[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]


 
                      DISEASE SURVEILLANCE SYSTEMS

=======================================================================

                                HEARING

                                 of the

          SUBCOMMITTEE ON EMERGENCY PREPAREDNESS AND RESPONSE

                                 of the

                 SELECT COMMITTEE ON HOMELAND SECURITY
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                               __________

                           SEPTEMBER 24, 2003

                               __________

                           Serial No. 108-27

                               __________

    Printed for the use of the Select Committee on Homeland Security


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house

                               __________


                    U.S. GOVERNMENT PRINTING OFFICE
20-168                      WASHINGTON : 2005
_____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512ï¿½091800  
Fax: (202) 512ï¿½092250 Mail: Stop SSOP, Washington, DC 20402ï¿½0900012005


                 SELECT COMMITTEE ON HOMELAND SECURITY

                 CHRISTOPHER COX, California, Chairman

JENNIFER DUNN, Washington            JIM TURNER, Texas, Ranking Member
C.W. BILL YOUNG, Florida             BENNIE G. THOMPSON, Mississippi
DON YOUNG, Alaska                    LORETTA SANCHEZ, California
F. JAMES SENSENBRENNER, JR.,         EDWARD J. MARKEY, Massachusetts
Wisconsin                            NORMAN D. DICKS, Washington
W.J. (BILLY) TAUZIN, Louisiana       BARNEY FRANK, Massachusetts
DAVID DREIER, California             JANE HARMAN, California
DUNCAN HUNTER, California            BENJAMIN L. CARDIN, Maryland
HAROLD ROGERS, Kentucky              LOUISE McINTOSH SLAUGHTER,
SHERWOOD BOEHLERT, New York            New York
LAMAR S. SMITH, Texas                PETER A. DeFAZIO, Oregon
CURT WELDON, Pennsylvania            NITA M. LOWEY, New York
CHRISTOPHER SHAYS, Connecticut       ROBERT E. ANDREWS, New Jersey
PORTER J. GOSS, Florida              ELEANOR HOLMES NORTON,
DAVE CAMP, Michigan                    District of Columbia
LINCOLN DIAZ-BALART, Florida         ZOE LOFGREN, California
BOB GOODLATTE, Virginia              KAREN McCARTHY, Missouri
ERNEST J. ISTOOK, Jr., Oklahoma      SHEILA JACKSON-LEE, Texas
PETER T. KING, New York              BILL PASCRELL, JR., New Jersey
JOHN LINDER, Georgia                 DONNA M. CHRISTENSEN,
JOHN B. SHADEGG, Arizona               U.S. Virgin Islands
MARK E. SOUDER, Indiana              BOB ETHERIDGE, North Carolina
MAC THORNBERRY, Texas                CHARLES GONZALEZ, Texas
JIM GIBBONS, Nevada                  KEN LUCAS, Kentucky
KAY GRANGER, Texas                   JAMES R. LANGEVIN, Rhode Island
PETE SESSIONS, Texas                 KENDRICK B. MEEK, Florida
JOHN E. SWEENEY, New York

                      JOHN GANNON, Chief of Staff

         UTTAM DHILLON, Chief Counsel and Deputy Staff Director

               DAVID H. SCHANZER, Democrat Staff Director

                    MICHAEL S. TWINCHEK, Chief Clerk

                                 ______

          Subcommittee on Emergency Preparedness and Response

                    JOHN SHADEGG, Arizona, Chairman

CURT WELDON, Pennsylvania,           BENNIE G. THOMPSON, Mississippi
W.J. ``BILLY'' TAUZIN, Louisiana     JANE HARMAN, California
CHRISTOPHER SHAYS, Connecticut       BENJAMIN L. CARDIN, Maryland
DAVE CAMP, Michigan                  PETER A. DeFAZIO, Oregon
LINCOLN DIAZ-BALART, Florida         NITA M. LOWEY, New York
PETER KING, New York                 ELEANOR HOLMES NORTON, District of 
MARK SOUDER, Indiana                 Columbia
MAC THORNBERRY, Texas                BILL PASCRELL, JR., New Jersey
JIM GIBBONS, Nevada                  DONNA M. CHRISTENSEN, U.S. Virgin 
KAY GRANGER, Texas                   Islands
PETE SESSIONS, Texas                 BOB ETHERIDGE, North Carolina
CHRISTOPHER COX, California, ex      KEN LUCAS, Kentucky
officio                              JIM TURNER, Texas, ex officio

                                  (ii)
                                CONTENTS

                              ----------                              
                                                                   Page

                               STATEMENTS

The Honorable John B. Shadegg, a Representative in Congress From 
  the State of Arizona, and Chairman, Subcommittee on Emergency 
  Preparedness and Response......................................     1
The Honorable Christopher Cox, a Representative in Congress From 
  the State of California, and Chairman, Select Committee on 
  Homeland Committee
  Oral Statement.................................................     3
  Prepared Statement.............................................     4
The Honorable Bennie G. Thompson, a Representative in Congress 
  From the State of Mississippi, and Ranking Member, Subcommittee 
  on Emergency Preparedness and Response.........................     2
The Honorable Jim Turner, a Representative in Congress From the 
  State of Texas, and Ranking Member, Select Committee on 
  Homeland Security..............................................    69
The Honorable Donna M. Christensen, a Delegate From the U.S. 
  Virgin Islands.................................................    71
The Honorable Jennifer Dunn, a Representative in Congress From 
  the State of Washington........................................    67
The Honorable Jim Gibbons, a Representative in Congress From the 
  State of Nevada, Prepared Statement............................     6
The Honorable Christopher Shays, a Representative in Congress 
  From the State of Connecticut..................................    74

                               WITNESSES

Ms. Janet Heinrich, Director, Public Health Issues, U.S. General 
  Accounting Office
  Oral Statement.................................................    27
  Prepared Statement.............................................    28
Mr. Joseph Henderson, Associate Director for Terrorism 
  Preparedness and Response, Centers for Disease Control
  Oral Statement.................................................     7
  Prepared Statement.............................................    10
Guest: Dr. John Loonsk...........................................    75
Dr. Paul Keim, Cowden Endowed Chair in Microbiology, Northern 
  Arizona University and Director, Pathogen Genomics at T-Gen....    63
Dr. Richard Platt, Chair of the Ambulatory Care and Prevention, 
  Harvard Health Plan
  Oral Statement.................................................    40
  Prepared Statement.............................................    48
Dr. Jonathon Temte, Infectious Disease Specialist, American 
  Academy of Family Physicians
  Oral Statement.................................................    56
  Prepared Statement.............................................    58
Mr. Jeffrey Trent, President of the Translational Genomics 
  Research Institute and Former Director, National Human Genome 
  Research Institute
  Oral Statement.................................................    61
  Prepared Statement.............................................    62

                                APPENDIX
                   Material Submitted for the Record

Prepared Statement of the Honorable Shelley Berkley, a 
  Representative in Congress from the State of Nevada............    83
Questions and Responses from Ms. Janet Heinrich, Director, Health 
  Care, Public Health Issues.....................................    85
Prepared Statement of Mr. Christopher K. Lake, Director, 
  Hospital, Preparedness, Nevada Hospital Association............   122
Questions and Responses from Dr. Richard Platt, Chair of the 
  Ambulatory Care and Prevention, Harvard Health Plan............    86
Questions and Responses from Dr. Jonathan L. Temte...............    87


                          HOW CAN THEY HELP US
                       PREPARE FOR BIOTERRORISM?

