions to the strict expiration date policy. The Shelf Life
Extension Program (SLEP) was created to allow for periodic re-
verification of the potency of medications or vaccines currently held
in federal stockpiles. It is possible to expand the scope of the SLEP
program to include the caches of antivirals that states are purchasing
for a pandemic influenza event. There would need to be some
modifications to the program to allow for the manufacturers to provide
samples of each lot of medication produced to the SLEP program for
batch verification. As long as states can ensure that locally held
caches are kept at appropriate environmental conditions, then the
entire manufacturer batch would be eligible for SLEP extension.
Question 7.: In your testimony, you mentioned ``. . .it is critical
that all federal preparedness programs related to pandemic or other
public health emergencies be more closely aligned and coordinated so
that we at the state level can more effectively develop an appropriate
response to all public health emergencies.'' How do you suggest this be
accomplished by the federal government?
Response: One of the challenges facing states in their preparedness
efforts is the lack of coordination and alignment of federal grant
funding goals and objectives. Currently the US Departments of Health
and Human Services and Homeland Security are providing funding for
emergency preparedness, with a specific focus on pandemic influenza
preparedness activities. However, both between, and even within
agencies there are gaps in collaboration of grant funding and planning
priorities at the federal level. This lack of coordination, especially
within HHS, results in grant funding for the same issue, such as
pandemic influenza, with conflicting grant deliverables, performance
measures, reporting systems, and grant timelines. This lack in
coordination at the federal level results in inefficiencies in grant
management at the state level attempting to design a single pandemic
influenza planning strategy with multiple different ``asks'' from each
grant. Improved coordination must occur at the most senior level of HHS
and DHS in order for these gaps in grant planning to occur. Within HHS,
the Secretary should establish a single set of priorities and guidance
for pandemic influenza preparedness. This single set of priorities and
guidance should also be reflected in uniform definitions, performance
measures, and timelines for all pandemic influenza grant funding.
Question 8.: What roles do associations play in assisting their
constituents with emergency and pandemic preparedness?
Response: The private sector, including professional associations
and businesses will play a critical role in the successful response of
society to a pandemic event. The ability to incorporate associations
such as representatives of hospitals, nursing homes, and healthcare
professionals in pandemic influenza event will be crucial in order to
muster and coordinated existing healthcare and non-healthcare
infrastructure during a pandemic. Just as there is an added
inefficiency to coordinated planning between federal agencies, there is
a significant benefit to be gained by early involvement of other key
stakeholders.
Question 9.: The Government Accountability Office (GAO) says in its
report that State, Territorial, Tribal, Local, and other stakeholders
need to be involved in providing input to the National Strategy for
Pandemic Influenza and its Implementation Plan, especially as the
National Strategy evolves. If you were at the White House, how would
you ensure this happens?
Response: As has been mentioned above, I believe it is appropriate
for a significant portion of the guidance on best practices for
pandemic influenza preparedness to be developed at the federal level.
However, the process for the development of guidance at the federal
level must incorporate the realities of the implementation at the local
level. Therefore, it is important that federal policy makers and
subject matter experts include representatives of state, local, and
tribal entities in the development of guidance and policies regarding
pandemic influenza. The input of state, local, and tribal entities is
probably most efficiently ensured through the incorporation of
representative associations for these groups. Examples of these
associations would be groups like the Association of State and
Territorial Health Officials (ASHTO), the National Association of City
and County Health Officials (NACCHO), the National Governor's
Association (NGA) and representatives of healthcare professional
organizations like the American Medical Association (AMA) and American
Nurses Association (ANA). Since these associations and organizations
are well recognized as leaders within their respective memberships,
they can serve as a conduit of information throughout the development
and refinement of guidance and policies related to pandemic influenza.
Question 10.: As you all know, public health has been identified as
one of the critical infrastructures of our Nation. Have you been
included in the planning undertaken by the Department of Homeland
Security to protect the public health infrastructure? From what you
know about this work, how does it affect you in your state and local
positions? What more do you think needs to be done in this regard,
especially in advance of an influenza pandemic?
Response: Initially after state visit of Secretary Leavitt, the
public health sector was much more involved in the management of a
pandemic influenza event than the emergency management / Department of
Homeland Security arenas. However, there has been much recent work by
the Federal Emergency Management Agency to improve the coordination of
pandemic flu preparedness and response activities. Ongoing efforts
related to pandemic flu planning must focus on identifying
methodologies to improve the coordination of planning in a ``top down''
manner, but with inclusion of others as noted in Answer #9. Here in
Rhode Island, there has been considerable discussion between the
Department of Health and the State of Rhode Island Emergency Management
Agency regarding the protection of critical infrastructure and
maintenance of society during a prolonged pandemic event.
Questions from Honorable Michael T. McCaul, Ranking Member,
Subcommittee on Emerging Threats, Cybersecurity, and Science
Question 1.: At the hearing, you described national policies that
prohibit using medications bought on the federal contract for anything
but a pandemic. This makes the procurement of antivirals an ``at risk''
investment.
Question 2.: How do current federal regulations influence your
efforts to stockpile antiviral medications?
Question 3.: What do you see as a practical solution that would
reduce the investment risk of procuring antiviral medications while
ensuring adequate supplies of these medications are available in the
event of a pandemic?
Response: Please refer to Answer #6 above regarding antiviral
medications in response to Questions #1--3.
Questions from the Honorable Bennie G. Thompson, Chairman, Committee on
Homeland Security
Responses from B. Tilman Jolly, MD
Question 1.: What is the status of the pandemic influenza exercises
that were to be incorporated into the National Exercise Program? How
many will there be, when are they occurring, and who all will be
involved?
Response: Pandemic Influenza (PI) exercises and the Pandemic
Influenza Exercise series (PIX) remain a priority for the National
Exercise Division (NED). The first Principal-Level Exercise (PLE) of FY
2008, PLE 1-08, will focus specifically on Pandemic Influenza, and the
myriad issues associated with a PI outbreak arriving in the United
States. In support of that PLE, two Assistant Secretary-level exercises
are being conducted. The first exercise--which has already occurred--
was hosted by the State Department in October, and focused on the U.S.
response to an influenza outbreak prior to arrival in the U.S. This
exercise included 21 senior officials from 12 agencies and White House
offices. The results will inform and support the Cabinet level exercise
in 2008. A similar exercise, also at the Assistant Secretary level, is
being developed to cover issues related to an outbreak in the U.S.--and
it will also inform and support the PLE. The Homeland Security Council
is currently refining the scope of the PLE 1-08 exercise. The exercise
is scheduled to be conducted in February 2008.
In order to maximize lessons learned and address issues identified
in the conduct of PLE 1-08, the Regional Pandemic Influenza Exercises
will occur after that exercise. These exercises will take place in each
of the five PI regions identified by the Department of Homeland
Security (DHS), and will involve Regional representation (from state
and federal partners) as well as activity at the Headquarters level.
The current scope of the Regional PIX focuses on interaction between
the Regions and Headquarters, although that may shift depending upon
the lessons learned and issues identified during PLE 1-08.
FEMA Regions I and II are co-hosting both a PI workshop and a PI
functional exercise in November and December 2007 to examine the
regions' response to a PI outbreak at the local level. Further, the
Office of Health Affairs will conduct a PI Principal Federal Officials
(PFO) workshop in late November 2008 to provide the first test of
communications capabilities between Regional and National-level PFOs.
Lessons learned from each of these exercises will also be incorporated
into the PIX.
Question 2.: Two things result from exercises: (1) the
identification of actions necessary to correct problems, and (2)
lessons learned. Knowing this, the Department of Homeland Security has
created two activities--the Corrective Action Program, and the Lessons
Learned Information Sharing system (with information pushed to
LLIS.gov). After the pandemic influenza exercises have occurred as part
of the National Exercise Program, what plans are there for using the
Corrective Action Program and the Lessons Learned Information Sharing
system? How does (or will) the Office of Health Affairs work to get the
necessary information vetted and included in these programs? What part
of the Office of Health Affairs will be staying on top of the
situation, ensuring that corrective actions are taken, and that lessons
are truly learned--before a pandemic occurs?
Response: The National Exercise Program (NEP) requires the use of
the Homeland Security Exercise and Evaluation Program (HSEEP) and the
Corrective Action Program (CAP) to identify and resolve major issues
from exercises and promotes the use of Lessons Learned Information
Sharing System (LLIS) for distribution of lessons learned applicable
and appropriate to the broader emergency management community. Any
Pandemic Influenza (PI) exercises conducted within the NEP will utilize
HSEEP, CAP and LLIS as part of the After Action Report process.
(Additionally, exercises conducted outside of the NEP are encouraged to
utilize tools provided through HSEEP, CAP and LLIS.) The Department's
Office of Health Affairs (OHA) has representatives on the DHS Exercise
and Evaluation Steering Committee and has participated in the
development of the HSEEP and DHS-specific CAP procedures.
CAP is a formal process and methodology that defines the roles and
responsibilities for identification, development, prioritization,
tracking, and analysis of corrective actions following exercises or
real-world incidents that should receive consideration within the
Department or the Interagency dependent upon the issue. It is an
overarching program that refers issues to appropriate organizations--
such as the Office of Health Affairs--for priority action. The CAP
System is a web-based tool that enables Federal, State, and local
emergency response and homeland security officials to implement the CAP
process.
Since the launch of Lessons Learned Information Sharing (LLIS.gov)
in April 2004, the Department of Homeland Security has sought to raise
awareness of the program, increase membership, and encourage usage
among its desired audience of emergency response and homeland security
professionals through a coordinated outreach and awareness strategy.
These efforts have increased LLIS.gov membership to more than 40,000
professionals from all relevant disciplines, levels of government, and
all 50 states and territories.
Question 3.: What is the status of the Department of Homeland
Security's pandemic influenza implementation plan? Previously, Dr.
Runge (the Chief Medical Officer), has referred to this plan in
testimony before Congress. We understand that it has been drafted
completely, but that it is has not yet been posted to PandemicFlu.gov
or the Department's own website. Has the draft plan been circulated
throughout the Department? When do you expect that it will be
finalized? What is it that personnel throughout the Department are
working from to help the Department and the Nation prepare for an
influenza pandemic?
Response: The Department's pandemic influenza plan is in final
draft form and has been circulated throughout DHS for use in developing
component plans. We anticipate being able to revise it based upon a
final version of a Federal Strategic Plan, which has been developed by
a group led by DHS, and which is now in interagency review.
Question 4.: According to the White House, DHS was to have worked
with others to complete this action item from the Implementation Plan
for the National Strategy for Pandemic Influenza--by October 2006. The
task is, ``DOJ, DHS, and DOD shall engage in contingency planning and
related exercises to ensure they are prepared to maintain essential
operations and conduct missions, as permitted by law, in support of
quarantine enforcement and/or assist State, local, and tribal entities
in law enforcement emergencies that may arise in the course of an
outbreak, within 6 months.'' Why has this task not been completed yet?
Response: This item was extended because of the requirement for
further development of a national quarantine policy and the ongoing
interagency work being done on the Federal Pandemic Influenza Strategic
Plan and the Federal Pandemic Influenza Border Management Plan. Policy
issues surrounding quarantine are within the purview of other parts of
the Executive Branch. As these policy issues become more clear, the
operational elements can be accomplished.
Question 5.: According to the White House, DHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by December 2006. The task
is, ``DHS, in coordination with DOT, HHS, and USDA, shall conduct
tabletop discussions and other outreach with private sector
transportation and border entities to provide background on the scope
of a pandemic, to assess current preparedness, and jointly develop a
planning guide, within 8 months.'' Why has this task not been completed
yet?
Response:
The planning guide is under development as part of the broader
efforts to complete sector-specific guides for all CI/KR sectors.
Meetings with the various transportation modes are in progress. Modes
that have completed their Guidelines (evidenced by endorsement by the
Sector and Government Coordinating Councils) are: Mass Transit, Highway
and Motor Carriers, and Rail. Work with Aviation and Maritime are in
the final stages. Completion of the planning document is dependent on
Border Policy development and Border CONOPS which have not been
finalized by a collection of interagency partners.
Question 6.: According to the White House, DHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by April 2007. The task is,
``DHS and DOT, in coordination with DOD, HHS, USDA, USTR, DOL, and DOS,
shall develop detailed operational plans and protocols to respond to
potential pandemic-related scenarios, including inbound aircraft/
vessel/land border traffic with suspected case of pandemic influenza,
international outbreak, multiple domestic outbreaks, and potential mass
migration, within 12 months.'' Why has this task not been completed
yet?
Response: This item was extended and will be addressed in the
Border CONOPS that will be included as part of the interagency border
management plan currently under development pending completion of a
Federal Strategic Plan now in interagency review.
Led by OHA, DHS continues to be heavily involved in an interagency
effort that is currently finalizing a Federal strategic level pandemic
influenza plan. When completed, this plan will effectively outline the
roles, responsibilities and possible courses of action of all federal
departments and agencies in preparing for and responding to a pandemic.