                              ----------                              


                     WEDNESDAY, SEPTEMBER 24, 2003

                     U.S. House of Representatives,
                          Subcommittee on Emergency
                         Preparedness and Response,
                     Select Committee on Homeland Security,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 2:54 p.m., in 
Room 2318, Rayburn House Office Building, Hon. John Shadegg 
[chairman of the subcommittee] presiding.
    Present: Representatives Shadegg, Shays, Diaz-Balart, 
Thornberry, Gibbons, Thompson, Norton, Christensen, Etheridge, 
Lucas of Kentucky, Cox, Turner and Dunn.
    Mr. Shadegg. [Presiding.] The committee will come to order. 
I would like to welcome our panel. I apologize for the slight 
delay in starting. As you know, we had a series of votes on the 
floor. I am certain there will be members trickling in over the 
next few minutes.
    Today, we will be examining the role of disease 
surveillance systems in preparing our nation for bioterrorism. 
Clearly, the most preventive action we can take in terms of 
bioterrorism prevention and preparedness is to develop 
countermeasures against them so that even if terrorists strike, 
their intentions would be thwarted because the American public 
would be immune.
    The committee and the House took a critically important 
step by passing Project Bioshield, an effort to stimulate 
investment in bioterror countermeasures. I am pleased that 
funding for that important program was approved as a part of 
the homeland security appropriations conference report passed 
just earlier today.
    While we wait for the innovation of biotech, pharmaceutical 
and medical device companies to develop those countermeasures, 
however, the second most preventive thing we can do is to be 
looking at ways in which to be able to detect a potential 
outbreak through either surveillance systems or monitors so 
that we can take proactive steps to stem its spread. That is 
the focus of our hearing today.
    Whether terrorists choose to spread a pathogen through the 
air, through our food supply or through our water supply, 
although sensors are being developed and tested, we likely 
would not know that such an attack had occurred until many 
citizens showed symptoms of that disease or that sickness. But 
how would we know that these symptoms are more than just an 
outbreak of the flu or a series of colds? How would we know, 
indeed, that patient symptoms were the result of a release of a 
bioterror agent? Would our primary care and emergency 
department physicians, the so-called ``canaries in the coal 
mine,'' be able to decipher the difference? Or would we have to 
wait for additional investigation by health plans and insurers 
to take place before we were able to recognize a pattern of 
sickness as in fact a bioterror attack?
    Today, our expert panel will help us answer these questions 
and walk us through how disease surveillance systems work and 
what can be done to improve them and our nation's ability to 
detect bioterror attacks. With passage of the Bioterrorism Act 
of 2002 and subsequent appropriations, Congress has invested 
over $2 billion in bioterrorism preparedness and response. The 
bulk of that money has gone to the Center for Disease Control 
which spent over $1 billion upgrading public health laboratory 
capacity. Some of this money was spent to update and modernize 
many State and public health labs and computer equipment for 
improved communications ability. The CDC has been working to 
establish several information surveillance systems to move 
disease reporting from a paper-based system to one that 
capitalizes on new technologies. We hope to learn what sort of 
real-time analysis capabilities exist within our system today.
    Again, in the fiscal year scheduled to start next week, we 
will likely invest close to another $1 billion in bioterrorism 
preparedness grants. As members of this committee have 
discovered over the past 6 months, communication is critical in 
our ability to successfully secure the homeland. For these 
disease surveillance systems to work, people must be willing 
and able to communicate. Healthcare professionals will have to 
be able to share information because CDC's ability to connect 
the dots is largely dependent upon the quality and the quantity 
of the information that is collected.
    Last, what is the role of technology? How can we capitalize 
on America's ingenuity and our unparalleled advances in health 
research? I hope that Dr. Trent from own State of Arizona will 
be able to shed some light on this important aspect, given his 
experience serving as direct of the National Human Genome 
Research Institute at the NIH, and his current experience 
working on pathogen diagnostics at the Translational Genomics 
Research Institute.
    I am pleased to have the panel with us today. By agreement, 
we have agreed to limit the opening statements to the Chairman 
and the Ranking Member of both the subcommittee and the full 
committee. I will now turn to the Ranking Member of the 
subcommittee, Mr. Thompson, for his opening statement.
    Mr. Thompson. Thank you, Mr. Chairman.
    Almost 2 years ago, the Congress faced head-on the impacts 
of bioterrorism when both the Senate and House were infected 
with a weaponized strain of anthrax sent through the U.S. mail 
system. The lives that were lost as a result of this terrorist 
attack were a terrible tragedy, and we must never forget our 
experiences during the response to that attack. It is critical 
that Congress and the Administration work to ensure that in the 
event of future bio-attacks we do everything within our power 
to prevent the loss of life and to identify those responsible 
for those unconscionable acts of terrorism.
    Therefore I am pleased to have the distinguished witnesses 
with us to describe the role of disease surveillance systems in 
our preparedness for and in response to acts of bioterrorism. I 
am very interested in the testimony we will hear today and I 
hope that our witnesses would discuss both the recent advances 
in disease surveillance systems and perhaps more important, the 
need for additional resources or focus on the issue in order to 
ensure that we are fully prepared for the next bioterrorism 
incident.
    As we will hear from our witnesses today, the Center for 
Disease Control and Prevention, RCDC, manages a complex 
national network of surveillance systems designed to monitor 
the emergence of certain diseases such as the flu. However, I 
remain concerned about the capabilities of our disease 
surveillance system because they represent the first line of 
defense to responding to acts of bioterrorism. These systems 
will provide us with the first indication that there is a 
problem, and will guide our response to that incident. A robust 
surveillance system will also allow us to quickly get vital 
information out to the public health providers and the public 
at large about a disease outbreak, and will help prevent the 
further spread of disease.
    When a person becomes ill, he or she most often seeks 
treatment from a primary care physician. However, there are 
significant communication disconnects between individual 
doctors and the public health community in reporting diseases. 
If surveillance is to work effectively, doctors must report 
timely and accurate diagnoses in a standardized manner. In 
2000, the Institute of Medicine convened workshops to follow 
their report emphasizing this point. For example, even when 
individual doctors are required by law to report certain 
diseases such as flu, they are, according to the Institute, 
notoriously lax in reporting such information to the public 
health authorities. One of the issues I will ask later is, when 
they are lax, what do we do? Slap them on the wrist, or just 
say better luck next time?
    We must move faster, Mr. Chairman, and we must be stronger 
in our efforts to protect and defend the United States of 
America against acts of bioterrorism. I hope the testimony we 
hear today will assist us in developing a roadmap for doing so.
    Mr. Shadegg. Thank you.
    I call upon the Chairman of the full committee, Chris Cox, 
for his opening statement. Chairman Cox?
    Mr. Cox. Thank you, Mr. Chairman. I want to thank you for 
assembling a fine panel to assist us today in considering how 
disease surveillance system can be of better use in the war on 
terror.
    We know from several commissioned studies that we had 
information prior to 9-11 that, had we only pieced it together 
differently, might have permitted us, if not to learn of the 
terrorist plot before it was executed, at least to interrupt 
it. We might have taken enough of the individuals who were 
involved in it out of commission so that 9-11 might not have 
happened. Our government and the American people possessed 
information that they just did not put together because we were 
not thinking about this problem in this way.
    We have I think the same problem presented to us today. 
Happily, the United States has not been hit with a bioterror 
attack on the scale that we saw on September 11, but I have to 
forecast that were such an attack to occur today, we have 
commissioned reports on its aftermath that would tell us that 
we did not piece together the information that we had in the 
early moments of that crisis that would have permitted us to 
respond to it and prevent it from causing the damage that 
ultimately it would carry out.
    We can learn, and this committee will learn when we have a 
complete report on Top-Off 2 from exercises. We know that our 
emergency room physicians are going to be heavily involved in 
the early stages of response. We also know that our emergency 
rooms are very overcrowded. They are going to be especially 
overcrowded when people are all coming at a time of crisis. We 
have to consider how the emergency rooms not only are going to 
put information into this system so it can be analyzed and 
dispersed across the nation rapidly, but also how they are 
going to respond if called upon to do so.
    At least some of the testimony that we will hear today is 
going to ask us to take a look at the role of primary care 
physicians. The truth is that we have not been accustomed to 
thinking of primary care physicians as first responders in the 
same fashion that we have the ER physicians, but we know from 
Top-Off 2 and we know from the fact that our emergency rooms 
are overcrowded that they will be. As a matter of fact, they 
will be in the first line of casualties if they are not 
properly inoculated. This, too, is something that we have got 
to take a look at.
    What we will learn today from the testimony that our 
witnesses have already provided to us, and even more so from 
the interaction during questioning, is that there is a lot that 
we can do with data collection and dispersal and analysis. 
There is also a question then that will remain for our 
committee, and that is what exactly should be the role of the 
Department of Homeland Security in taking advantage of these 
good ideas and carrying them into effect.
    So I want to congratulate you, Mr. Chairman, for placing a 
focus on bioterrorism before it happens in this committee, and 
for assembling this panel of expert witnesses.
    Thank you, Mr. Chairman. I yield back.

    PREPARED OPENING STATEMENT OF THE HONORABLE CHRISTOPHER COX, A 
REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA, AND CHAIRMAN, 
                 SELECT COMMITTEE ON HOMELAND COMMUNITY

    I would like to thank Chairman Shadegg and ranking member Thompson 
for their leadership in organizing today's hearing and recognizing the 
enormity of the bioterror threat. Many of us gathered here today 
witnessed first hand the effects ofbioterrorism in the fall of 2001, 
when Congress became a target of a biological attack. However, we are 
fortunate that only about 22 people were exposed to Bacillus anthracis, 
and as tragic as' any death is, that no more than 5 people died. One of 
the lessons that we learned from that event was that bioterrorism does 
not need a large body count to terrify our citizens, damage our 
economy, and threaten our democracy. Any terrorist with minimum 
technical sophistication and with some basic microbiology tools can 
accomplish the goal of bioterror- to inflict enormous social and 
economic disruption.
    The recent SARS outbreak has taught us that natural emerging and 
reemerging diseases can cause widespread economic losses, devastating 
death tolls, and a heavy strain on the public health infrastructure. 
This outbreak provides a window into the damage that can be done by 
a"thinking" enemy using a biological weapon with a deliberate plan to 
harm our citizens.
    It should be noted that of the almost 8,500 SARS cases world wide 
and almost 800 deaths, the US reported no deaths during this outbreak. 
This is a direct credit to our front line clinicians, public healthcare 
workers and the leadership of Secretary Thompson in providing nearly $1 
billion dollars from the Department of Health and Human Service over 
the past year for States and localities to develop bioterrorism 
response capabilities.
    The members of this Committee, just last Spring, worked in a strong 
bipartisan manner to pass the President's BioShield legislation. This 
legislation not only provides for DHS and HHS to collaborate to provide 
countermeasures for potential biological weapons, but it also 
incentivizes the private sector to leverage its superior technology to 
produce vaccines and other countermeasures to help protect our 
citizens. Already, our focus in this area is paying dividends; recently 
we learned of a breakthrough in developing a vaccine against Ebola, a 
virus for which there is no other treatment. As a nation, we are making 
concrete strides in developing countermeasures and the technology to 
better prepare ourselves for a potential bioterror attack.
    Our best defense, of course, is early detection. The sooner we have 
the capability to detect a bioterror attack, the more time we will have 
to intervene and lessen the effects on our society. I look forward to 
the testimony that each of you will offer in the area of early 
diagnosis and the status of public health systems, which will screen 
for trends in large numbers of patients. Early recognition is crucial 
to curbing the spread of a bioterror attack and administering 
treatments.
    The dedication that each of you have shown in this area not only 
enhances our capability to respond effectively to a bioterror event but 
strengthens our healthcare infrastructure and the capacity to deal with 
natural epidemics.

    Mr. Shadegg. I thank the gentleman for his opening 
statement. I now call upon the Ranking Member of the full 
committee, the gentleman from Texas, Mr. Turner.
    Mr. Turner. Thank you, Mr. Chairman.
    I appreciate our distinguished panel being with us today. 
In my view, the threat of biological attack is perhaps the most 
troubling, the most disturbing, potentially most catastrophic 
event that could ever occur as a result from terrorism. I am 
also firmly of the opinion that as we try to deal with the 
threat of terrorism, that we have to look further ahead into 
the future and anticipate what our terrorist enemies may try to 
do and have the capability to do in the future, than we are 
today.
    For that reason, I commend the Chairman for his foresight 
in holding this hearing. There is no doubt that if we are going 
to plan to deal with bioterrorism, we have to start working on 
it now.
    I also believe that when we look at bioterrorism, we know 
that we probably have a greater need to make a commitment of 
financial resources today than in any other area in terms of 
the terrorist threat. When we reviewed our legislation that 
this Committee dealt with just a few weeks ago, Project 
Bioshield, we were acutely aware that that legislation dealt 
with the tail-end of the vaccine production inresponse to a 
bioterrorist attack. What I think we need to be doing a better 
job of is dealing with the front end--dealing with the 
development of detection capabilities and developing the 
response capacities to biological pathogens that our terrorist 
enemies may be able to produce.
    There is no question that trying to defeat bioterrorism up 
front is very difficult, because it can all be done within the 
confines of a small lab and spread by humans who may travel 
into our country by air or other method, and simply walk around 
among our populace, infecting literally tens of thousands of 
people in a very short period of time. So this is a threat that 
we must take very seriously. I am very pleased that our panel 
is here today to help us with this most important challenge. I 
am confident that with your help, we can bring the right amount 
of public and congressional attention to this issue to allow us 
to begin to move forward on an issue that we must address now. 
It not only deals with our survival, but perhaps the survival 
of the entire world.
    So thank you, Mr. Chairman, for calling this hearing today.
    Mr. Shadegg. I thank the gentleman for his opening remarks.
    Without objection, the opening statements of all members 
will be included in the record. In that regard, I would ask 
unanimous consent to enter the opening statement of our 
colleague Mr. Gibbons who could not be with us here today. 
Without objection, so ordered.
    I also ask unanimous consent that Mrs. Dunn, the Vice 
Chairman of the full committee, be allowed to sit and ask 
questions at today's hearings. Without objection, so ordered.
    Now, to address the topic of disease surveillance systems 
and how they can help us prepared for bioterrorism, it is my 
privilege to welcome and introduce our distinguished panel. 
First, we have Joseph Henderson, associate director of 
terrorism preparedness and response at the Centers for Disease 
Control. Thank you for being here. Next is Janet Heinrich, 
pubic health specialist at the General Accounting Office; Dr. 
Richard Platt, chair of the Ambulatory Care and Prevention 
Department at Harvard Medical School and Harvard Pilgrim Health 
Plan. Thank you for being here. Dr. Jonathan Temte, infectious 
disease specialist with the American Academy of Family 
Physicians and associate professor at the University of 
Wisconsin; Dr. Jeffrey Trent, president and scientific director 
of T-Gen, the Translational Genomics Research Institute.
    Ladies and gentlemen, we appreciate your being here today. 
At this point, we would appreciate your opening statements. We 
will not hold you strictly to 5 minutes, but hope that you will 
endeavor to stay somewhere close to that time limit.
    [The statement of Mr. Gibbons follows:]

               PREPARED STATEMENT OF THE HON. JIM GIBBONS

    Mr. Chairman, thank you for your leadership and the insight to 
establish a panel with such knowledge on this critically important 
issue. I welcome the members of the panel and look forward to the 
information they will provide on the best proactive techniques and 
measures available to improve homeland security.
    Different from biologic warfare which attempts to kill, 
bioterrorism thrives on public fear, potentially immobilizing or 
demoralizing a population. Countering such fears are public knowledge, 
and purposeful scientific and political pre-event action.
    In the years since the attacks on the World Trade Center and the 
Pentagon, in big cities and in small towns, on bridges and at border 
crossings, Americans have been mustering resources in preparation for 
an assault from the shadows, recalculating the realm of possibilities.
    In a sense, the effort to shore up the home front against terrorism 
is an exercise in seeking balance: between added security and reduced 
openness and convenience; between the likelihood a threat might 
materialize and the cost of eliminating it..
    Bioterrorism involves the intentional or threatened uses of 
viruses, bacteria, fungi, toxins from living organisms, or chemicals, 
to produce death or disease in humans, animals, or plants. Many 
biological agents could be used to make weapons, however most experts 
agree that only a limited number of well-known biological agents would 
cause widespread illness and death.
    As I understand the process, an announced event will be evaluated 
at the time by primary health care providers, public health and law 
enforcement. An unannounced event will be detected by private health 
care providers, infection control and/or public health surveillance as 
an unusual disease or death occurrence, once the disease starts to 
manifest itself in the victims. Prompt recognition and reporting is 
important to prevent spread and control future cases.
    The Question we seek answers to today: How do best identify a 
bioterrorist attack and minimize the post-action effects?
    Again, I welcome our witnesses and look forward to their keen 
perceptions on the latest disease surveillance systems.

    Mr. Shadegg. We will begin with you, Mr. Henderson.

   STATEMENT OF MR. JOSEPH HENDERSON, ASSOCIATE DIRECTOR FOR 
   TERRORISM PREPAREDNESS AND RESPONSE, CENTERS FOR DISEASE 
                            CONTROL