An integral component of the strategic plan dealing with the complex
issues involved in attempting to delay the entry of a pandemic through
a variety of border management measures, has been completed by a
separate interagency working group led by the IMPT and is currently
undergoing internal review. There are several complex federal policy
decisions involving issues such as screening and possible quarantine of
passengers and potential diversion of flights pending, that impact the
private sector. Engagement with the private sector has begun, a full
review of operational and economic impacts need to be determined in
order to finalize both plans. The goal is to have both plans completed
prior to a principals level pandemic exercise that has been tentatively
scheduled for mid February 2008. Once finalized, the federal strategic
plan, incorporating the border management annex, will meet all the
performance measures of the referenced action item(s).
Question 7.: According to the White House, DHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by April 2007. The task is,
``DOT and DHS, in coordination with HHS, USDA, and transportation
stakeholders, shall develop planning guidance and materials for State,
local, and tribal governments, including scenarios that highlight
transportation and border challenges and responses to overcome those
challenges, and an overview of transportation roles and
responsibilities under the NRP, within 12 months.'' Why has this task
not been completed yet?
Response: This item was extended and will be included as part of
the interagency border management plan currently under development.
Additionally, DOT and DHS POCs convened a working group to include
transportation stakeholders, HHS and USDA. The group identified
multiple documents that provide tailored guidance and planning
materials that are available to state, local, and tribal governments as
well as transportation stakeholders. Transportation roles and
responsibilities are outlined in the NRP Emergency Support Function
#1--Transportation Annex. The NRP has been widely distributed to
stakeholders. Examples of documents are:
1. The Role of Law Enforcement in Public Health Emergencies
(September, 2006); DOJ: Bureau of Justice Assistance; 38 pp.
Challenges addressed include: responding to and managing
incidents; risks to Law Enforcement to disease; immunization
and PPE; protecting the community; Law Enforcement's role
during involuntary restrictions, including quarantine; and
other subject areas.
2. HHS Pandemic Influenza Plan supplement 9: managing travel-
related risk of disease transmission; 16 pp. Challenges
addressed include: Engaging community partners; protocols for
managing ill passengers at ports of entry; quarantine
preparedness at ports of entry; legal preparedness; and others.
3. DHS: Pandemic Influenza: Preparedness, Response, and
Recovery; Guide for Critical Infrastructure and Key Resources
(June 21, 2006) 84 pp. Challenges addressed include:
recommendations for planning, preparedness, response and
recovery for businesses (transportation sector is one of the
primary CI/KR elements); assessment recommendations on the
risks, impacts, and implications of pandemic-related
disruptions to international production, supply chain, and
goods and personnel movement; border challenges; and others.
4. DOL: Guidance on Preparing Workplaces for an Influenza
Pandemic (OSHA 3327-02N 2007); 44 pp. This document provides
guidance to all stakeholders to meet the following Pandemic
Influenza challenges that directly relate to the transportation
sector and border issues: how Influenza Can Spread Between
People; classifying Employee Exposure to Pandemic Influenza at
Work; How to Maintain Operations During a Pandemic; How
Organizations Can Protect Their Employees; The Difference
Between a Surgical Mask and a Respirator; Steps Every Employer
Can Take to Reduce the Risk of Exposure to Pandemic Influenza
in Their Workplace.
Question 8.: According to the White House, DHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by April 2007. The task is,
``DOT and DHS, in coordination with HHS, DOD, DOS, airlines/air space
users, the cruise line industry, and appropriate State and local health
authorities, shall develop protocols to manage and/or divert inbound
international flights and vessels with suspected cases of pandemic
influenza that identify roles, actions, relevant authorities, and
events that trigger response, within 12 months.'' Why has this task not
been completed yet?
Response: This item was extended and will be included as part of
the interagency border management plan currently under development
pending completion of the Federal Strategic Plan now in interagency
review.
Led by the IMPT and coordinated by DHS/OHA, an interagency working
group has completed a draft pandemic influenza border management plan
that will be an integral component to the overall federal strategic
pandemic influenza plan. While a draft plan has been completed, there
are several complex federal policy decisions that have yet to be
resolved. These areas include the screening and possible quarantine and
isolation of ill passengers or passengers suspected of being exposed to
pandemic influenza; and the possible denial of entry into the US of
non-resident aliens during a pandemic. These complex federal policy
decisions impact the private sector. Engagement with the private has
begun, a full review of operational and economic impacts need to be
determined. Interagency groups, in conjunction with and coordinated by
sub-PCC and PCCs, continue to work towards finalizing these issues.
Once finalized, the federal strategic plan , incorporating the border
management annex, will meet all the performance measures of the
referenced action item(s).
Question 9.: According to the White House, DHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by December 2006. The task
is, ``HHS, DHS, and DOT, in coordination with DOS, DOC, Treasury, and
USDA, shall develop policy guidelines for international and domestic
travel restrictions during a pandemic based on the ability to delay the
spread of disease and the resulting health benefits, associated
economic impacts, international implications, and operational
feasibility, within 8 months.'' Why has this task not been completed
yet?
Response: This item was extended and will be included as part of
the interagency border management plan currently under development
pending completion of the Federal Strategic Plan now in interagency
review.
Led by the IMPT and coordinated by DHS/OHA, an interagency working
group has completed a draft pandemic influenza border management plan
that will be an integral component to the overall federal strategic
pandemic influenza plan. While a draft plan has been completed, there
are several complex federal policy decisions that have yet to be
resolved. These areas include the screening and possible quarantine and
isolation of ill passengers or passengers suspected of being exposed to
pandemic influenza; and the possible denial of entry into the US of
non-resident aliens during a pandemic. These complex federal policy
decisions impact the private sector. Engagement with the private has
begun, a full review of operational and economic impacts need to be
determined. Interagency groups, in conjunction with and coordinated by
sub-PCC and PCCs, continue to work towards finalizing these issues.
Once finalized, the federal strategic plan , incorporating the border
management annex, will meet all the performance measures of the
referenced action item(s).
Question 10.: According to the White House, DHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by February 2007. The task
is, ``DHS, DOT, and HHS, in coordination with transportation and border
stakeholders, and appropriate State and local health authorities, shall
develop aviation, land border, and maritime entry and exit protocols
and/or screening protocols, and education materials for non-medical,
front-line screeners and officers to identify potentially infected
persons or cargo, within 10 months.'' Why has this task not been
completed yet?
Response: This item was extended and will be included as part of
the interagency border management plan currently under development
pending completion of the Federal Strategic Plan now in interagency
review.
Led by the IMPT and coordinated by DHS/OHA, an interagency working
group has completed a draft pandemic influenza border management plan
that will be an integral component to the overall federal strategic
pandemic influenza plan. While a draft plan has been completed, there
are several complex federal policy decisions that have yet to be
resolved. These areas include the screening and possible quarantine and
isolation of ill passengers or passengers suspected of being exposed to
pandemic influenza; and the possible denial of entry into the US of
non-resident aliens during a pandemic. These complex federal policy
decisions impact the private sector. Engagement with the private has
begun, a full review of operational and economic impacts need to be
determined. Interagency groups, in conjunction with and coordinated by
sub-PCC and PCCs, continue to work towards finalizing these issues.
Once finalized, the federal strategic plan , incorporating the border
management annex, will meet all the performance measures of the
referenced action item(s).
Question 11.: According to the White House, DHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by February 2007. The task
is, ``DHS and HHS, in coordination with DOT, DOJ, and appropriate State
and local health authorities, shall develop detection, diagnosis,
quarantine, isolation, EMS transport, reporting, and enforcement
protocols and education materials for travelers, and undocumented
aliens apprehended at and between Ports of Entry, who have signs or
symptoms of pandemic influenza or who may have been exposed to
influenza, within 10 months.'' Why has this task not been completed
yet?
Response: This item was extended and will be included as part of
the interagency border management plan currently under development
pending completion of the Federal Strategic Plan now in interagency
review.
Led by the IMPT and coordinated by DHS/OHA, an interagency working
group has completed a draft pandemic influenza border management plan
that will be an integral component to the overall federal strategic
pandemic influenza plan. While a draft plan has been completed, there
are several complex federal policy decisions that have yet to be
resolved. These areas include the screening and possible quarantine and
isolation of ill passengers or passengers suspected of being exposed to
pandemic influenza; and the possible denial of entry into the US of
non-resident aliens during a pandemic. These complex federal policy
decisions impact the private sector. Engagement with the private has
begun, a full review of operational and economic impacts need to be
determined. Interagency groups, in conjunction with and coordinated by
sub-PCC and PCCs, continue to work towards finalizing these issues.
Once finalized, the federal strategic plan , incorporating the border
management annex, will meet all the performance measures of the
referenced action item(s).
Question 11.: Please provide us with information regarding the
changes in ESF-8 from the National Response Plan to the National
Response Framework. What impact will these changes--and any others in
other parts of the National Response Framework--have on the pandemic
influenza plans you already have in place?
Response: The goals and objectives of ESF-8, and pandemic influenza
plans, remain essentially unchanged under the National Response
Framework. The need to work within an organized national structure, led
by the Secretary of Homeland Security, working in close partnership
with ESF-8 and others is still critical.
Question 13.: How does the National Strategy for Pandemic Influenza
relate to and work with the National Strategy for Homeland Security?
Response: A detailed analysis of these documents is beyond the
scope of the answer to a single question. However, pandemic influenza,
particularly severe instances, represents a threat to the homeland in
much the same way that other threat scenarios do. These strategic
documents work in concert and in concert with other key planning
documents.
Question 14.: In his testimony, Dr. Jolly stated that, ``. . .DHS
is currently leading the development of specific guides for each of the
17 critical infrastructure and key resource sectors using the security
partnership model.'' Please describe the security partnership model and
how it is being applied to develop these guides. What is the status of
these guides--when will they be completed? If they are available now,
please forward them to the Committee staff.
FACT SHEET
SECTOR-SPECIFIC PANDEMIC INFLUENZA PLANNING GUIDELINES
The Guidelines are the product of collaboration between the
Department of Homeland Security's Partnership and Outreach Division
(POD) and the 17 Critical Infrastructure and Key Resource (CI/KR)
Sectors. The Guidelines are part of an effort to develop Sector-
Specific Pandemic Planning Guidelines for all 17 of the Nation's CI/KR
Sectors. These Guidelines are an annex to the Pandemic Influenza
Preparedness, Response, and Recovery Guide for Critical Infrastructure
and Key Resources (CI/KR Pandemic Influenza Guide), and have been
designed to assist owners and operators within each Sector to plan for
a catastrophic pandemic.
The Guidelines are the next practical step in the ongoing
requirement of the Department of Homeland Security (DHS) to support and
facilitate effective pandemic preparedness and partnerships with the
public and private sectors. The Implementation Plan for the National
Strategy for Pandemic Influenza articulates the requirement for these
Guidelines in task 9.1.2.1, which specifies:
``DHS, in coordination with Sector-Specific Agencies, critical
infrastructure owners and operators, and States, localities and
tribal entities, shall develop sector-specific planning
guidelines focused on sector-specific requirements and cross-
sector dependencies.''
Purpose of Guidelines
The Guidelines serve as a non-prescriptive reference
and a practical tool that business continuity planners can use
to augment and tailor their existing emergency response plans
to the exceptional challenges specific to a pandemic outbreak.
It is important to integrate these Guidelines with
existing business continuity and emergency response plans and/
or the CI/KR Pandemic Influenza Guide's comprehensive framework
for pandemic catastrophic planning.
Guideline Development Process within the Sector Partnership
Framework
Given the potentially extreme consequences a severe pandemic could
have on our Nation's economic and social stability, the importance of
strong public-private sector partnerships in our preparedness efforts
has never been more important. The POD pandemic support team is eager
to work with you to develop practical and useful tools to assist you
with pandemic influenza planning.
The POD pandemic support team worked closely with the
Sector-Specific Agency (SSA), Sector Coordinating Council
(SCC), and Government Coordinating Council (GCC) of the Sector
to develop a concise document that captures the sector-specific
planning challenges a sector may face during a pandemic
influenza outbreak.
The team's first step was to work with subject matter
experts identified by each sector to learn more about the
unique operational and structural characteristics of the
sector.
With that input in hand, the team then developed a
draft Guideline and distributed it to the membership of the SCC
and GCC for formal review and comment.
Each of the guidelines is being developed within the Sector
Partnership Framework (also known as the Sector Partnership Model),
which is outlined in the National Infrastructure Protection Plan
(NIPP). The goal of the Sector Partnership Framework, including all of
its associated structures, partnerships, and information-sharing
networks, is to establish the context, framework, and support for
activities required to implement and sustain the national CI/KR
protection effort.
The framework is the primary organizational structure for
coordinating CI/KR efforts and activities. The Sector Partnership
Framework encourages formation of SCCs and GCCs as described above. DHS
also provides guidance, tools, and support to enable these groups to
work together to carry out their respective roles and responsibilities.
SCCs and corresponding GCCs work in tandem to create a coordinated
national framework for CI/KR protection within and across sectors. The
POD Pandemic team has worked closely with representatives of each SCC
and GCC in the development, review, and endorsement of each Sector-
Specific Guideline. Additionally, as noted above, each SCC and GCC
formally jointly reviews and endorses their Sector guideline.
Guideline Development Status Report
The guidelines are being developed with a four-phase guideline
development process:
Phase One--Research and Create a Draft Review
Guideline: In collaboration with the appropriate SSA/SCC/GCC
representatives, the DHS teams will develop for each CI/KR
sector a draft Sector-specific Review Guideline.
Phase Two--Formal SSA/SCC/GCC Review and Development:
the DHS teams will engage with each sector's SSA and SCC/GCC to
formally evaluate, enhance and endorse their sector's draft
review guideline.
Phase Three--Workshop: with a sector endorsed
Guideline complete a CI/KR Guide and COP-E Update and Sector-
specific Guideline Workshop(s).
Phase Four--Distribute Final Approved Guidelines and
Post at Websites: after completing reviews and receiving formal
approval, DHS will distribute through the SSA and SCC/GCC to
the sectors and post on federal websites.
There are 22 guidelines covering all 17 CI/KR Sectors, and there
are currently drafts for each of these documents in various stages of
development, as noted below. DHS anticipates posting all 22 guidelines
on www.pandemicflu.gov and www.ready.gov in March 2008.
1. Banking and Finance, Phase 1
2. Chemical, Phase 2
3. Commercial Facilities, Phase 3
4. Communications, Phase 3
5. Dams, Phase 3
6. Defense Industrial Base, Phase 1
7. Emergency Services, Phase 1
8. Energy
a. Oil and Natural Gas, Phase 3
b. Electricity, Phase 3
9. Food and Agriculture, Phase 2
10. Government Facilities, Phase 1
11. Information Technology, Phase 3
12. National Monuments and Icons, Phase 1
13. Nuclear, Phase 3
14. Postal and Shipping, Phase 1
15. Public Health and Healthcare, Phase 2
16. Transportation
a. Aviation, Phase 1
b. Highway Motor Carrier, Phase 3
c. Maritime, Phase 2
d. Mass Transit, Phase 3
e. Railroad, Phase 3
17. Water, Phase 3
Question 15.: In his testimony, Dr. Jolly stated that, ``. . .DHS
is developing a coordinated government-wide planning forum.'' Please
provide specifics regarding this planning forum. How is coordinated?
Which governmental agencies participate? What does the forum produce?
How often does it meet?
Response: DHS is working within a construct that is coordinated by
the Incident Management Planning Team, within the Operations
Directorate. This interagency body is working to develop strategic
plans for all threat scenarios. Subject matter expertise from within
DHS guides the process, and participants include all departments and
agencies involved in preparedness and response for each issue. This
group works in various forms every day to developing these plans.
Question 16.: In his testimony, Dr. Jolly stated that, ``an initial
analysis of the response requirements for federal support has been
completed.'' Please describe this analysis, and highlight its findings
(providing the actual analysis is also sufficient to answer this
question).
Response:
a. The Office of Health Affairs (OHA) in close coordination
with the Department of Homeland Security's (DHS) Incident
Management Planning Team (IMPT) has developed a Federal
Pandemic Influenza Strategic Plan.
b. The Federal Pandemic Influenza Strategic Plan is the
distillation of over six months of planning development which
included an interagency review of the plan by over 53 different
Federal Departments and Agencies. Over 2,500 comments were
received and integrated into the final draft of this plan. The
final draft of this plan is projected to be submitted to the
Homeland Security Council (HSC) for review/approval NLT
December of 2007.
c. This plan was developed following the five phase process
established in the National Planning and Execution System
(NPES). The figure below highlights the NPES Incident Decision
Making Process that was utilized to develop the plan.
National Planning and Execution System (NPES)
Incident Decision Making Process
.................................................. Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Understanding
.................................................. \01\ Mission \02\ Mission \04\ COA \07\ Plan/Order \09\ Plan
Identification Analysis Analysis Preparation Refinement
.................................................. \03\ COA \05\ COA \08\ Rehearsal
Development Comparison
.................................................. \06\ COA
Approval
Contingency (Deliberate) Planning Process
Figure 1. NPES IDMP Process
d. This process requires extensive analysis during each phase
of the plan development. For example, over 30 different guest
speakers and 22 separate interagency meetings were conducted
during the mission analysis phase of the process.
e. The current final draft of the plan identifies Federal
support requirements at the strategic level. This plan is over
50 pages long with hundreds of supporting pages (to include
multiple briefings) of supporting analysis. The Federal
Pandemic Influenza Strategic Plan is the result of the analysis
and provides the Federal response during each of the seven
Federal Pandemic Influenza Stages identified in the Pandemic
Influenza Implementation Plan.
Question: In his testimony, Dr. Jolly stated that, ``. . .a
national plan defining the federal concept for coordinating response
and recovery operations during a pandemic has been developed and will
be undergoing interagency review.'' Please describe this national plan.
What is the federal concept for coordinating response and recovery
operations during a pandemic? What is the status of the interagency
review--when do you expect that it will be completed? (Providing the
plan is sufficient to both describe the plan and answer the question
regarding the federal concept.)
Response: This national plan provides strategic level guidance that
identifies key responsibilities and requirements across the Federal
government. The federal concept relies on the construct outlined in the
National Response Plan, the National Response Framework, HSPD-5, and
other documents. As Secretary Leavitt and others have pointed out,
overall response and recovery will also depend heavily on actions at
the state and local level, due to the expected nature of a pandemic.
The plan has been submitted for interagency review, which is a complex
process. We continue to encourage a complete and efficient review
process, but cannot predict precisely when this review process will
conclude.
Question: In his testimony, Dr. Jolly stated that, ``. . .a
coordinated federal border management plan has been developed and is
currently under review. This process included a wide range of
partners.'' Please describe this border management plan. Who were the
partners that helped to develop this plan? What is the status of the
review--when do you expect that it will be completed? Who is conducting
this review? (Providing the plan is sufficient to both describe the
plan and answer the question regarding the federal concept.)
Response: This border management plan provides strategic guidance
for managing issues at our border during a pandemic, and identifies
capabilities required to carry out that guidance. Partners included all
departments and agencies involved in preparedness for this issue, along
with representatives of state, county, and local public health, and
public health laboratories. The plan is under review by the DHS
Incident Management Planning Team, an interagency body. Wider review is
pending review of the broader Federal Strategic Plan, now undergoing
interagency review.
Question 19.: What are the five regions to which the pre-designated
regional PFOs and deputy PFOs are assigned? Do these personnel
physically reside in these regions? If not, why not?
Response:
The five regions to which Principal Federal Officials (PFOs) and
Deputy PFOs are assigned:
Region A consists of Standard Federal Regions I and II:
CT, MA, ME, NH, RI, VT, NJ, NY, PR and VI.
Region B consists of Standard Federal Regions III and IV:
DE, DC, MD, PA, VA, WV, AL, FL, GA, KY, MS, NC, SC and TN.
Region C consists of Standard Federal Regions V and VIII:
IL, IN, MI, MN, OH, WI, CO, MT, ND, SD, UT and WY.
Region D consists of Standard Federal Regions VI and VII:
IA, KS, MO, NE, AR, LA, NM, OK and TX.
Region E consists of Standard Federal Regions IX and X:
AZ, CA, HI, NV, AK, ID, OR, WA, AS, GU, MP, FM, MH, and PW.
The PFOs and Deputy PFOs reside in the region to which they are
assigned.
Question 20.: In his testimony, Dr. Jolly stated that, ``. . .the
PFO teams have begun outreach both nationally and in their regions in
advance of the more formalized exercise program being developed by
DHS.'' Please describe these outreach efforts, as well as the more
formalized exercise program being developed by DHS. Who is responsible
for developing this program? When do you expect that this more
formalized exercise program will be implemented?
Response: The PFO teams have been participating in various state,
local and regional Pandemic Influenza workshops sponsored by the
Association of State and Territorial Health Officials (ASTHO), the
National Governors Association, and HHS. The most recent outreach
involved observing the CDC Internal Pan Flu Exercise in August 2007 in
Atlanta, GA. The Regional PFOs have also taken opportunities to meet
with some of the state governors to discuss issues related to PI
preparedness and response efforts.
The FEMA National Exercise Program is responsible for planning,
coordinating, and developing exercises related to Pandemic Influenza in
coordination with DHS Operations Coordination (the Program Manager),
the Office of Health Affairs, and the National PFO Team headed by VADM
Crea. The Pandemic Influenza PFO Teams are scheduled to conduct an
internal exercise on 27 Nov 2007 involving the Regional PFO Teams
operating from their pre-designated Joint Field Office locations and
communicating the appropriate situational reports to the National PFO
Team at the National Operations Center. The teams will also be given
specific exercise scenarios and injects that are specific to their
regional Area of Responsibility.
Question 21.: In his testimony, Dr. Jolly stated that, ``on an
ongoing basis, DHS participates in interagency working groups to
develop guidance, including community mitigation strategies, medical
countermeasures, vaccine prioritization and risk communication
strategies.'' Which interagency working groups does DHS participate in?
Please provide a comprehensive list.
Response: DHS participates on an ongoing basis on workgroups
addressing a list of pandemic issues, including community mitigation,
medical countermeasures, vaccine prioritization, and border management,
along with other less formal groups that address specific issues as
they arise.
Interagency committees that DHS (specifically OHA) participates in
include:
Pandemic Influenza Strategic Guidance Planning Process
Border Management IMPT Process
Pandemic Influenza Vaccine Prioritization Interagency
Work Group (as co-lead)
Pandemic Influenza Antiviral Household Prophylaxis
Work Group
Antiviral Drug Stockpiling by Employers in Preparation
for an Influenza Pandemic Work Group
State Panflu Operational Plans Workgroup
DHS Human Capital Pandemic Planning Work Group
HHS/ASPR PanFlu Risk Management Steering Committee
Question: In answering to a question from Rep. Langevin (During a
pandemic, when would the Secretary of Homeland Security lead and when
would the Secretary of Health and Human Services lead?), Dr. Jolly
stated that, ``. . .under the construct, the Secretary of Homeland
Security is responsible for overall domestic preparedness and incident
coordination at the federal level and would lead the overall federal
activities, while the Secretary of Health and Human Services led the
health and medical response. . . '' Please describe--using scenarios as
you see fit--when the Secretary of Homeland Security and the Secretary
of Health and Human Services would execute the responsibilities
articulated by Dr. Jolly in his testimony, and lead various efforts
during the response to an influenza pandemic.
Response: As stated in my testimony, and consistent with the
National Response Plan, the National Response Framework, HSPD-5, and
other guiding documents, The Secretary of Homeland Security and the
Secretary of Health and Human Services will fulfill these specific
duties. During a pandemic, which would likely have wide-ranging and
severe effects, the Secretary of Homeland Security would serve as the
leader of the federal response, coordinating activities of all
departments and agencies working through the ESF structure. The
Secretary of the Health and Human Services will fulfill the major
responsibility of overseeing the public health and medical response as
outlined by RADM Vanderwagen.
Question: How is DHS trying to bring its grants into the same time
sequence as the HHS grants? How is it trying to harmonize the DHS and
HHS grants? Is DHS trying to do this with the grants put out by any
other member of the Executive Branch? If so, which departments and
agencies?
Response: In June 2005, DHS and the U.S. Department of Health and
Human Services (HHS) established a Joint Grant Program Steering
Committee to facilitate the integration of preparedness activities
across State and local preparedness programs managed by both
Departments. This committee is staffed by key program offices from both
Departments, including the DHS Grant Programs and National Preparedness
Directorates within FEMA and the Office of Health Affairs in the
National Protection and Programs Directorate, and the HHS Office of the
Assistant Secretary for Preparedness and Response, the Centers for
Disease Control and Prevention, and the Office of the Surgeon General.
The mission of this grants coordination committee supports
requirements outlined in the White House Federal Response to Hurricane
Katrina: Lessons Learned report as well as the newly issued Homeland
Security Presidential Directive 21: Public Health and Medical
Preparedness, which directs the Secretary of Health and Human Services,
in coordination with the Secretary of Homeland Security, to develop and
maintain processes for coordinating Federal grant programs for public
health and medical preparedness using grant application guidance,
investment justifications, reporting, program performance measures, and
accountability for future funding in order to promote cross-sector,
regional, and capability-based coordination.