    Mr. Henderson. Good afternoon, Mr. Chairman and members of 
the subcommittee. I am Joseph Henderson, director of the Office 
of Terrorism Preparedness and Emergency Response at the Centers 
for Disease Control and Prevention. I am accompanied by Dr. 
John Loonsk who is CDC's associate director for informatics.
    Thank you for this opportunity to discuss how disease 
surveillance systems can help to detect a potential terrorist 
attack. Disease surveillance systems or disease detection 
systems address one important aspect of our nation's overall 
public health preparedness strategy. The CDC, working with our 
Federal, State and local partners, is working to build systems 
that can rapidly detect an outbreak or an attack in our 
communities, mobilize the appropriate response to contain the 
event, and assure that our affected communities return to a 
sense of normalcy following the attack.
    As requested by the subcommittee, I will focus on the rapid 
detection component of this overall preparedness system. 
Surveillance for diseases in the population is best described 
as the ongoing identification, reporting, collection, analysis 
and dissemination of critical public health data. These data 
inform public health officials of disease in their communities, 
enabling them to intervene, leading to control and containment 
of the disease. Without these systems, intervention would be 
significantly delayed, having much higher impact by way of 
increased illness, injury and in some cases death.
    Recent events such as SARS and monkeypox have underscored 
the essential role early detection systems play in mobilizing 
rapid response. Detection of a disease almost always occurs at 
the local level where healthcare professionals and encounter 
patients seeking medical assessment or treatment. A clinician's 
ability to quickly recognize and identify symptoms of unusual 
illnesses on the frontline has been critical to CDC's ability 
to recognize unfolding disease events and implement containment 
measures.
    Today, I will address three critical components of our 
disease detection systems: our current state of national 
disease detection capability; the public health information 
network which is our IT framework to enable and amplify 
detection and reporting capacities; and I will provide a brief 
glimpse of our global disease detection initiatives. I will try 
to do this within 5 minutes.
    The most vital link in our current disease detection and 
reporting chain is the trained and astute clinician who would 
be the first to assess and diagnose individuals who are ill 
requiring care and treatment. CDC has been working with our 
State and local public health agencies, school and universities 
and numerous professional organizations across the country to 
educate our nation's health protectors. Frontline workers armed 
with the appropriate knowledge and information allows for rapid 
disease detection in our communities, whether naturally 
occurring or intentional, such as an act of terrorism. 
Clinicians and laboratorians report diseases to State and local 
agencies, in many cases required by law, which in turn share 
information with the CDC. The CDC and our State and local 
public health colleagues define conditions that should be 
reported and develop and disseminate guidelines to healthcare 
providers, infection control practitioners, emergency 
department physicians, laboratorians, and other members of the 
healthcare system to enable effective reporting.
    However, improvements are necessary to do this work faster 
and with a higher degree of accuracy. Many local reporters of 
disease still report to public health agencies via fax. 
Reporting systems are largely paper-based and burdensome to all 
levels of the reporting effort. A comprehensive surveillance 
system requires a strong foundation at all levels of local, 
State and Federal public health agencies. Since September 11, 
2001, the Administration had budgeted for and Congress has 
approved over $2 billion to develop and sustain State and local 
public health readiness, specifically to enhance capacities to 
detect, respond, contain and recover from biological, chemical 
and radiological acts of terrorism and other public health 
emergencies. States are spending significant portions of these 
funds to enhance epidemiological and event detection capacities 
and to develop and leverage information technology and systems 
to support various public health functions. A number of 
examples of these efforts can be found in my written statement.
    For many years, CDC has supported the development and 
implementation of information technology systems for State and 
local health agencies to improve the practice of public health. 
Many of these systems operate in isolation, not capitalizing on 
the potential for cross-fertilization of data exchange. A 
cross-cutting and unifying framework is needed to better 
integrate these data systems to support early detection of 
public health conditions and emergencies. The Public Health 
Information Network, or PHIN, provides this framework. The PHIN 
will enable consistent collection and exchange of response, 
health and disease tracking data among public health partners.
    PHIN encompasses four components: detection and monitoring; 
analysis and interpretation; information dissemination and 
knowledge management; and public health response, which is 
described here on this poster. I will briefly describe each of 
these particular components.
    Detection and monitoring. The CDC is in the proof of 
concept stage for a project called BioSense, which proposes 
early event detection associated with a possible bioterrorist 
threat. BioSense could establish the capability for rapid, 
around-the-clock electronic transmission of data to local, 
State and Federal public health agencies from national, 
regional and local health data sources such as clinical 
laboratories, hospital systems, health plans, the Department of 
Defense, VA medical treatment facilities, and pharmaceutical 
chains.
    This proposal is based on utilizing existing data and 
information so as not to add to existing reporting burdens. The 
National Electronic Disease Surveillance System, or NEDSS, is 
another system that falls under the PHIN framework, supporting 
the development of real-time reporting of information for 
public health action. NEDSS requires adherence to standards-
based approaches such as Federal e-government standards to 
ensure data and information are collected and disseminated as 
effectively and as efficiently as possible. The CDC strategy 
for implementation of the NEDSS system is to allow State and 
local health agencies to develop their own systems compatible 
with the established standards or utilize a CDC-developed 
version of NEDSS.
    Currently, two States have fully implemented the CDC NEDSS 
system and 30 other States have requested assistance from CDC 
in installing this particular system. Other State and local 
health agencies continue to build or modify their disease 
surveillance systems to conform to our national standards.
    Analysis and interpretation. CDC depends on its scientific 
and epidemiological expertise to interpret the volume of data 
received to ensure accurate conclusions are developed and 
disseminated to public health colleagues in a timely manner to 
impact health decisions. To ensure this effort is robust and 
can effectively deal with the increasing amount of data and 
information CDC receives, a bio-intelligence center is being 
conceptualized. This center would provide a centralized 
approach to analyzing and interpreting data and information, 
and will enable communications to ensure that this information 
and the conclusions drawn from the analysis are provided back 
to State and local health officials to enable appropriate 
action and support decisionmaking.
    Information dissemination and knowledge management. Within 
this component of PHIN is CDC's health alerting capability, 
formally referred to as the Health Alert Network. Through this 
system CDC has the capacity to reach all State and local health 
officials and many other key responders such as hospitals, 
before, during and after any crisis that occurs within our 
communities. This system has been used to alert our colleagues 
of public health threats and emergencies over 150 times since 
September 11, 2001, reaching over 1.5 million recipients. Most 
recently the alerting capability was used to communicate 
critical health information in response to Hurricane Isabel.
    CDC, through the PHIN, also supports the Epidemic 
Information Exchange Program, or EPI-x. EPI-x facilitates 
critical public health communication through a secure network 
between and among public health responders. Currently, there 
are approximately 1,800 users to subscribe to this service 
nationally.
    Public health response. Since the majority of data 
management needs come after a disease is detected, CDC through 
the PHIN framework is developing new and improved systems to 
support public health response. Primarily, these efforts are 
supporting CDC's emergency operations, outfitting deployed 
staff with state-of-the-art information management tools, and 
supporting State and local efforts. These systems have been 
used to support the SARS outbreaks and special events such as 
the 2002 Winter Olympics in Salt Lake City. CDC has also 
developed the Pre-Event Vaccine System to support the National 
Smallpox Vaccination Program, which has proved and continues to 
prove to be a valuable information management tool.
    The emergence of SARS, a previously unrecognized infectious 
disease, has provided a strong reminder of the threats posed by 
emerging infectious diseases and their global impact. CDC 
continues to build upon our strong relations with the World 
Health Organization, the Pan American Health Organization, and 
many other global partners to create a comprehensive global 
disease detection and reporting network. Currently, CDC has 
field epidemiology training programs, we call them FETPs, in 30 
countries, supporting disease detection, providing an essential 
link in global surveillance.
    CDC has also created two International Emerging Infections 
Programs, one in Thailand, which we created in 2001, and one in 
Kenya, which is projected to be up and running by the end of 
this calendar year. These programs will help to foster the next 
generation of international public health leaders, while 
providing high-quality disease surveillance data and rapid 
response capacity for new and emerging diseases.
    This year we are also providing increased levels of funding 
to enhance disease detection and response capacity with our 
Mexican and Canadian neighbors to enhance the disease 
surveillance over the borders.
    In conclusion, CDC is committed to working with Federal, 
State and local partners to protect the nation's health. Our 
best public health strategy against disease is to develop the 
systems needed to rapidly identify the causative organism, and 
then unleash a control and containment strategy that will 
minimize illness and death. Keep in mind that the astute 
clinician remains the critical link in this disease detection 
and reporting strategy. The first case of West Nile virus in 
1999 and the first case of anthrax reported in early October 
2001 were identified by these astute clinicians. Training and 
education of these frontline health protectors remains a high 
priority for the Department of Health and Human Services and 
CDC, and will continue to be a priority as we strive to improve 
all components of the nation's disease detection system. While 
we have made substantial progress towards enhancing the 
nation's capability to rapidly detect diseases within our 
communities, respond and contain outbreaks of disease, and 
recover from these tragic events, much remains to be done. CDC 
is extremely grateful for the congressional support received to 
date and looks forward to working with members of Congress, 
especially this committee, as we strive to protect the public's 
health from terrorism and other public health emergencies.
    Thank you for your attention. I would be happy to take 
questions.
    [The statement of Mr. Henderson follows:]

            PREPARED STATEMENT OF JOSEPH M. HENDERSON, M.P.A

               CDC's Disease Surveillance Systems Efforts

    Good morning, Mr. Chairman and Members of the Subcommittee. I am 
Joseph M. Henderson, Director of the Office of Terrorism Preparedness 
and Emergency Response at the Centers for Disease Control and 
Prevention (CDC). As the nation's disease prevention and control 
agency, CDC, working with state and local public health agencies is 
charged with detecting and responding to illnesses, both man-made and 
naturally occurring. This task is an integral part of CDC's overall 
mission to monitor and protect the health of the U.S. population.
    Thank you for the opportunity to discuss how disease surveillance 
systems can prepare the nation for potential terrorist threats. 
``Disease surveillance systems'' or disease detection systems, address 
one important aspect of our nation's overall public health 
preparedness. CDC, working with our federal, state, and local partners 
is working to build systems that can: (1) rapidly detect an event in 
our communities; (2) mobilize the appropriate response to contain the 
event, and (3) ensure affected communities return to a sense of 
normalcy. These are what we refer to as our foundations of public 
health readiness. My testimony will focus on rapid detection of an 
event, which is the topic of discussion for this sub-committee today.
    National disease detection can best be described as the ongoing 
collection, analysis and dissemination of public health data related to 
illness and injury. These ongoing data collection and analysis 
activities enable public health officials to detect disease early, thus 
resulting in faster intervention to control and contain the 
consequences created by the causative agents. Without these early 
detection systems, the consequences of outbreaks of infectious disease 
and human exposures to agents such as chemicals and radiation would 
take a much greater toll by way of increased illness, injury, and in 
some cases death. Recent events, such as the SARS and Monkeypox 
outbreaks, have underscored the essential role early detection systems 
play in mobilizing rapid response. Detection of a disease almost always 
occurs at the local level where health care professionals encounter 
patients seeking medical assessment or treatment. A clinician's ability 
to quickly recognize and identify symptoms of unusual illnesses on the 
frontline has been critical to the CDC's ability to recognize unfolding 
disease events and implement containment measures to prevent further 
spread of disease, thus mitigating further harm to the public. Today, I 
will address three critical components of our disease detection 
systems: (1) Current state of national disease detection systems; (2) 
the Public Health Information Network--PHIN; and (3) global disease 
surveillance.
Current State of National Disease Detection Systems
    One key to successful defense against any threat to the nation's 
public health, whether naturally occurring or deliberately caused, 
continues to be accurate, early recognition of the problem.
    Awareness and diagnosis of a condition by a clinician or laboratory 
is a key element of our current disease detection systems. Clinicians 
and laboratories report diseases to state and local health departments, 
which in turn share information with CDC. CDC works with its public 
health partners to define conditions that should be reported 
nationally. Health departments share these definitions and guidelines 
with health care providers, infection control practitioners, emergency 
department physicians, laboratorians, and other members of the health 
care system to ensure accurate and timely reporting.
    Many local reporters of disease incidence still report to public 
health authorities on paper via facsimile. If a case of illness is 
particularly unusual or severe (such as a case of anthrax), the local 
health care worker may call the local health department immediately to 
report the case. Current reporting systems are largely paper-based and 
burdensome to both providers and health departments, often resulting in 
reports which are neither complete nor timely. In addition to initial 
detection, these detection and reporting systems play a pivotal role in 
the detection of subsequent cases and help support the management of 
the event once a response/investigation are initiated. Such information 
is vital to coordinating response decisions, which ultimately lead to 
the containment of an outbreak.
    A comprehensive surveillance system requires a strong foundation at 
all levels of local, state, and federal public health agencies. CDC has 
been working with state and local health agencies for many years to 
build the public health infrastructure to improve disease detection and 
reporting systems. Since September 11, 2001, the Administration has 
budgeted for and the Congress has appropriated over $2 billion to 
develop and sustain state and local public health readiness, 
specifically to enhance capacities to detect, respond, contain and 
recover from biological, chemical, and radiological acts of terrorism. 
States estimate that they are spending significant portions of this 
funding in both fiscal year 2002 and fiscal year 2003, to: 1) enhance 
epidemiological and surveillance capacity and 2) develop and leverage 
information technology and systems to support various public health 
functions.

    Some examples of how states used their funding in these areas 
include:
         Michigan has begun implementation of a secure web-
        based disease surveillance system to improve the timeliness and 
        accuracy of disease reporting.
         Missouri has implemented a new hospital tracking 
        system to detect possible outbreaks by monitoring the number of 
        patient admissions and ambulance diversions at hospitals. This 
        system provides a way for hospitals to obtain instant messages 
        and alerts.
         Virginia, Maryland, Washington DC, and Pennsylvania 
        are all developing early warning systems based on symptom data 
        from emergency departments to detect unusual patterns of 
        illness and automatically alert hospitals and public health 
        agencies when the incidence of disease exceeds a critical 
        threshold. Use of such early warning systems might enable the 
        earliest possible response and intervention before an outbreak 
        or epidemic spreads.

    Other related activities useful for early detection of emerging 
infections or other critical biological agents include CDC's Emerging 
Infections Programs (EIP). Through the EIP, state and local health 
departments receive funds to conduct population-based surveillance that 
goes beyond their routine function to develop ``next generation'' 
surveillance science, and often involves partnerships among public 
health agencies and academic medical centers. In addition, CDC has 
established networks of clinicians that serve as ``early warning 
systems'' for public health by providing information about unusual 
cases encountered in the clinical practices. As noted earlier, these 
relationships, particularly between health care providers and local 
health departments, are the foundation on which disease detection 
systems operate.

Public Health Information Network
    For many years CDC has made significant achievements in building or 
enabling state and local health agencies to build information systems 
that support the practice of public health. However, many of these 
systems operate in isolation, not capitalizing on the potential for a 
cross-fertilization of data exchange. A crosscutting and unifying 
framework is needed to better integrate these data streams for early 
detection of public health issues and emergencies. The Public Health 
Information Network (PHIN) provides this framework. Through defined 
data, vocabulary standards and strong collaborative relationships, the 
PHIN will enable consistent collection and exchange of response, 
health, and disease tracking data among public health partners. 
Ensuring the security of this information is critical as is the ability 
of the network to work reliably in times of national crisis. PHIN 
encompasses four key components: (1) detection and monitoring;(2) 
analysis and interpretation; (3) information dissemination and 
knowledge management; and (4) public health response. Each of these 
components is briefly described below.
    Public health information systems must support functions that 
include:
         Early event detection--BioSense is being developed to 
        support early event detection activities associated with a 
        possible Bioterrorism threat. Regional health data will be sent 
        to authorized health officials detailing health trends that 
        could be related to a possible Bioterrorism attack.
         Routine public health surveillance--NEDSS supports 
        routine surveillance activities associated with the rapid 
        reporting of disease trends to control outbreaks. The NEDSS 
        platform allows states to enter, update and electronically 
        transmit demographic and notifiable disease data.
         Secure communications among public health partners--
        Epi-X technology allows for the secure exchange of 
        communications between participating public health partners via 
        the web by providing up-to-the-minute information, reports, 
        alerts, and discussions about terrorist events, toxic 
        exposures, disease outbreaks, and other public health events.
         Management and dissemination of information and 
        knowledge--HAN's architecture upgraded the capacity of state 
        and local health agencies to communicate different health 
        threats such as emerging infectious and chronic diseases, 
        environmental hazards, as well as Bioterrorism related threats.
         Other functions include--Analysis and interpretation 
        of relevant public health data and public health response 
        systems.
    PHIN will provide the framework for these functions to serve as 
part of an integrated and interoperable network critical in 
establishing a more effective public health system.

Detection and Monitorinq
    The CDC is in the proof-of-concept stage of BioSense--a proposal in 
development to enhance early event detection for public health 
emergencies such as bioterrorism. BioSense is proposed to enhance the 
nation's capabilities to rapidly detect and quantify public health 
emergencies by enabling rapid access to, and analysis of, diagnostic 
and pre-diagnostic health data. BioSense could establish the capability 
for rapid, around the-clock electronic transmission of data to local, 
state and federal public health agencies from national, regional and 
local health data sources such as clinical laboratories, hospital 
systems, health plans, DoD and VA medical treatment facilities, and 
pharmacy chains. Many of the pre-diagnostic data sources need to be 
rigorously evaluated to determine which are most effective, but 
importantly, the initiative is based on the use of existing data and 
will not add to the reporting burden of clinical care or other 
healthcare professionals. BioSense data would not include patient names 
or personal identifiers, but may allow for the identification of early 
signs of a possible bioterrorist attack and facilitate appropriate 
public health investigation and follow-up by public health authorities. 
As proposed, BioSense will provide public health professionals a daily 
picture of normal diagnostic and therapeutic activities, provide 
indications of abnormal activities and also provide a way to rapidly 
investigate events to discern true concerns from false alarms.
    Some early detection activities are currently occurring in local 
jurisdictions. BioWatch, which is a locally managed activity, is one 
source of data supporting BioSense. BioWatch involves the deployment of 
environmental air samplers in key locations throughout a city. Filters 
from these air samples are routinely gathered and analyzed by public 
health laboratories to determine if a potential release of a biological 
agent has occurred. Currently, many metropolitan areas within the 
United States participate in this project which is led by the 
Department of Homeland Security with support from CDC and our state and 
local public health partners.
    CDC has initiated the development of the National Electronic 
Disease Surveillance System (NEDSS) which is a part of PHIN. The 
ultimate goal of NEDSS is the electronic, real-time reporting of 
information for public health action. NEDSS will include direct 
electronic linkages with the health care system allowing medical 
information, such as diagnostic tests, to be shared electronically with 
public health officials as soon as a clinical laboratory receives a 
specimen or makes a diagnosis of a condition of public health 
importance.
    NEDSS integrates the numerous existing disease detection and 
monitoring systems using a standards-based approach with standards for 
data, information architecture, security, and information technology. 
This adherence to standards will ensure that data be entered once at 
the point of patient care, without a need for re-entry of data at each 
level of reporting. Use of standards is critical in ensuring that 
public health practices use technology more effectively and 
collaboratively. The NEDSS strategy provides for state implementation 
of the CDC-developed version of NEDSS or state systems compatible with 
NEDSS. Some states are building their own NEDSS compatible systems. Two 
states have fully implemented the CDC NEDSS system and thirty other 
states have requested installation of the CDC-developed system.
    As NEDSS progresses, we need to ensure that the data standards we 
use are compatible with those used in the health care delivery system. 
This will ensure ease of adaptation to future advancements in the field 
and ease of use for all levels of the clinical and public health 
systems. Moreover, NEDSS is fully consistent with Secretary Thompson's 
recently announced Consolidated Health Informatics (CHI) standards. 
These are health data interoperability standards established under one 
of the Administration's electronic government projects covering the 
federal health care enterprise. In addition, a standard information and 
security architecture will enable public health partners to share data 
while ensuring patients' privacy. The reliance on industry standards 
for information technology ensures the ability to interface with 
multiple commercial products to meet the needs of the public health 
community, including state-of-the-art analytic tools and geographic 
information system capacity.