Through this committee and ongoing coordination among program
offices, DHS and HHS will continue to work with State and local
applicants to support and, where possible, integrate preparedness
activities regarding programs managed by both Departments. This
includes supporting a range of activities that are achieved through
collaboration at the State and local level among public safety,
emergency management, health and medical communities, and non-
governmental entities, such as:
Developing clear public health emergency plans that
delineate who will do what during each stage of the response
Identifying the specific competencies needed to
complete the tasks associated with the operational plan
Implementing effective training programs that
specifically support the competencies related to the public
health emergency plan
Conducting joint exercises to meet multiple
requirements from various grant programs
Engaging special needs populations and/or those who
represent them in preparedness planning and exercise activities
Conducting joint training for local decision-makers
(including government administrators, health and medical
professionals, and emergency managers) on issues of joint
concern, such as pandemic flu preparedness or risk
communication
Given that the application periods and allowable activities are
frequently driven by statutory provisions, the alignment of application
deadlines and award cycles is a longer-term issue that must be
carefully considered by both Departments. However, emphasizing a
coordinated approach to programmatic activities under the grants,
particularly those that may overlap across Departments, is a primary
focus of the grant steering committee's work and the guidance
development process for all relevant components.
Question 24.: In his testimony, Dr. Jolly stated that ``. . .we
have plans within our Principal Federal Officials group to exercise
within that group and then lead that into a series of leadership level
interagency exercises and to culminate in another cabinet-level
exercise over a period of time as the schedule develops.'' What are
these plans? When will the PFO group be exercised? When is the series
of leadership level interagency exercise scheduled to occur? When will
the next cabinet-level exercise occur?
Response: The plans refer to the PFO Team exercise workshop being
conducted November 27, 2007. The PFO Team for Pandemic Influenza
Response conducted an exercise workshop on November 27, 2007. It served
as an internal communication and information exchange exercise
involving the regional teams operating from their pre-designated Joint
Field Office locations, and the National PFO operating from the
National Operations Center. The findings from this first exercise will
be the basis for additional training and exercise venues for the PFO
teams.
The FEMA National Exercise Program is working actively with the
White House Homeland Security Council's Planning, Training, Exercise
and Evaluation Council (PTEEC) Policy Coordination Committee (PCC) on
both an Assistant-Secretary Level and Principals-Level Exercise for
Pandemic Influenza. The Cabinet level exercise is scheduled for
February, 2008.. A series of exercises are expected for development
over the next few years. The FEMA National Exercise Program, lead by
Mr. Jim Kish, and the PTEEC PCC is developing the schedule and details
for the next exercise. Mr. Kish can be contacted at 202 786-9580.
Question 25.: Can the National Biosurveillance Integration System
(NBIS) be used to track seasonal influenza now, treating the disease as
if it were pandemic influenza? Is this occurring now? If not, what
other proxy diseases is NBIS using to continuously stress the System
and ensure it will be ready (or as ready as possible) when an influenza
pandemic does occur?
Response: NBIS currently tracks seasonal influenza with specific
attention to any warning signs of a potential or actual pandemic event.
The monitoring, within the Center (National Biosurveillance Integration
Center), utilizes subject matter experts and epidemiologic strategies
in conjunction with our National Biosurveillance System Group (NBSG)
partners in accordance with its biosurveillance mission. Principle
responsibility in tracking seasonal influenza and monitoring for
pandemic influenza lies with our NBIS interagency partner, Department
of Health and Human Services, who is also a member of the NBSG.
NBIS uses the System on a 24/7 basis to track major diseases events
on a worldwide basis to proactively maintain a readiness posture.
Notification procedures, for routine and urgent issues, are regularly
utilized to maintain situational awareness with senior leadership and
key stakeholders within DHS and the interagency partners.
Question: What is the current status of NBIS? How long will it take
before you feel that NBIS will be able to function well enough to track
the beginnings of an influenza pandemic? What else is necessary to get
NBIS to the fully functional state that you envision?
Response: NBIS, as a total, integrative, collaborative system of
interagency inputs and surveillance systems with supportive IT
structure is expected to reach its Initial Operating Capability (IOC)
this January. It is scheduled to reach its Full Operating Capability
(FOC) in September, 2008, pursuant to Public Law 110-53. The National
Biosurveillance Integration Center (NBIC) is fully operational now with
two specific analytic elements: a 24-hour a day 7-day a week Watch Desk
manned by U.S. Public Health Service officers located within the
Department's National Operations Center and a select group of full-time
subject matter experts/analysts including NBIC's first interagency
detailee (a senior epidemiologist from the Center for Disease Control).
This combined effort provides round-the-clock receipt and assessment of
over 350 varied sources of information to track and examine ongoing
bio-events occurring globally in multiple domains, and the ability to
determine relative significance to homeland security. Via our partner
agencies with whom we have Memorandums of Understanding (HHS, DoD, ,
USDA, DOI, and State Dept) as well as our internal DHS components, the
NBIC is capable of receiving and responding to events and tracking
information that is currently provided by the primary responsible
agencies, as part of this developing interagency system. To reach full
functional capability we still require the final integration and
testing of the NBIS 2.0 SBU IT System (scheduled for initial
operational capability in January 2008), increased integration of
existing information streams from MOU agencies, and detailing of
Subject Matter Experts from the primary domains of interest--all of
which is addressed in the Implementing Recommendations of the 9/11
Commission Act of 2007 (PL-110-53).
Questions from the Bennie G. Thompson, Chairman, Committee on Homeland
Security
Responses from David L. Lakey, MD
Question 1.: Please describe how the academic centers interact with
the State Department of Health in Texas. How can this interaction be
improved in advance of a pandemic?
Response: The Texas Department of State Health Services
(DSHS) interacts with academia on public health emergency preparedness
issues on several levels.
DSHS has several forums for communication with the
academic health science centers located in Texas. Three members
of the DSHS Preparedness Coordinating Council (PCC), which is
the Commissioner's statewide advisory committee on
preparedness, are from academic health science centers. In
addition, several years ago DSHS formed the Academic Senior
Advisory Forum on Public Health Preparedness that includes
representatives from academic institutions across the state as
members. This group, which meets every six months, serves in an
advisory capacity to the Commissioner of State Health Services
regarding health and medical preparedness.
DSHS also works collaboratively with the two Centers
for Public Health Preparedness in Texas, located at Texas A&M
University and at the University of Texas at Houston.
Representatives of these institutions work with DSHS to ensure
coordination of strategic planning and implementation of
activities in order to maximize use of federal funds provided
to Texas.
Following Hurricanes Katrina and Rita, DSHS made a
concerted effort to ensure that all 10 of the state's academic
health science centers and approximately 100 schools of nursing
were connected with and included in their respective local
emergency management infrastructures. DSHS has also engaged
colleges and universities that have allied ancilliary and
health practice majors and/or programs, including social work,
veterinarian and pharmacist programs.
During the 2005 response to Hurricanes Katrina and
Rita, a remarkable collaboration developed DSHS and the
academic institutions When Houston was designated as the
receiving site for Louisiana residents evacuating New Orleans,
medical, civic and academic leaders worked diligently to open
medical shelters in Houston's two civic arenas; in a short time
they established a comprehensive medical triage, treatment and
in-patient presence to support medical needs of those Louisiana
residents. Similarly, in College Station, Texas A&M's School of
Veterinarian Medicine cleared out, cleaned, disinfected, and
opened for human use their large animal hospital. This facility
housed several hundred medical evacuees from the Houston--
Beaumont area of Texas who left in the face of Rita. In the
Panhandle of Texas, Texas Tech University Health Science Center
staff and residents established an in-patient treatment
facility at the former Reese AFB, while in Tyler, the
University of Texas Health Science Center cared for medical
special needs persons in the local community college gym.
Schools of nursing, pharmacy, mental health and other academic
programs contributed significant support to state-wide efforts
to assist with medical needs of evacuees.
The DSHS Regulatory Division has been working with the
Executive Chancellor for Health Affairs of the University of
Texas System on new ways to enhance DSHS' capacity to respond
effectively to emergent public health and medical situations.
Current plans include increasing the number UT of School of
Nursing Graduate Students working with preceptors in DSHS on
specific projects.
DSHS interaction with Academic Health Centers could be
improved in advance of a pandemic by documenting potential
response roles and activation plans in the following
categories:
Diagnostic capabilities and ``surge capacity;''
Mass dispensing, triage, and care;
Emergency-event enhanced surveillance;
Emergency hotline support;
Just-in-time training;
Expert consultation; and
Forum for consideration of unique therapies Media
resources.
Question 2.: You advocate an all-hazards approach, which includes
pandemic influenza, for public health emergency preparedness. Please
describe how the unique characteristics of different hazards are
addressed by planning efforts. Specifically, how does planning for an
influenza pandemic differ from all of the other hazards?
Response:
DSHS advocates an all hazards approach for public
health preparedness because core public health can and should
be applied to any type of emergency incident, whether it
qualifies as a public health emergency or not.
Core public health include:
Monitoring health status to identify community
health problems;
Diagnosing and investigating health problems
and hazards in the community;
Informing, educating, and empowering people to
take action about health issues;
Enforcing laws and regulations that protect
health and ensure safety; and
Linking people to needed personal health
services and assuring provision of health care when
otherwise unavailable.
In Texas, the responsibility to develop or support
emergency response plans is assigned to the Governor's Division
of Emergency Management (GDEM). Public health professionals
participate in planning initiatives at all jurisdictional
levels. Hazard and vulnerability assessment is a key step in
the plan development process, and when a health impact is
anticipated, DSHS explores a potential response role for public
health.
Since it is anticipated that pandemic influenza will
occur in multiple waves of illness, a lengthy, sustained
response and recovery operation will be required. It is likely
that over the course of the pandemic up to 50 percent of the
workforce may be absent due to illness, caretaking
responsibilities, fear of contagion, and loss of public
transportation or imposition of public health disease control
measures. Consequently, DSHS is working in Texas to engage non-
traditional public health partners who know most about critical
public infrastructure in planning for continuity of business
operations.
Because absenteeism over the course of the pandemic
will be high, state employees might be cross trained to provide
essential services and functions at state agencies besides
their own place of employment. Therefore, continuity of
operations planning during a pandemic must address the HR
issues that need to be handled uniformly across state agencies.
Response to most hazards is quick decontamination and
recovery. The response to a pandemic influenza outbreak will be
to mitigate the overall impact with strategies to reduce
mortality and morbidity, to flatten the outbreak curve thereby
reducing the peak of illnesses and buy time in order to produce
vaccine and to maintain continuity operations over a longer
period of time.
Due to the extended nature of pandemics when compared
to disasters of limited duration, like an explosion or 3-day
flood, the response to the former is more complex. These may
include a huge volume of resources to be managed, potential
school closures, along with early warning and public messaging
challenges.
Question 3.: From the public health perspective, there are certain
similarities and differences between disasters and pandemics. Please
describe a few of both, and talk about the implications you see for
federal support from both the Department of Homeland Security and the
Department of Health and Human Services
Response: Disasters tend to be limited in scope to a
certain area while pandemics tend to have widespread geographic impact.
Disasters themselves tend to have a short duration
followed by a variable recovery period. Pandemics tend to last
for several months with multiple waves lasting several weeks
each. Timing of an interim recovery period for a pandemic is
critically short and unpredictable and the overall recovery
period may take years.
In disasters, material loss predominates while in
pandemics human loss does.
Those responding to disasters can count on local
material aid and state/federal response. During a pandemic,
response is local; state/federal response may be very limited.
To receive adequate support, the following are needed:
Conducting studies to guide preparedness and
response scientifically;
Funding local laboratories to identify
pandemic influenza;
Funding sustained efforts at the state and
local level;
Increasing manpower to control sporadic
outbreaks;
Suspending federal laws that limit state's
ability to get antivirals and vaccines to people, close
borders, or otherwise limit state response efforts.
From a public health perspective, the pressure on the
U.S. Department of Homeland Security (DHS) and the Department
of Health and Human would intensify during a pandemic.
Traditional support such as staffing, equipment, and supplies
that DHS provides through FEMA and other federal agencies would
not be available since the entire nation would be affected at
the same time. Public health at the state and local level would
have to respond with existing resources and would not be able
to expect additional resource support from the federal
government.
HHS would have to consider significant waiver of
regulations for health care institutions such as hospitals and
nursing facilities. An altered standard of care must be
considered since facility and medical staff would be extremely
overtaxed. Medical surge temporary facilities would not be able
to meet Medicare standards.
DHS and HHS should consider mechanisms to support the
continued re-supply of pharmaceuticals, medical supplies,
antivirals, and other infrastructure resources for healthcare
facilities. Traditional supply chains will be disrupted.
Increased security will be required for manufacturing,
warehousing, and transportation of these public health and
medical supplies and equipment.
Question 4.: How has pandemic influenza been incorporated into the
Texas Homeland Security Strategic Plan? How do you think your efforts
could be modeled for other states?
Response: The Texas Homeland Security Strategic Plan
states that ``health related emergencies are a homeland
security focus. . .'' This plan addresses the importance of
optimal detection and rapid response as well as human and
animal health surveillance. Texas's Pandemic Influenza Response
Plan is found in Appendix 7 to the Health and Medical Annex H
of the Texas State Emergency Management Plan, which is a
companion document to the Texas Homeland Security Strategic
Plan.
Strengths of Appendix 7 to Annex H which could serve
as models for other states include:
Assignment of supporting roles for 26 distinct
agencies, including two agencies engaged in the state's
preparedness planning efforts for the first time, the
Office of the Secretary of State and the Division of
Economic Development and Tourism within the Office of
the Governor.
Addition of a clear, strong and significant
manpower commitment from the Texas Military Forces to
fully support pandemic influenza response and recovery
operations.
Clear between this plan, which is response to
human influenza, and the Foreign and Emerging Animal
Diseases (FEAD) Plan, which includes response to avian
flu. The Texas Animal Health Commission holds primary
responsibility for the FEAD plan which includes a
supporting role for DSHS.
Addition of educational efforts to agency
stakeholders as a general responsibility for all
agencies.
Question 5.: Please discuss how improving our efficacy against
seasonal flu may reduce risk in the event of a pandemic.
Response:
Seasonal flu is a significant public health problem
that is a major cause of morbidity and mortality annually in
Texas: Approximately 36,000 US deaths are attributed to
seasonal influenza each year; an estimated 3,000-4,000 Texas
deaths annually.
Seasonal flu and pandemic flu have several
characteristics in common:
Given that pandemic flu is likely to emerge as
a combination of seasonal flu and avian flu strains,
vaccination against seasonal flu may be expected to
offer some degree of cross protection against a
pandemic flu strain.
At the very least, vaccination may avoid a co-
infection of seasonal flu on top of a pandemic flu
infection.
Antiviral medications currently being considered for
use against pandemic flu have been developed for use against
seasonal flu. Rather than simply stockpiling these for use
against pandemic flu, their use should integrated into broader
treatment/prophylaxis standards of practice within the health
provider community; thereby:-
Reducing impact of seasonal influenza on
citizens;
Recruiting private providers into the overall
response effort;
Incorporating retail pharmacies into antiviral
distribution pipelines, perhaps setting up a ``vendor
managed inventory'' type of stockpile distribution
within the network of retail pharmacies;
Widespread seasonal influenza vaccination of citizens
should be a part of any seasonal influenza / pandemic flu
response plan. Widespread seasonal flu vaccination needs to be
incorporated into standards of practice so that private
providers and pharmacies are reimbursed for costs of covering
their patients. Seasonal flu vaccination is still consistently
underutilized and current vaccine production is not sufficient
for national and state needs. Increased doses of seasonal
vaccine will not be produced by manufacturers until demand for
current production levels is exceeded. Not only will this
provide greater seasonal flu protection for the population each
year, but also increase vaccine production capacity in case
pandemic flu hits this state and nation.
Seasonal flu vaccine is expected to provide at
least some partial protection against pandemic flu, in
addition to reducing the impact of pandemic infection
by minimizing risk for seasonal/pandemic flu CO-
infections. The last two pandemic flu pandemics have
been a result of a resortment process between a novel
avian strain (such H5/N1) as combined with a
circulating seasonal strain. At least part of the
emerging, resorted pandemic strain will have seasonal
components for which seasonal vaccination will provide
at least partial protection.
Public health should not be expected to carry the full
responsibility for addressing pandemic flu response efforts. A
large number of Texans have health care providers and
insurance. This existing framework of care should be better
utilized in statewide management of seasonal influenza, as well
as continuing to serve as primary care and prevention platforms
for dealing with pandemic flu. Treatment and prevention of
seasonal flu should be incorporated into standards of practice.
This will position healthcare providers and the public to deal
more effectively with a pandemic.
Concerns about development of antiviral resistance
through routine use of antivirals may be offset by the
following:
The pandemic strain that emerges will likely
have a different sensitivity/resistance pattern than
the circulating seasonal strain.
Manufacturers will be encouraged to have new
antivirals in the development pipeline.
Closer surveillance of resistance patterns may
document that use of less costly antivirals, such as
the M2 agent amantadine, alone or in combination with
other medications.
Strategic surveillance with rapid testing for
seasonal/pandemic flu should be in place so that identification
of introduction of seasonal/pandemic flu into Texas occurs at
the earliest possible moment. Models of disease spread and
epidemiologic experience with spread of infection document that
early intervention (control and prevention through targeted use
of antivirals and vaccines) will be the major determinant on
reducing the effect of seasonal and pandemic flu on morbidity
and mortality within the population. The ability to rapidly
distinguish between seasonal and pandemic flu strains is of
vital importance in this early detection effort.
The same personal and community precautions that help
prevent spread of seasonal flu , such as cough etiquette (for
example covering the mouth with a sleeve, rather than a hand);
good hand washing / hand sanitation; staying home when ill, and
human resources policies that promote influenza prevention in
the workplace will help prevent spread of a pandemic strain of
influenza. Additional community strategies to mitigate a
pandemic are likely to be more accepted and better followed if
citizens already take personal, school, and workplace
prevention of influenza seriously.
Question 6.: What do you think we can do now to address health
disparities, and prevent pandemic influenza from disproportionately
affecting parts of our population?
Disparities in public health can be seen in both of
the following areas:
Persons 65 and older not receiving seasonal
flu vaccine: 28.6% of non-Hispanic whites, 49.4% of
Hispanics and 54.1% of African-Americans. Minority
seniors are almost twice as likely to not receive
seasonal flu vaccine. (Source: 2006 BRFSS).
Lack of healthcare coverage in adults under
the age of 65: 13.9% of non-Hispanic whites, 30.0% of
African-Americans, and 50.1% of Hispanics. Hispanics
are more than 3 times and African-Americans 2 times as
likely to not have health care coverage. (Source: 2006
BRFSS).
Addressing these disparities related to
influenza prevention could include additional programs
for seasonal immunization with a focus on closing the
disparity gap, As systems are developed to provide
seasonal immunizations, the capacity to deliver
pandemic immunizations would increase.
Department of Homeland Security has provided
Texas with some funding to exercise hurricane
evacuation and sheltering for the last 3 years. Texas
has studied special needs evacuees, including those
along the border area, in a situation without
utilities. Through the Governor's Division of Emergency
Management and the National Emergency Response and
Rescue Training Center, Texas has worked to identify
and quantify those individuals who will need special
evacuation assistance, special medical assistance. More
effort will need to be made through planning and
exercising to continue to discover additional
requirements needed for extended sheltering and
staffing.
It is unlikely that enough measures can be put
into place to prevent pandemic influenza from
disproportionately affecting parts of the population.
Health care workers will be disproportionately exposed
early on with relatively little warning. Residents in
some areas along the international border will be less
likely to have access to health departments for
information and aid. They may be disproportionately
exposed by immigration. Reaching rural and remote areas
with screening and surveillance will continue to be a
challenge.
Question 7. According to the Implementation Plan for the National
Strategy for Pandemic Influenza, ``The Federal Government shall, and
State, local, and tribal governments should, define and test actions
and priorities required prepare for and respond to a pandemic, within 6
months'' of when the Plan was released--so the deadline would have been
October 2006. What are challenges here? Are you waiting for the Federal
government to provide you with guidance and resources?
Response: Traditionally, Texas has not waited for federal
guidance to define and test actions and priorities. Texas has had a
Pandemic Influenza Plan at the Department of State Health Services
since 2004. It was updated and posted in October 2005. It has since
been renamed the Pandemic Influenza Plan Operating Guidelines (PIPOG).
Revisions to the plan have been made to reflect changes in science,
federal guidance and available resources and as additional pieces of
the plans are developed and tested. DSHS will post revised planning
guidelines by the end of 2007. Local health departments have developed
plans specific to their jurisdictions. State and local plans are
routinely exercised and modified based on after action reports.
Some of the challenges include:
Aligning Texas plans developed prior to
receiving federal guidelines takes time.
With several federal plans and guidelines
coming from different agencies, including Homeland
Security, Health and Human Services, and Centers for
Disease Control and Prevention, determining which
federal guidelines take priority can be a challenge.
Consequently, it is preferable that:
A clear line of leadership to the states is
established.
One set of guidelines which represents the
collective guidance of all involved federal agencies be
developed.
Question 8.: According to the Implementation Plan for the National
Strategy for Pandemic Influenza, ``State, local, and tribal law
enforcement agencies should coordinate with appropriate medical
facilities and countermeasure distribution centers in their
jurisdictions to coordinate security matters, within 6 months'' of when
the Plan was released--so the deadline would have been October 2006. To
your knowledge, has any of this coordination taken place? If so, how,
and if not, how would you recommend this happen?
Response: Coordination between law enforcement agencies
and local health departments is a key element in countermeasure
distribution planning of medication from the National Stockpile. This
coordination has happened with varying of success in local
jurisdictions in Texas and nationwide. This coordination did not appear
to increase substantially as a result of release of this plan. The
importance of this coordination and expected results should be
communicated and emphasized through law enforcement channels to be
effective. This might be done through professional associations as well
as licensing bodies.
Question 9.: What roles do associations play in assisting their
constituents with emergency and pandemic preparedness?
Response: Some associations have an advisory role in
developing plans and operational guidelines for pandemic
preparedness and response. For example, the Texas Medical
Association currently has a representative on the Preparedness
Coordinating Council, which provides oversight for all
preparedness activities. There are also organizations that have
been identified in Annex H: Health and Medical to the State
Emergency Plan as having a responsibility in any statewide
public health disaster response. Other public health and
medical associations play a key role in helping Texas be better
prepared. These organizations are partners with DSHS in
increasing the ability for a timely preparedness response to a
or natural disaster and include the Texas Hospital Association,
the Texas Nurses Association, and the Texas Association of
Local Health Officials.
Question 10. The Government Accountability Office (GAO) says in its
report that State, Territorial, Tribal, Local, and other stakeholders
need to be involved in providing input to the National Strategy for
Pandemic Influenza and its implementation Plan, especially as the
National Strategy evolves. If you were at the White House, how would
you ensure this happens?
Response: States vary in their response planning to
pandemic influenza. There are differences in interpretation of
federal guidelines. State and federal planning are not
synchronized, with the states often planning in advance of the
release of federal guidelines. In addition, states do not
always coordinate with each other, in part due to substantial
differences in governmental structure, law, and demographics.
It would be helpful to include state stakeholders at the
beginning of planning processes rather than at the middle or
end. The best way to achieve that is to provide multiple
vehicles for stakeholders to participate in the process.
Question 11.: As you all know, public health has been identified as
one of the critical infrastructures of our Nation.
a. Have you been included in the planning undertaken by the
Department of Homeland Security to protect the public health
infrastructure?
Response: Although DSHS has not been directly involved
in the planning undertaken by the of Homeland Security (DHS),
DSHS works collaboratively with the Texas Office of Homeland
Security and with the Texas Governor's Division of Emergency
Management. DSHS provided input on the Texas Homeland Security
Strategic Plan 2005--2010.
b. From what you know about this work, how does it affect you
in your and local positions?
Response:
Two documents, the National Strategy for Pandemic
Influenza (November 2005) and the National Strategy for
Pandemic Influenza implementation Strategy (May 2006), provided
Texas with a general framework for the state response as well
as roles and responsibilities for federal agencies. These
documents were used to validate the Texas plan that had already
been developed and to additional elements to be included.
DHS will be responsible for coordination of the
overall federal response during an influenza pandemic, while
the DHS Office of Health Affairs will be leading coordination
of efforts that affect state and local policies. This will
include implementation of policies that facilitate compliance
with recommended social distancing measures, and entry and exit
screening for influenza at the borders as they ensure domestic
security. Texas has 1,240 miles of international border with
many bridges for vehicle and foot traffic to and from Mexico.
Many border counties in Texas do not have local health
departments. Therefore, surveillance at the points of entry
will be critical to Texas during an influenza pandemic. Other
initiatives by DHS that affect Texas include the publication of
the Pandemic Influenza Preparedness Response and Recovery Guide
for Critical Infrastructure and Key Resources (The Guide).
Texas has used the Guide for a State-level Pandemic Influenza
Exercise. Texas has also participated in the Determined Accord
Pan Flu exercise developed by DHS and FEMA.
c. What more do you think needs to be done in this regard,
especially in advance of an influenza pandemic?
DSHS would like to have greater interaction with
representatives of federal agencies or the DHS Regional (PFOs) planners
during preparedness exercises. All plans have elements that may be
subject to ``interpretation,'' and by having federal representatives
present at state-level exercises, some of the ambiguities can be
resolved more quickly.
Question 12.: How do current federal regulations influence your
efforts to stockpile antiviral medications?
Response:
Lack of ability to rotate antiviral stock, to
implement shelf-life extension program, and limitations on
approved uses affected decision-making by the Texas Legislature
when deciding on how many state resources could be allocated
for purchasing antiviral medications for a state stockpile.
Supplies provided from federal contracts are
restricted to use during pandemic influenza. However, current
federal guidelines and packaged labeling do not allow for
rotation of antiviral purchased using the federal contract.
This creates the potential for waste.
Federal policy discontinues the Shelf-life Extension
Program for antiviral drugs once they are delivered to the
states. There is no clear guidance on how long antivirals from
the Strategic National Stockpile (SNS) that have expired dates
will be viable in state stockpiles that cannot qualify for a
Shelf-life Extension Program.