Analysis and Interpretation
    CDC depends on its scientific and epidemiological expertise to 
interpret the volume of data received to ensure accurate conclusions 
are developed and disseminated to our public health colleagues in a 
timely manner to impact public health decisions. As we develop more 
integrated systems and open new channels of data and information, more 
powerful tools and systems will be needed to rapidly and accurately 
perform this critical public health task. CDC's concept of this effort 
is a Bio-Intelligence center or BIC. The center would provide a 
centralized approach to analyzing and interpreting data and information 
and will assure appropriate communication channels are established to 
provide this information and analysis back to state and local health 
officials. In fiscal year 2004, CDC will continue to develop and 
investigate this concept.

Information Dissemination and Knowledge Management
    Since September 11,2001, the anthrax attacks, and more recently the 
SARS and Monkeypox outbreaks, the general public, the first responder 
community, laboratory professionals, and our state and local partners 
have become more and more reliant upon the CDC website (www.cdc.gov) 
for critical public health information and knowledge resources. CDC 
will continue to refine this national resource as we improve our 
ability to provide information across the web.
    Within this particular component of the PHIN is CDC's health 
alerting capability(formerly referred to as the Health Alert Network). 
Through this program all fifty states, four large cities and eight 
territories are receiving funding and technical assistance from
    CDC to strengthen core infrastructure for information access, 
communications, and training at the community level. This effort has 
built the foundation nationwide for: 1) continuous, high-speed Internet 
connectivity to support rapid information access; 2) broadcast capacity 
to support emergency communication; and 3) distance-learning 
infrastructure to support just-in-time training.
    On September 11, 2001, CDC issued the first Health Alert Network 
message advising state and local health agencies of the need to enhance 
their disease detection systems to look for any unusual signs or 
symptoms related to a bioterrorist event. Since 9/11, CDC has issued 
over one-hundred fifty health alerts and advisories reaching 1.5 
million health care professionals, as well as other first responder 
communities, on topics such as bioterrorism, West Nile virus, SARS, 
patient safety, and smallpox vaccination. Over 95% of our nation's 
public health agencies have the capability to receive and/or further 
distribute critical health alerts to their community stakeholders. The 
ability to access the web has allowed state and local health 
departments to utilize CDC's web based resources including CDC's secure 
communication system, Epi-X.
    Epi-X (the Epidemic Information Exchange) is CDC's secure web-based 
communications system for public health professionals. This network 
provides secure communication of preliminary information regarding new 
health threats to a limited audience of authorized public health 
officials. Epi-X was created to provide a single source of up-to-the-
minute alerts, reports, discussions, and comments contributed by their 
peers, and it is moderated by medical epidemiologists at CDC. Its 
primary goal is to inform health officials about important public 
health events, help them respond to public health emergencies, and to 
encourage exchange of information. Through Epi-X, health officials at 
CDC, other federal agencies, state and local health departments, poison 
control centers, and the military share preliminary health surveillance 
information--quickly and securely. Users are notified immediately of 
breaking health events as they occur. Currently, Epi-X has 
approximately 1800 users nationwide. Since its inception in December 
2000, health officials have posted approximately 1500 reports of 
disease outbreaks. Epi-X highlights include local and national 
responses to terrorism, responses to emerging diseases such as severe 
acute respiratory syndrome (SARS) and monkeypox, West Nile virus 
surveillance, influenza surveillance, foodborne outbreaks and food 
recalls that affected residents in multiple states, and investigations 
of travelers with contagious illnesses.

Public Health Response
    Since the majority of the data management needs come after disease 
is detected, CDC through PHIN is investing in information systems to 
support our public health response teams, our Director's Emergency 
Operations Center in Atlanta and to assist state and local health 
agencies in tracking and managing vital public health information 
before, during, and after an event has occurred. These systems have 
been used to support the SARS outbreak, special events such as the 2002 
Winter Olympics in Salt Lake City, and other events that could 
potentially be targets of a terrorist attack.

Global Disease Surveillance
    The emergence of SARS, a previously unrecognized infectious disease 
outbreak, has provided a strong reminder of threats posed by emerging 
infectious diseases. In March 2003, the Institute of Medicine (I0M) 
published Microbial Threats to Health: Emergence, Detection, and 
Response, a report describing the spectrum of microbial threats to 
national and global health, factors affecting their emergence or 
resurgence, and measures needed to address them effectively. Although 
much progress has been made, especially in the areas of strengthened 
surveillance and laboratory capacity, CDC is taking steps to make 
further improvements both domestically and internationally.
    CDC is intensifying its efforts to work with the World Health 
Organization (WHO) and other partners to create a comprehensive global 
network that detects and controls outbreaks before they grow into 
worldwide pandemics. Currently, there are Field Epidemiology Training 
Programs (FETP's) in thirty countries throughout the world that support 
disease detection activities and provide an essential link in global 
surveillance. The FETP program is modeled after CDC's Epidemic 
Intelligence Service (EIS) training program which focuses on training 
public health practitioners in epidemiology and surveillance and their 
application as a means to detect and control outbreaks and to implement 
interventions to prevent the further spread of disease. Additionally, 
there is a concerted effort to develop and expand regional disease 
surveillance networks that include less developed nations as members.
    CDC has also created two International Emerging Infections Programs 
(IEIPs)--one in Thailand (established in 2001) and one in Kenya 
(scheduled to open in 2003)--that are modeled on the domestic EIP 
Programs described earlier which have been so successful in the United 
States. The IEIPs will help to foster the next generation of 
international public health leaders while providing high quality 
disease surveillance data and rapid response capacity for new and 
emerging diseases.

Conclusion
    CDC is committed to working with federal, state and local partners 
to protect the nation's health. Our best public health strategy against 
disease is the development, organization, and enhancement of public 
health disease detection systems, tools, and the people needed to wield 
them. The astute clinician remains the critical link in disease 
detection and reporting. The first case of West Nile in 1999, and the 
first case of anthrax reported in early October 2001, were identified 
by astute clinicians. Training and education of these front-line health 
protectors remains a high priority for CDC and will continue to be a 
priority as we strive to improve all components of the nation's disease 
detection systems.
    While we have made substantial progress towards enhancing the 
nation's capability to rapidly detect disease within our communities, 
improving our response and containment strategies, and developing plans 
to recover from tragic events, much remains to be done. CDC is very 
grateful for the congressional support received to date and looks 
forward to working with the Members of Congress, especially this 
committee as we strive to protect the public's health from terrorism 
and other public health emergencies.
    Thank you very much for your attention. I will be happy to answer 
any questions you may have.

[GRAPHIC] [TIFF OMITTED] T0168.038

[GRAPHIC] [TIFF OMITTED] T0168.039

[GRAPHIC] [TIFF OMITTED] T0168.040

[GRAPHIC] [TIFF OMITTED] T0168.041

[GRAPHIC] [TIFF OMITTED] T0168.042

[GRAPHIC] [TIFF OMITTED] T0168.043

[GRAPHIC] [TIFF OMITTED] T0168.044

[GRAPHIC] [TIFF OMITTED] T0168.045

[GRAPHIC] [TIFF OMITTED] T0168.046

[GRAPHIC] [TIFF OMITTED] T0168.047

[GRAPHIC] [TIFF OMITTED] T0168.048

    Mr. Shadegg. Thank you, Mr. Henderson.
    Next we will hear from Janet Heinrich, director of public 
health issues at the U.S. General Accounting Office.

   STATEMENT OF MS. JANET HEINRICH, DIRECTOR, PUBLIC HEALTH 
             ISSUES, U.S. GENERAL ACCOUNTING OFFICE

    Ms. Heinrich. Mr. Chairman and members of the subcommittee, 
I appreciate the opportunity to discuss State and local 
preparedness to manage outbreaks of infectious diseases, be 
they naturally occurring or the product of bioterrorism.
    Recent challenges such as the SARS outbreak and the anthrax 
incidents of 2001 have raised concerns about the nation's 
preparedness to manage a disease outbreak or a bioterrorism 
event. Existing surveillance systems have weaknesses such as 
chronic underreporting and outdated laboratory facilities, 
which have raised concerns about the ability of State and local 
agencies to quickly detect infection disease outbreaks.
    My remarks will focus on the preparedness of State and 
local public health agencies for responding to infectious 
disease outbreaks, and the contributions of hospital 
preparedness for such an event. To assess bioterrorism 
preparedness, we conducted visits to seven cities and their 
respective State governments from December 2001 through March 
2002. We are currently reviewing the summer 2003 CDC and HRSA 
applications and progress reports, as well as interviewing 
State and local officials from these jurisdictions, and from a 
few additional States and two major municipalities.
    In order to be prepared for infectious disease outbreaks, 
State and local public health agencies need to have several 
basic capabilities such as disease surveillance systems and 
epidemiologists to detect clusters of suspicious symptoms or 
diseases, laboratories with adequate capacity and staff to test 
clinical and environmental samples, and communications systems 
to easily communicate with other health care providers. 
Hospitals need the necessary capacity to treat infectious 
diseases, and emergency department staff needs to be able to 
recognize and report unusual illness patterns.
    State and local officials for the cities we visited 
recognized and were attempting to address inadequacies in their 
surveillance systems. They were developing systems using 
electronic databases and several cities were evaluating the use 
of non-traditional data sources such as pharmacy sales. 
Officials reported that CDC funds have enabled them to make 
improvements, including the Web-based reporting that we just 
heard about and active surveillance.
    According to preliminary data from our review this year, 
improvements have also been made in the laboratory 
infrastructure, including upgrading facilities, purchasing 
reagents and equipment, and improving capabilities to test for 
select biologic agents. Most of the cities we visited have 
purchased communication systems that allow officers and 
officials from different organizations to communicate with one 
another in an emergency. In addition, they have been working 
with CDC to build their capability with HAN, the Health Alert 
Network, which provides the high-speed Internet connectivity.
    However, workforce shortages continue to be a major 
concern. Officials report concerns about not having enough 
epidemiologists to complete investigations, as well as 
retaining trained laboratory personnel. A continuing concern 
for response organization officials was the lack of planning at 
the regional level. There continues to be a lack of 
coordination between States that would severely hamper a 
response to an infectious disease outbreak.
    Our surveillance capabilities also depend in large part on 
the capabilities of hospitals and trained staff in emergency 
departments. In our survey of over 2,000 metropolitan hospitals 
most hospitals reported training staff in biological agents, 
but fewer than half have participated in drills or exercises 
related to bioterrorism. We also found that most emergency 
departments have experienced some degree of overcrowding, which 
is more pronounced in the largest metropolitan areas and where 
there has been high population growth. Hospital capacity is 
expected to be strained if, for example, there were another 
SARS outbreak during the winter months when you have peak loads 
of patients with influenza.
    In conclusion, efforts at the State and local level have 
improved their ability to identify and respond to infectious 
disease outbreaks and bioterrorism. Despite these improvements, 
gaps in preparedness remain. Some disease surveillance systems 
need to be upgraded. There are shortages of key personnel and 
hospital emergency departments across the country lack capacity 
for managing infectious disease outbreaks.
    Mr. Chairman, that completes my prepared statement. I am 
happy to answer any questions you may have.
    [The statement of Ms. Heinrich follows:]

                 UNITED STATE GENERAL ACCOUNTING OFFICE

                          INFECTIOUS DISEASES

  Gaps Remain in Surveillance Capabilities of State and Local Agencies

  Prepared Statement of Janet Heinrich, Director, Health Care--Public 
                             Health Issues

    Mr. Chairman and Members of the Subcommittee:
    I appreciate the opportunity to be here today to discuss the work 
we have done on state and local preparedness to manage outbreaks of 
infectious diseases, which may be naturally occurring or the product 
ofbioterrorism. In order to be adequately prepared for such a major 
public health threat, state and local public health agencies need to 
have several basic capabilities, including disease surveillance 
systems.\1\ I Surveillance is public health officials' most important 
tool for detecting and monitoring both existing and emerging 
infections. Effective surveillance can facilitate timely action to 
control outbreaks and inform allocation of resources to meet changing 
disease conditions. Without adequate surveillance, local, state, and 
federal officials cannot know the true scope of existing health 
problems and may not recognize new diseases until many people have been 
affected.
---------------------------------------------------------------------------
    \1\ Disease surveillance uses systems that provide for the ongoing 
collection, analysis, and dissemination of health-related data to 
identify, prevent, and control disease.
---------------------------------------------------------------------------
    Recent challenges, such as the SARS \2\ outbreak and the anthrax 
incidents in the fall of 2001, have raised concerns about the nation's 
preparedness to manage a disease outbreak or a bioterrorist event 
should it reach large-scale proportions. Existing surveillance systems 
have weaknesses, such as chronic underreporting and outdated laboratory 
facilities, which raise concerns about the ability of state and local 
agencies to detect emerging diseases or a bioterrorist event. As a 
result, state and local response agencies and organizations have 
recognized the need to strengthen their public health infrastructure 
and capacity. The improvements they are making are intended to 
strengthen their ability to identify and respond to major public health 
threats, including naturally occurring infectious disease outbreaks and 
acts of bioterrorism.
---------------------------------------------------------------------------
    \2\ SARS is the abbreviation for severe acute respiratory syndrome.
---------------------------------------------------------------------------
    To assist the Subcommittee in its consideration of our nation's 
capacity to detect and monitor an outbreak of an infectious disease, my 
remarks today will focus on (1) the preparedness of state and local 
public health agencies for responding to an infectious disease 
outbreak, and (2) the contributions of hospitals to preparedness for an 
infectious disease outbreak.
    My testimony today is based largely on our recent work, including a 
report on state and local preparedness for a bioterrorist attack.\3\ 
For that report, we conducted site visits in December 2001 through 
March 2002 to seven cities and their respective state governments. We 
also reviewed each state's spring 2002 applications for bioterrorism 
preparedness funding to the Department of Health and Human Services' 
(HHS) Centers for Disease Control and Prevention (CDC) and Health 
Resources and Services Administration (HRSA), and each state's fall 
2002 progress report on the use of that funding. In addition, I will 
discuss some preliminary findings trom our current work that provides 
updated information on the preparedness of state and local public 
health agencies. For that work, we are reviewing the summer 2003 
applications and progress reports and interviewing public health 
officials trom 10 states and two major municipalities. I also will 
present some findings from a survey we conducted in 2002 on hospital 
emergency department capacity and emergency preparedness.\4\ We 
conducted our work in accordance with generally accepted government 
auditing standards.
---------------------------------------------------------------------------
    \3\ U.S. General Accounting Office, Bioterrorism: Preparedness 
Varied across State and Local Jurisdictions, GAO-03-373 (Washington, 
D.C.: Apr. 7, 2003).
    \4\ Findings from the survey include those related to emergency 
department capacity, which we reported in U.S. General Accounting 
Office, Hospital Emergency Departments: Crowded Conditions Vary among 
Hospitals and Communities, GAO-03-460 (Washington, D.C.: Mar. 14, 2003) 
and to hospital emergency preparedness for mass casualty incidents, 
which we reported in U.S. General Accounting Office, Hospital 
Preparedness: Most Urban Hospitals Have Emergency Plans but Lack 
Certain Capacities/or Bioterrorism Response, GAO-03-924 (Washington, 
D.C.: Aug.6,2003).
---------------------------------------------------------------------------
    In summary, state and local officials in the cities we visited 
reported varying levels of public health preparedness to respond to 
outbreaks of emerging infectious diseases such as SARS. They recognized 
gaps in preparedness elements that have been difficult to address, 
including the disease surveillance and laboratory systems and the 
response capacity of the workforce. They also were beginning to address 
gaps in preparedness elements such as communication. We found that 
planning for regional coordination was lacking between states.
    Because those with symptoms of an infectious disease might go to 
emergency departments for treatment, hospital personnel would likely be 
some ofthe first healthcare workers with the opportunity to identify an 
infectious disease outbreak. Therefore, the disease surveillance 
capacities of many state and local public health systems may depend, in 
part, on the surveillance capabilities of hospitals. Most hospitals 
reported training their staff and planning coordination efforts with 
other public health entities. However, even with these preparations in 
place, hospitals lacked the capacity to respond to large-scale 
infectious disease outbreaks.
Background
    Infectious diseases include naturally occurring outbreaks, such as 
SARS, as well as diseases from biological agents that are intentionally 
released by a terrorist, such as smallpox.\5\ An infectious disease 
outbreak, either naturally occurring or from an intentional release, 
may not be recognized for a week or more because symptoms may not 
appear for several days after the initial exposure, during which time a 
communicable disease could be spread to those who were not initially 
exposed.
---------------------------------------------------------------------------
    \5\ CDC developed a critical agent list that focuses on the 
biological agents that would have the greatest impact on public health. 
This list includes a category of agents identified by CDC as most 
likely to be used in a bioterrorist attack and includes communicable 
diseases such as smallpox and pneumonic plague.
---------------------------------------------------------------------------
    The initial response to an infectious disease of any type, 
including a bioterrorist attack, is generally a local responsibility 
that could involve multiple jurisdictions in a region, with states 
providing additional support when needed. Figure 1 presents the 
probable series of responses to a covert release of a biological agent. 
Just as in a naturally occurring outbreak, exposed individuals would 
seek out local health care providers, such as private physicians or 
medical staff in hospital emergency departments or public clinics. 
Health care providers would report any illness patterns or diagnostic 
clues that might indicate an unusual infectious disease outbreak 
associated with the intentional release of a biologic agent to their 
state or local health departments.