Question 13.: What do you see as a practical solution that
would reduce the investment risk of procuring antiviral
medications while ensuring adequate supplies of these
medications are available in the event of a pandemic?
Response:
Remove the ``For Government Use Only'' labeling on
antiviral packaging to facilitate and allow rotation of stock.
Similar to smallpox vaccine and medications in the
SNS, hold samples from each lot distributed to states for
analysis in a Shelf-life Extension Program, thereby allowing
antiviral in state possession to remain usable after expiration
date.
Negotiate extension of current federally subsidized
contract or a new reduced price to allow more community
critical entities to purchase antiviral at a reduced cost.
Assist with long-term storage rental or adding
environmental controls to state owned warehousing and security
of storage facilities.
Question 14.: What ability do local hospitals in your states have
to accommodate a surge that would be associated with a pandemic?
Response:
Texas hospitals have developed plans to augment
staffing during a pandemic. These include developing databases
of available personnel, developing callback lists, and working
with state medical and nursing organizations to identify and
recruit individuals who are available during a pandemic.
In Texas, 65.9 percent of hospitals reported having a
database of credentialed clinicians while 52.8 percent reported
having a database of other health professionals to contact
during a pandemic.
However, there is concern about being able to meet staffing
demands over the long term. The ability to provide staffing
will be a limiting factor in being able to meet surge demands
during a pandemic.
Currently, availability of resources and equipment to
support a surge capacity event varies throughout Texas.
Hospitals typically keep 72 hours of inventory in stock. To
support resource availability, work group participants report
that some hospitals and Regional Advisory Councils are creating
or contracting with distributors to create equipment and supply
caches. Similarly, a number of hospitals have pre-purchase
contracts in place to deliver specified supplies within 72
hours of a disaster in the event communication systems are
disrupted.
Question 15.: What type of procedures are in place to increase
capacity should a pandemic occur?
Response:
Most Texas hospitals have the ability to increase bed
capacity and supporting physical infrastructure during a
pandemic. The majority (59.7 percent) have a bed expansion plan
in place and local health departments, city and county
governments, and other entities have created plans and
processes to open medical shelters if needed. Alternative plans
and procedures for increasing physical infrastructure capacity
have been developed discharging patients to make room for
disaster victims).
During Hurricanes Katrina and Rita, human resources
were available to provide health and medical care in a mass
care environment. Physicians, nurses, allied health
professionals, mental health professionals, and others
volunteered to provide care.
DSHS is implementing the Texas Disaster Volunteer
Registry, the state's version of the federally-mandated
Emergency Systems for Advance Registration of Volunteer Health
Professionals (ESAR-VHP), which should be operational this
winter. The Registry is being built in collaboration with the
state's key medical licensing and regulatory boards and
supporting professional organizations, such as the Texas Board
of Medical Examiners, the Texas Medical Association and the
Texas Osteopathic Medical Association. The Registry will
provide: (1) pre-registration of medical/healthcare
professional volunteers, as well as supportive lay volunteers;
(2) verification of professional and (3) credentialing of
professionals--all in any effort to enhance rapid medical
response to disasters or public health emergencies.
During Hurricanes Katrina and Rita, evidence indicates
that Texas was able to obtain medical supplies, medications,
and durable medical equipment to support patient care.
The following DoD and VA hospitals are included in and
participate regionally in the Texas medical surge efforts:
Amarillo VA Health Care System
Veterans Affairs Medical Center
Veterans Affairs Medical Center-Bonham
U S Veterans Hospital
Central Texas VA Health Care System
Central Texas Veterans Healthcare System--Waco Campus
Audie L. Murphy Memorial Veterans Hospital
Kerrville VA Medical Center
Michael E. DeBakey VA Medical Center
William Beaumont Army Medical Center
Carl R. Army Medical Center
Brooke Army Medical Center
Questions from the Honorable James Langevin, Chairman of the
Subcommittee on Emerging Threats, Cybersecurity, and Science and
Technology
Response from Peter A. Shult, Phd
Question 1.: Do the activities and responsibilities of public
health laboratories differ when dealing with seasonal influenza versus
the more virulent strain expected for pandemic influenza?
Response 1.: The basic diagnostic, networking and reporting
activities and responsibilities of the public health laboratory (PHL),
as outlined in my testimony document (pages 1--4, Role of the pubic
health laboratory) , are fundamentally the same in response to either
seasonal or pandemic influenza. In the earliest stages of a pandemic we
would be trying to detect and identify the novel influenza subtype and
differentiate it from seasonal influenza strains and other respiratory
pathogens that might be circulating using diagnostic methodologies we
currently employ. Results would be immediately shared with our state
and local health departments and with the Centers for Disease Control
and Prevention (CDC). Furthermore, unusual viral isolates and patient
specimens from which they came would be immediately forwarded to the
CDC for further characterization as is our current protocol. Finally,
we would be interacting with other virus laboratories and rapid
influenza testing sites within our states to monitor their results and
acquire unusual isolates or specimens that they might encounter for
further characterization and expedited delivery to CDC as necessary,
similar in the way that we do now. The biggest difference and challenge
for the PHL in response to a pandemic would be carrying out these
activities during likely periods of reduced staffing (due to personal
or family illness, etc)and significant supply interruptions. This
points out the critical need for PHLs and all response agencies to
develop and exercise Continuity of Operation Plans.
Question 2.: What additional resources do public health
laboratories throughout the Nation--including the territories--need to
be able to better address naturally-occurring and intentionally-
distributed disease agents that threaten our country?
Response 2.: Largely as a result of Public Health Emergency
Preparedness funding from the CDC over the last five or so years, PHLs
have been able to build significant, state-of-the-art molecular-based
diagnostic testing capability and capacity for the rapid and accurate
identification of priority agents of bioterrorism and other significant
public health threats. In addition, PHLs have been able to develop
strong relationships and working networks with clinical laboratories
within their states in order to prepare these laboratories to safely,
effectively and cooperatively respond in the event of a public health
emergency. The cost of these activities in terms of needed staffing,
training, diagnostic equipment and reagents, laboratory security
systems, specimen courier systems, emergency communications and
electronic data sharing systems, etc. has been great. However, the
value to public health of this enhanced laboratory response capability
and capacity is undeniable as evidenced by the effective responses, in
recent years, to threats such as SARS, monkeypox, pertussis and several
nationwide foodborne outbreaks, to name but a few. Consistent and
sustained funding of PHLs will now be critical to maintain the PHL
needs already addressed (listed above and in the testimony document)
not to mention provide for newer and likely more expensive diagnostic
and information and data sharing technologies that will be needed for
even more effective response to public health threats in the future.
Question 3.: What sorts of cautions should laboratorians take into
consideration regarding the use of rapid diagnostic tests for detecting
Influenza A viruses?
Question 3.: There are about 15 different hand-held rapid tests for
influenza on the market today. A number of these are simple enough that
they are permitted to be performed in the point-of-care setting without
laboratory expertise or credentialing. Despite their simplicity, rapid
results and relatively low price, these tests have significant
limitations:
In general, the diagnostic sensitivity (ability to
detect true positives) of these tests is limited (on average,
70--75% according to the CDC) which means patients with
influenza may be misdiagnosed as not having influenza. In some
cases this is due to inherent limitations of the test itself or
to the type of specimen the test calls for (e.g. throat swab,
which is usually not the optimum specimen for influenza, but is
recommended for its ease of collection). Furthermore, it is not
certain which, if any of these tests will work for detection of
a novel, potentially pandemic influenza strain. The result is a
patient that might otherwise be treated for influenza may not
be.
A limitation of any diagnostic test including these rapid
flu tests is when they are performed during periods of low influenza
prevalence (early during a typical flu season or during the earliest
stages after the emergence of a novel influenza strain), false positive
results often occur. This would be particularly worrisome early on
during a pandemic period when false positive results may result in
premature triggering of mitigation strategies, unnecessary usage of
antivirals and unnecessary concern or panic.
Both of these limitations can be overcome by performing and
interpreting these tests in the context of available clinical
information indicative of influenza and surveillance information that
confirms that influenza is circulating in the community. Also, rapid
test sites should be strongly encouraged to confirm suspect (i.e. early
or off-season).rapid results with more accurate laboratory testing,
which is available at a PHL or larger clinical lab. The PHL should take
the lead in identifying and training rapid test sites in proper rapid
test usage and interpretation and provide up-to-date influenza
surveillance information for appropriate epidemiological context for
the test results.
Another concern is widespread use of rapid tests will
interrupt influenza surveillance since these specimens will not
come to the PHL for testing. This limitation can be overcome
(as demonstrated in Wisconsin and other states) by working with
and encouraging rapid tests sites to share both specimens for
confirmatory testing and their test results data, with minimal
inconvenience or financial impact to them.
Perhaps the biggest concern with widespread usage of
these rapid tests is maintaining appropriate biosafety. This is
of particular concern for non-laboratorian users of these tests
in non-traditional, non-laboratory, point-of-care settings
(physician offices, nursing homes, pharmacies, etc) where
appropriate facilities, safety devices and personal protective
equipment (PPE) may not be available or used. While simple to
perform, these tests have steps that can generate infectious
aerosols that could infect the user and those in the testing
vicinity. These users need basic biosafety training, which can
(should ) be provided by knowledgeable PHL or other clinical
laboratorians.
Question 4.: How have the public health laboratories worked with
the Department of Homeland Security to address issues such as
bioterrorism, and naturally occurring infectious disease agents such as
pandemic influenza? What role has the Integrated Consortium of
Laboratory Networks played so far in this regard?
Response 4.: It is my experience in Wisconsin and the opinion of
other PHLs that we have had only very limited or indirect interaction
with the Department of Homeland Security (DHS). At the level of our PHL
association, the Association of Public Health Laboratories (APHL),
significant interactions have occurred including:
Through our national association, APHL, we have
established working relationships with Dr. Randy Long and the
Integrated Consortium of Laboratory Networks (ICLN). We now
have public health laboratorians participating on various
subgroups of the ICLN. These subgroups are working on issues
such as proficiency testing, accreditation, quality control,
methods collection, training, radiological testing capacity.
APHL has also worked with DHS and DoD on the
development of the All-Hazards Receipt Facilities and screening
protocols for PHLs for processing unknown environmental
samples.
APHL is also participating in the DHS lead and AOAC
facilitated process to evaluate PCR assays for use in
autonomous detection systems. APHL strongly opposes the use of
biological and chemical agent detection kits and devices for
field testing in the absence of performance standardization,
field validation and certified individuals trained in the
application of these kits and devices.
Public health laboratory preparedness and response efforts have
been largely (solely?) directed by the CDC at the federal level and by
our state health departments and emergency management agencies. The
latter, in Wisconsin, has had more direct interaction with DHS.
However, PHLs play an integral role in state emergency response
planning and exercising of these plans consistent with federal response
plans (Pandemic influenza, NRP/NIMS, etc.). As for the Integrated
Consortium of Laboratory Networks (ICLN), I think I speak for many PHLs
in saying we recognize what the ICLN is and what its basic goals are
(this has been presented at a number of professional meetings attended
by PHL directors and laboratorians), but we have not been directly
affected by this initiative or consulted during its development.
However, PHLs have developed (or are in the process of doing so) close
working relationships with state and federal agency laboratories within
their states responsible for food, animal and water testing during a
public health or environmental emergency. Each of these labs (at least
in Wisconsin) is part of their own national network in much the same
way that the PHL is part of the LRN. For example, our state veterinary
diagnostic lab belongs to the National Animal Health Laboratory Network
(NAHLN) and our state agriculture/food lab belongs to the Food
Emergency response Network (FERN). Our efforts in planning,
communication and collaborative response to an emergency with these
other laboratories, at this point, has been at the state level with
little direct coordination at the federal level apparent to us.
Question 5.: In your testimony, you stated that there is a ``. .
.critical need for accurate, very rapid, highly reliable diagnostic
testing to make best use of the stockpiles. . . Please provide more
information regarding this critical need. How much more rapid and
reliable do you believe diagnostic testing should be, and how would
this testing make best use of the stockpiles?
Response 5.: Antiviral stockpiles are a major focus of state and
national pandemic preparedness and response efforts. The use of
antivirals for prophylaxis and treatment will be a critical adjunct to
other community mitigation measures particularly during the early
stages and perhaps throughout the first wave of a pandemic in the
absence of a vaccine. It is possible if not likely that supplies of
antivirals may be limited in a given location. Even if there are
sufficient supplies, their mobilization and use will need to be
carefully considered and coordinated. The trigger for any pandemic
response, including use of the antivirals will require laboratory
confirmation that a novel influenza subtype has emerged and is being
transmitted among the population. Most state PHLs now have this
capability since they have been provided funding from the CDC for
resources (staff, diagnostic equipment and reagents, etc)to provide
state-of the art, rapid (2-4 hours from specimen receipt), highly
sensitive and specific molecular-based diagnostic testing for seasonal
and potentially pandemic strains of influenza. These labs also have
excellent diagnostic methods for a large number of other respiratory
pathogens that might need to be ruled out. Thus, if these capabilities
can be maintained and even better tests brought online in the future
with adequate funding, a sensitive trigger for pandemic response is
available. However, as the outbreak or pandemic progresses and once
antiviral stockpiles are distributed to the point-of-care, diagnostic
testing and subsequent treatment decisions will be at the level of the
clinician. At this point, it would be advantageous to have highly
accurate point-of-care testing available to help ensure appropriate use
and prevent over- and misuse of the antivirals. As I have pointed out
in question 3., this currently isn't the case. Clearly more development
in this area is needed. Even with improved point-of-care diagnostics,
up to date regional laboratory-based surveillance data, necessary
confirmatory testing and antiviral susceptibility testing needs to be
made available. This should be among the critical roles for the PHL.
Question 6.: A number of testing protocols have been provided to
members of the Laboratory Response Network for Bioterrorism, to test
for various biological agents. However, there is concern about those
situations in which particular agents are not identified or suspected
ahead of testing. Further, in the case of pandemic influenza--
especially if the virus causing the pandemic does not happen to be
H5N1--there will certainly not be any accompanying notes describing the
makeup of the virus. How are specimens analyzed before any disease
identification has been made (in other words, how do the labs deal with
specimens of unknown composition)?
Response 6.: Biosafety is a paramount concern in any clinical
laboratory and especially in the PHL where we frequently are involved
in unknown and unusual outbreak situations. In fact, it is the norm
that we do not know what pathogen(s) we might encounter. In addition,
we often receive and immediately test specimens from patients from whom
we have no clinical or relevant epidemiologic information. We always
operate from the premise that the specimen contains the worse possible
agent. . .always! This is the same philosophy that is the underpinning
for ``Universal Precautions'', familiar to all care givers and
laboratorians in safely handling blood and body fluids that might
contain bloodborne pathogens. Consequently, all patient specimens or
unknown isolates received for further characterization should be
initially handled and processed in a biological safety cabinet (BSC) in
(at a minimum) a Biosafety Level 2 (BSL-2) laboratory using practices
and PPE appropriate to that biosafety level. . While impeccable sterile
technique is the mainstay of safe handling of the specimen/isolate, the
BSC, when used properly, provides a high level of protection (from
routine pathogens as well as agents of greater public health concern
such as primary agents of bioterrorism, influenza, SARS virus,etc.) for
the laboratorian doing the testing and those around him. In the event
that we might suspect a patient or environmental specimen, test
material referred to us or generated during the testing within our lab
contains a pathogen requiring a higher level of biosafety, work would
be carried out in our BSL-3, or ``containment'' laboratory, which
provides a much higher level of containment and requires more
specialized equipment and a higher level of PPE to protect the facility
and better protect the testing staff. Our biosafety protocols are
carefully written and rigorously followed and are consistent with
guidelines set forth by the CDC.
While I am very confident of the effectiveness of these protocols
and of the biosafety expertise within the PHL, I am much less confident
when it come to clinical diagnostic labs, particularly those in smaller
hospital and clinics, and point-of-care testing sites (mentioned
above). These hospital-based labs will likely be the frontline
responders in an infectious disease emergency, whether naturally
occurring or intentional. Here is where our concern should really lie
and where intensive training efforts should be directed. Indeed, we in
Wisconsin and other states have begun these efforts.
Question 7.: How are the public health laboratories working with
the CDC to ``. . .monitor the emergency of antiviral resistance that we
have already seen with one whole class of antivirals''? To which class
are you referring?
Response 7.: During the 2005-06 influenza season, the CDC announced
and published evidence that showed greater the 90% of the circulating
seasonal influenza type A viruses tested were resistant to one of the
two classes of antivirals available for treatment or prophylaxis of
influenza, the adamantanes (amantadine and rimantadine). Results last
season were similar. Consequently, use of the adamantanes is no longer
recommended. Immediately after these results were reported (in winter
2006), the Wisconsin State laboratory of Hygiene (WSLH) was contacted
by the CDC and asked to bring online antiviral susceptibility testing
for the adamantanes to provide surge capacity for the CDC to continue
to monitor the level of resistance to the antiviral of seasonal
influenza and in case a novel subtype emerged. At least 2 other state
PHLs have followed suit. Last year these PHLs contributed to the
surveillance efforts and stand ready to continue these efforts this
year and respond should a novel subtype emerge. While some funding was
initially secured (at least in Wisconsin) from CDC to purchase
expensive equipment and reagents for this testing, actual PHL antiviral
resistance surveillance testing largely has been self-funded. The CDC
has also begun surveillance for resistance to the only remaining class
of influenza antiviral, the neuraminidase inhibitors
(Relenza' and Tamiflu'). Discussions with CDC are
currently underway for some state PHLs to help with this surveillance
as well; however, currently only CDC has this capability. The long term
goal would be to have the CDC, supported by select PHLs to maintain
ongoing surveillance for antiviral resistance among circulating
seasonal influenza strains and have this testing available should a
novel, possibly pandemic strain of influenza virus emerge. Given the
previously mentioned reliance on antiviral for pandemic response, this
surveillance will be critical. However, these efforts need to be
supported with stable funding.
Question 8.: The Implementation Plan for the National Strategy for
Pandemic Influenza provided this task, ``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''--which would have been July
2006. What challenges do you see with executing this task? Why has this
task has been so difficult to address throughout the country?
Response 8.: In my firsthand experience in Wisconsin and knowledge
of some other states, Public Health Emergency Preparedness and other
funding from CDC has been used to fund critical specimen transportation
to PHLs . Funded activities include development of emergency response
and specimen shipping guidelines and protocols, maintaining statewide
repositories of critical specimen collection supplies and shipping kits
for use by clinical labs and local health departments, training on
specimen shipping procedures and regulation, contracting with private
couriers (in fact more than one for redundancy)or maintaining the
laboratory's own courier, among others. While these activities were
originally carried out for response to bioterrorism, they have ``all
hazards'', including pandemic influenza, applicability. At least in
Wisconsin (and I know other states as well), our specimen transport
systems and protocols have been frequently and successfully utilized
and practiced during a number of recent outbreaks (some quite large) we
have been involved in and exercises we carry out with our clinical
laboratory partners. This capacity now exists. The challenge, as I see
it, will be maintaining this capacity during a pandemic when courier
services will be disrupted due to illness or fear of carrying certain
specimens (a concern we have had expressed to us by the larger
commercial couriers vs. the small private company and HMO or large
clinical lab couriers we utilize), specimen collection supplies and
shippers may be in short supply, etc. We are currently considering
these issues with partners in response and examining ways to provide
redundancies for transport, augment stockpiles of critical supplies,
prioritize critical testing needs that absolutely require specimens be
shipped to my lab and at the same time cover costs. An issue on the
national level that has not yet been addressed to my knowledge is how
will the state PHL get critical specimens to the CDC, our reference
laboratory, given the consequences of a pandemic described above.
Questions 9.: According to the Implementation Plan for the National
Strategy for Pandemic Influenza, ``The Federal Government shall, and
State, local, and tribal governments should, define and test actions
and priorities required to prepare for and respond to a pandemic,
within 6 months'' of when the Plan was released--so the deadline would
have been October 2006. What are the challenges here? Are you waiting
for the Federal government to provide you with guidance and resources?
Response 9.: Given the critical role of the PHL in preparedness
planning and response to pandemic influenza, working in close
collaboration with other national, state and local public health and
emergency response partners, their priorities need to be addressed (and
funded) and actions defined and exercised. To date, my laboratory has
only engaged in relatively limited tabletop exercises with clinical
laboratory partners and with local and state public health agencies
with minimal involvement with other traditional emergency response
partners. Despite their limited scope, these exercises have been
extremely valuable in defining the likely obstacles to an effective
laboratory and public health response and how these might be overcome
and providing valuable and actionable lessons learned. In my opinion
(and that of other state PHL colleagues with broader experience with
more complex exercises) conducting broader community-based exercises is
extraordinarily complex to plan and carryout, expensive and disruptive
to day-to-day work activities. This is not surprising given the
immensity and diversity of a pandemic's likely impact and the response
needed. I am in favor of our laboratory's approach in testing parts of
the plan (both national and state plans) with limited response
partners; however, I acknowledge that larger exercises with more
diverse participants to test a specific aspect of the plan (e.g.
conducting vaccine clinics, antiviral stockpile mobilization, etc)
likely will be needed.
Questions 10.: According to the Implementation Plan for the
National Strategy for Pandemic Influenza, ``State, local, and tribal
law enforcement agencies should coordinate with appropriate medical
facilities and countermeasure distribution centers in their
jurisdictions to coordinate security matters, within 6 months'' of when
the Plan was released--so the deadline would have been October 2006. To
your knowledge, has any of this coordination taken place? If so, how,
and if not, how would you recommend this happen?
Response 10.: This question is really beyond the scope of the
laboratory and definitely beyond my experience.
Questions 11.: What roles do associations play in assisting their
constituents with emergency and pandemic preparedness?
Response 11.: Speaking only about laboratory-related professional
associations [including the APHL, American Society for Microbiology
(ASM), College of American Pathologists (CAP), American Clinical
Laboratory Association (ACLA), to name a few] it has been my experience
that these associations have been very active and effective in
assisting their constituents with emergency and pandemic preparedness.
Each of these associations' website is loaded with planning documents,
testing recommendations and protocols and links to resources, many of
which have been collaboratively developed. Moreover, these associations
provide their input to national planning efforts. I have participated
in and facilitated a number of very effective working groups among
these associations, largely coordinated by the CDC, that have tackled
issues related to emergency (including pandemic influenza) preparedness
and response including:
Roles for the large national clinical labs in pandemic
response
Development of testing guidelines
Impact of new generation point-of-care tests on
laboratory diagnosis
Biosafety issues
The same can be said about numerous public health and clinical
specialty associations Engaging the leadership of these associations in
planning efforts and using these associations to reach their thousands
of constituents to share information is a highly efficient and
effective element of preparedness and response planning.
Question 12.: The Government Accountability Office (GAO) says in
its report that State, Territorial, Tribal, Local, and other
stakeholders need to be involved in providing input to the National
Strategy for Pandemic Influenza and its Implementation Plan, especially
as the National Strategy evolves. If you were at the White House, how
would you ensure this happens?
Response 12.: As an extension of my answer to question 11, relevant
federal agencies should be responsible and held accountable for
implementation of the National Strategy and for engaging relevant
partners (much as CDC has done with laboratories and state and local
public health agencies). Key partners should include professional
associations that can ensure content experts are identified (with
significant experience in laboratory science and public health, for
instance) and state and local input is solicited in the development and
implementation of policies and plans. It also needs to be recognized
that emergency response in the final analysis will be carried out
primarily at the local and state level with support needed from federal
resources.
Questions 13.: As you all know, public health has been identified
as one of the critical infrastructures of our Nation. Have you been
included in the planning undertaken by the Department of Homeland
Security to protect the public health infrastructure? From what you
know about this work, how does it affect you in your state and local
positions? What more do you think needs to be done in this regard,
especially in advance of an influenza pandemic?
Response 13.: Neither the WSLH nor any other PHL that I am aware of
has been included in planning undertaken by DHS to protect PH
infrastructure. It is important, however, that DHS and other federal
agencies recognize the importance of the PHL and the clinical
laboratory networks we oversee within our states for response to
pandemic influenza or other public health emergencies. Conversely, we
(PHLs and public health in general) need to fully understand the role,
authority and expectations of DHS in protecting public health
infrastructure, starting with defining public health infrastructure and
what the term ``protect the PH infrastructure'' refers to. I interpret
it to mean strengthen and sustain public health (including the PHL)
capabilities and capacity now so we are prepared to mount an effective
public health response to any emergency such as pandemic influenza. .
.and protect public health capabilities and capacity during the
response. It is obvious to me that the first steps need to be
communication, so that we all can ultimately recognize and understand
each other's roles and expectations, and a commitment to funding this
critical response element.
Responses respectfully submitted on behalf of the Association of
Public Health Laboratories by:
Peter A Shult, PH.d.
Director, Communicable disease Division
and Emergency Laboratory Response
Wisconsin State Laboratory of Hygiene
Questions from the Honorable James Langevin, chairman, Subcommittee on
Emerging Threats, Cybersecurity, and Science
Responses from Bernice Steinhardt
Question 1.: Regarding the Implementation Plan for the National
Strategy for Pandemic Influenza, you state in your report that, ``. .
.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.'' What sort of process do you propose
should be used to rectify this situation now?
Response: In our August 14, 2007, report (Influenza Pandemic:
Further Efforts Are Needed to Ensure Clearer Federal Leadership Roles
and an Effective National Strategy, GAO-07-781), we reported that many
of the performance measures contained in the Implementation Plan
consisted of actions to be completed such as guidance developed and
disseminated. Without a clear linkage to anticipated results these
measures make it difficult to ascertain whether progress is being made
toward achieving the goals and objectives described in the Plan and the
National Strategy for Pandemic Influenza.
In our report, we recommended that the Homeland Security Council
establish a specific process and time frame for updating the Plan. We
further recommended that during this update, the Plan could be improved
by including information in the Plan such as a greater use of outcome-
focused performance measures.
Question 2.: You state in your report that one of the difficulties
with the National Strategy for Pandemic Influenza is that it has not
been made clear how it relates to and interacts with others of our
National Strategies. How have other National Strategies have made this
clear? How would you recommend this occur now with the National
Strategy for Pandemic Influenza?
Response: Over the past several years, GAO has reviewed several
national strategies and we have found that these strategies could have
better described how they were linked to the goals, objectives, and
activities of other related strategies.
As part of our recommendation to the Homeland Security Council to
establish a specific process and time frame for updating the Plan, we
stated that the Council's next update of the Plan should more clearly
describe the linkages between the Plan with other related strategies
and plans.
Question 3.: You state in your report that State, Territorial,
Tribal, Local and other stakeholders need to be involved in providing
input to the National Strategy for Pandemic Influenza and its
Implementation Plan, especially as the National Strategy evolves. How
do you propose this should occur? Who should be responsible for
ensuring stakeholders are not only invited to provide input, but that
their input is indeed incorporated?
Again, in our recommendation to the Homeland Security Council
regarding the need to update the Plan, we stated that the update
process should involve key stakeholders and incorporate lessons learned
from exercises and other sources. Since the Implementation Plan is the
responsibility of the Homeland Security Council, it should be up to the
Council to not only invite stakeholders to provide input to the next
update of the Plan, but to also make sure that the Plan reflects their
input. In addition, the agencies that worked with the Council in
drafting the Plan, such as the Departments of Homeland Security and
Health and Human Services, could hold forums and discussions with their
stakeholders and seek their input during the update process.
Questions from the Committee on Homeland Security
Responses from RADM W. Craig Vanderwagen, MD
Question 1.: The Assistant Secretary for Preparedness and Response
has a unit that deals with exercises. The Office of the Assistant
Secretary for Preparedness and Response has also reached out to the
Department of Homeland Security regarding the use of the Lessons
Learned Information Sharing system. How is HHS using the system? How
are personnel in the Office of the Assistant Secretary of Preparedness
and Response working with those in the Office of Health Affairs, the
National Exercise Program, and other programs at the Department of
Homeland Security, to combine efforts and data?
Response: The Training, Exercise and Lessons Learned Team (TE&LL)
in the Office of the Assistant Secretary for Preparedness and Response
(ASPR), as appropriate, maximally employs the Department of Homeland
Security's (DHS) tools and systems as prescribed in HSPD-8 to manage
HHS training activities, exercises, and lessons learned.
The TE&LL Team represents HHS at the Exercise and Evaluation Sub
Policy Coordinating Committee (PCC) (formerly the Plans, Training and
Exercise PCC of the Homeland Security Council). Within this forum HHS
liaises with DHS and the National Exercise Program, and all other
Departments and agencies. This body meets bi-weekly and offers an
excellent forum for interdepartmental communications.
The TE&LL Team represents HHS on the Executive Steering Committee
of the National Exercise Program (NEP), and collaborates frequently
with DHS on submitting joint exercise proposals (Pandemic Influenza
Exercise Series). HHS also sits on the TOPOFF 4 Executive Steering
Committee, and participates in all Principal Level Exercise and Senior
Official Exercise activities. DHS acts as the executive agent for
managing all of the preceding committees.
HHS participates in all principal National Exercise Schedule (NEXS)
conferences and meetings.
HHS maintains five blanket purchasing agreements (BPAs) with many
of the same vendors that DHS utilizes for managing their HSPD-8
activities. This leads to better synergy and alignment between HHS and
the HSPD-8 tools and activities. With help from contract support, HHS
is actively moving all of its major training, exercise, and lessons
learned paper-based systems to the HSPD-8 electronic based system.
A standing weekly call is held between the Assistant Secretary for
Preparedness and Response and the DHS Office of Health Affairs Acting
Assistant Secretary/Chief Medical Officer to coordinate efforts and
activities.
At HHS' Strategic Readiness Plan (SRP) Roll Out in August 2007,
multiple DHS programs were invited to participate along with their
leadership (Corrective Action Program, National Exercise System
directors). At the SRP Roll Out the Department formally adopted the
HSPD-8 tools into its training, exercise, and lessons learned
management processes.
Some components of HHS have achieved initial integration with DHS's
Lessons Learned Information Sharing (LLIS.gov) system. For example, the
Centers for Disease Control and Prevention (CDC) Coordinating Office
for Terrorism Preparedness and Emergency Response (COTPER), Division of
State and Local Readiness (DSLR) has partnered with LLIS.gov to develop
the CDC DSLR ``Channel'' on LLIS.gov. Channels are secure areas of
LLIS.gov dedicated and customized to the preferences of a specific
community of interest, organization, or jurisdiction. The CDC DSLR has
written into its grant guidance that LLIS.gov is the official
repository of State and local jurisdictions' exercise schedules. To
date, CDC DSLR grantees have uploaded more than 80 exercise schedules
to the LLIS.gov Channel. Additionally, the Channel is used as a shared
workspace and information sharing forum for federal, State, and local
health stakeholders.
Question 2.: Please provide us with information regarding the
changes in ESF-8 from the National Response Plan to the National
Response Framework. What impact will these changes--and any others in
other parts of the National Response Framework--have on the pandemic
influenza plans you already have in place?
Response: The text for the ESF#8 Annex currently contained in the
National Response Framework is the same language HHS submitted to DHS
for the National Response Plan and supports the HHS/ESF#8 effort to
prevent, protect, respond, and recover from all domestic response
activities. There is no impact on pandemic influenza planning. The text
was updated to reflect recent legislative changes impacting ESF#8. This
included the following:
In the event of a public health emergency the
Secretary of HHS shall assume command and control, when
appropriate, of Federal emergency public health and medical
response assets that have appropriate MOUs in place, except for
members of the Armed Forces, who remain under the authority and
control of the Secretary of Defense.
The Secretary of HHS, through the Office of the
Assistant Secretary for Preparedness and Response (ASPR),
coordinates national ESF#8 preparedness, response, and recovery
actions.
Updated to reflect the transfer of the National
Disaster Medical System (NDMS) from DHS to HHS.
Question 3.: According to the White House, HHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by July 2006. The task is,
``HHS shall improve the speed at which it performs mortality
surveillance through the 122 Cities Mortality Reporting System within 3
months.'' Why has this task not been completed yet?
Response: Since the release of the National Strategy for Pandemic
Influenza Implementation Plan, much has been accomplished to realize
the U.S. Government's pandemic preparedness and response goals of: (1)
stopping, slowing, or otherwise limiting the spread of a pandemic to
the United States; (2) limiting the domestic spread of a pandemic and
mitigating disease, suffering, and death; and (3) sustaining
infrastructure and mitigating impact to the economy and the functioning
of society.
Although we have realized progress in expanding disease
surveillance abroad, critical gaps remain with respect to ``real-time''
disease detection and clinical surveillance in the United States. As
part of its national influenza surveillance effort, the CDC currently
receives weekly mortality reports from 122 cities and metropolitan
areas in the United States. This information helps the CDC track trends
in disease spread, identify severely affected populations, and monitor
the impact of influenza on health. One of the limitations of this
system, however, is an approximately 2-week lag in obtaining data.
BioSense is a national program intended to improve the Nation's
capabilities by conducting nearly real-time clinical disease
surveillance. Of the nearly 6,000 hospitals in the United States, only
700 hospitals are currently engaged in some stage of implementation for
sharing data with the BioSense program.
Question 4.: According to the White House, HHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by October 2006. The task is,
``HHS, in coordination with DHS, DOT, DOS, DOC, and DOJ, shall develop
policy recommendations for aviation, land border, and maritime entry
and exit protocols and/or screening and review the need for domestic
response protocols or screening within 6 months.'' Why has this task
not been completed yet?
Since the release of the National Strategy for Pandemic Influenza
Implementation Plan, much has been accomplished to realize the U.S.
Government's pandemic preparedness and response goals of: (1) stopping,
slowing, or otherwise limiting the spread of a pandemic to the United
States; (2) limiting the domestic spread of a pandemic and mitigating
disease, suffering, and death; and (3) sustaining infrastructure and
mitigating impact to the economy and the functioning of society.
Once an influenza pandemic reaches the United States, the primary
focus is safeguarding the health of Americans. The U.S. Government is
working to enhance the Nation's ability to detect and respond early and
effectively to a pandemic. To better identify the first cases of
pandemic influenza in a community, the U.S. Government has provided
resources to State and local health departments to increase the number
of sentinel providers and improve laboratory detection at public health
laboratories. The U.S. Laboratory Response Network (LRN), which
includes State public health laboratories, is prepared to conduct
initial testing of suspected human infection with H5N1 within 24 hours
of receipt. To ensure that suspected cases can be promptly confirmed
and treated, the Federal Government is working with industry partners
to develop rapid diagnostic tests to quickly discriminate pandemic
influenza from seasonal influenza or other illnesses.
Question 5.: According to the White House, HHS was to have
completed this action item from the Implementation Plan for the
National Strategy for Pandemic Influenza--by January 2007. The task is,
``HHS, in coordination with DHS, DOS, DOD, DOL, VA, and in
collaboration with State, local, and tribal governments and private
sector partners, shall develop plans for the allocation, distribution,
and administration of pre-pandemic vaccine, within 9 months.'' Why has
this task not been completed yet?
Allocation
Medical countermeasures have little utility if they cannot be
delivered quickly to those in need, yet the logistical challenges of
rapidly allocating, distributing, and administering countermeasures to
300 million Americans are substantial. Although we have made
significant investments in distribution capacity since 2002 through the
Strategic National Stockpile, State and local grant programs, and the
Cities Readiness Initiative, much work remains. Guidance and resources
have been provided to State, local, tribal, and territorial governments
to facilitate completion of distribution plans for medical
countermeasure stockpiles. Recipients of pandemic influenza
supplemental funding are required to complete and exercise these plans.
Countermeasure allocation and distribution is important for
preparing our Nation for pandemic influenza and other naturally
occurring infectious diseases, as well as for chemical and nuclear
attacks. In the future we may be faced with the need to prioritize
scarce medical resources during a major disaster. The pandemic efforts
could well serve as a template for allocating and distributing life-
saving countermeasures against other threats. The ongoing guidance
development process for prioritizing and deploying countermeasures
during a pandemic represents our first steps in addressing this complex
ethical and logistical challenge.
One major goal of the U.S. pandemic influenza vaccination program
is to vaccinate all persons in the United States who choose to be
vaccinated. An interdepartmental working group led by HHS developed and
prepared a draft report leading to guidance that analyzed and
established prioritization tables of different functional population
groups and accompanying rationale for the allocation of pre-pandemic
and pandemic influenza vaccines at the onset and during an influenza
pandemic with a CDC severity index of 5. This report is distributed
currently for public comment through Dec. 31, 2007 (See http://
www.aspe.hhs.gov/panflu/vaccinepriorities.shtml). Final guidance is
expected in early 2008.
The draft guidance is firmly rooted in the most up-to-date
scientific information available, and directly considers the values of
our society and the ethical issues involved in planning a phased
approach to pandemic vaccination. Information considered by the working
group included rigorous scientific assessments of pandemics and
pandemic vaccines, national and homeland security issues, essential
community services and the infrastructures and workforces critical to
maintaining them, and the perspectives of state and local public health
and homeland security experts. Historical analysis of the influenza
pandemics of 1918, 1957, and 1968 and their effects provided valuable
insights to this draft guidance. Ethical considerations presented by an
ethicist who served on the working group and by academic ethicists also
were important to the working group process and deliberations.
A formal decision-analysis process also was undertaken that
considered the objectives of a pandemic vaccination program and the
degree to which protecting population groups (defined by their
occupation, age, and health status) contributed to meeting those
objectives. Based on this process, groups that ranked highest were
frontline public health responders, essential health care workers,
emergency medical service providers, and law enforcement personnel.
Among the general population groups, infants and toddlers ranked
highest.
It is recognized that vaccine supply to meet this goal will likely
not be available all at once, but rather, develop at varying rates
depending on both vaccine characteristics (antigen required) and
production capacity. Given that influenza vaccine supply will increase
incrementally as vaccine is produced during a pandemic, allocation
decisions will have to be made. Such decisions should be based on
publicly articulated and discussed program objectives and principles.
The overarching objectives guiding vaccine allocation and use during a
pandemic are to reduce the impact of the pandemic on health and
minimize disruption to society and the economy.
One of the most important findings of the working group analysis,
and the strongest message from the public and stakeholder meetings, was
that there is no single, overriding objective for pandemic vaccination
and no single target group to protect at the exclusion of others.
Rather, there are several important objectives and, thus, vaccine
should be allocated simultaneously to several groups. Each of the
meetings came to the same conclusions about which program objectives
are most important:
Protecting those who are essential to the pandemic
response and provide care for persons who are ill,
Protecting those who maintain essential community
services,