[GRAPHIC] [TIFF OMITTED] T0168.026

[GRAPHIC] [TIFF OMITTED] T0168.027

    In order to be adequately prepared for emerging infectious 
diseases in the United States, state and local public health agencies 
need to have several basic capabilities, whether they possess them 
directly or have access to them through regional agreements. Public 
health departments need to have disease surveillance systems and 
epidemiologists to detect clusters of suspicious symptoms or diseases 
in order to facilitate early detection of disease and treatment of 
victims. Laboratories need to have adequate capacity and necessary 
staff to test clinical and environmental samples in order to identify 
an agent promptly so that proper treatment can be started and 
infectious diseases prevented from spreading. All organizations 
involved in the response must be able to communicate easily with one 
another as events unfold and critical information is acquired, 
especially in a large-scale infectious disease outbreak.
    In the event of an outbreak, hospitals and their emergency 
departments would be on the front line, and their personnel would take 
on the role of first responders. Because hospital emergency departments 
are open 24 hours a day, 7 days a week, exposed individuals would be 
likely to seek treatment from the medical staff on duty. Staff would 
need to be able to recognize and report any illness patterns or 
diagnostic clues that might indicate an unusual infectious disease 
outbreak to their state or local health department. Hospitals would 
need to have the capacity and staff necessary to treat severely ill 
patients and limit the spread of infectious disease.
    The federal government also has a role in preparedness for and 
response to major public health threats. It becomes involved in 
investigating the cause of the disease, as it is doing with SARS. In 
addition, the federal government provides funding and resources to 
state and local entities to support preparedness and response efforts. 
CDC's Public Health Preparedness and Response for Bioterrorism program 
provided funding through cooperative agreements in fiscal year 2002 
totaling $918 million to states and municipalities to improve 
bioterrorism preparedness and response, as well as other public health 
emergency preparedness activities. The funding supported development 
and improvements in a number of areas CDC considers critical to 
preparedness and response, including surveillance capacity to rapidly 
detect outbreaks of illness that may be the result of bioterrorism or 
other public health threats.
    HRSA's Bioterrorism Hospital Preparedness Program provided funding 
through cooperative agreements in fiscal year 2002 of approximately 
$125 million to states and municipalities to enhance the capacity of 
hospitals and associated health care entities to respond to 
bioterrorist attacks. Earlier this month, HHS announced that 
approximately $870 million and $498 million have been provided for 
fiscal year 2003 through the CDC and HRSA programs, respectively, to 
states and municipalities to continue these efforts.
Despite Improvements, Gaps Remain in Disease Surveillance Capabilities 
of State and Local Public Health Agencies
    In the cities we visited, state and local officials reported 
varying levels of public health preparedness to respond to outbreaks of 
emerging infectious diseases such as SARS. They recognized gaps in 
preparedness elements that have been difficult to address, including 
the disease surveillance and laboratory systems and the response 
capacity of the workforce. They also were beginning to address gaps in 
preparedness elements such as communication. We found that planning for 
regional coordination was lacking between states.

Progress Has Been Made in Elements of Public Health Preparedness, but 
Gaps Remain
    States and local areas had weaknesses in some public health 
preparedness elements, including the disease surveillance and 
laboratory systems and the response capacity of the workforce. Gaps in 
capacity often are not amenable to solution in the short term because 
either they require additional resources or the solution takes time to 
implement. States and local areas were addressing gaps in 
communication.

Surveillance Systems
    State and local officials for the cities we visited in early 2002 
recognized and were attempting to address inadequacies in their 
surveillance systems. Local officials were concerned that their 
surveillance systems were inadequate to detect a bioterrorist event, 
and all of the states we visited were making efforts to improve their 
disease surveillance systems. Six of the cities we visited used a 
passive surveillance system \6\ to detect infectious disease 
outbreaks.\7\ However, passive systems may be inadequate to identify a 
rapidly spreading outbreak in its earliest and most manageable stage 
because, as officials in three states noted, there is chronic 
underreporting and a time lag between diagnosis of a condition and the 
health department's receipt of the report. To improve disease 
surveillance, six of the states and two of the cities we visited were 
developing surveillance systems using electronic databases. Several 
cities were also evaluating the use of nontraditional data sources, 
such as pharmacy sales, to conduct surveillance.\8\ Three of the cities 
we visited were attempting to improve their surveillance capabilities 
by incorporating active surveillance components into their systems. For 
our ongoing work, state and local officials told us that their 
surveillance systems had improved somewhat. The officials reported that 
CDC funds have enabled them make some of these improvements in their 
surveillance systems, including the development of Web-based disease 
reporting and active surveillance systems.
---------------------------------------------------------------------------
    \6\ Passive surveillance systems rely on laboratory and hospital 
staff, physicians, and other relevant sources to take the initiative to 
provide data on illnesses to the health department, where officials 
analyze and interpret the information as it arrives. In contrast, in an 
active disease surveillance system, public health officials contact 
sources, such as laboratories, hospitals, and physicians, to obtain 
information on conditions or diseases in order to identitY cases. 
Active surveillance can provide more complete detection of disease 
patterns than a system that is wholly dependent on voluntary reporting.
    \7\ 0fficials in one city told us that although it had no local 
disease surveillance, its state maintained a passive disease 
surveillance system.
    \8\ This type of active surveillance system in which the public 
health department obtains information tTom such sources as hospitals 
and pharmacies and conducts ongoing analysis of the data to search for 
certain combinations of signs and symptoms, is sometimes referred to as 
a syndromic surveillance system. A senior HHS official stated that 
research examining the usefulness of syndromic surveillance needs to 
continue. See S. Lillibridge, Disease Surveillance, Bioterrorism, and 
Homeland Security, Conference Summary and Proceedings Prepared by the 
Annapolis Center for Science-Based Public Policy (Annapolis, Md.: U.S. 
Medicine Institute for Health Studies, Dec. 4, 2001).

Laboratory Facilities
    Officials from all of the states we visited in early 2002 reported 
problems with their public health laboratory systems and said that they 
needed to be upgraded. All states were planning to purchase the 
equipment necessary for rapidly identifying a biological agent. State 
and local officials in most of the areas that we visited told us that 
the public health laboratory systems in their states were stressed, in 
some cases severely, by the sudden and significant increases in 
workload during the anthrax incidents in the fall of 2001. During these 
incidents, the demand for laboratory testing was significant even in 
states where no anthrax was found and affected the ability of the 
laboratories to perform their routine public health functions. 
Following the incidents, over 70,000 suspected anthrax samples were 
tested in laboratories across the country. According to preliminary 
data from our interviews and review of 2003 progress reports, officials 
reported that CDC funds enabled them to make improvements to their 
laboratory infrastructure, including upgrading their laboratory 
facilities, purchasing reagents and equipment, and improving their 
capability to test for select biologic agents.
    Officials in the states we visited in 2002 were working on other 
solutions to their laboratory problems. States were examining various 
ways to manage peak loads, including entering into agreements with 
other states to provide surge capacity, incorporating clinical 
laboratories into cooperative laboratory systems, and purchasing new 
equipment. One state was working to alleviate its laboratory problems 
by upgrading two local public health laboratories to enable them to 
process samples of more dangerous pathogens and by establishing 
agreements with other states to provide backup capacity. Another state 
reported that it was using the funding from CDC to increase the number 
of pathogens the state laboratory could diagnose. The state also 
reported that it has worked to identify laboratories in adjacent states 
that are capable of being reached within 3 hours over surface roads. In 
addition, all of the states reported that their laboratory response 
plans had been revised to cover reporting and sharing laboratory 
results with local public health and law enforcement agencies.

Workforce
    At the time of our early 2002 site visits, shortages in personnel 
existed in state and local public health departments and laboratories 
and were difficult to remedy. Officials from state and local health 
departments told us that staffing shortages were a major concern. Two 
of the states and cities that we visited were particularly concerned 
that they did not have enough epidemiologists to do the appropriate 
investigations in an emergency. Officials at one state department of 
public health we visited said that the department had lost 
approximately one-third of its staff because of budget cuts over the 
past decade. This department had been attempting to hire more 
epidemiologists. Barriers to finding and hiring epidemiologists 
included noncompetitive salaries and a general shortage of people with 
the necessary skills.
    Workforce capacity issues may also hinder implementation of 
infectious disease control measures. For example, the shortage of 
epidemiologists could grow worse if, in the event of a severe outbreak, 
existing health care workers became infected as a result of their more 
frequent exposure to a contaminated environment or became exhausted 
working longer hours. Workforce shortages could be further exacerbated 
because of the need to conduct contact tracing.\9\ According to World 
Health Organization officials, an individual infected with SARS came in 
contact with, on average, 30 to 40 people in Asian countries--all of 
whom had to be contacted and informed of their possible exposure.
---------------------------------------------------------------------------
    \9\ Contact tracing is the identification and tracking of 
individuals who may have been exposed to a person with a specific 
disease.
---------------------------------------------------------------------------
    During our site visits in early 2002, shortages in laboratory 
personnel were also cited. Officials in one city noted that they had 
difficulty filling and maintaining laboratory positions and that people 
that accepted the positions often left the health department for 
better-paying positions. Increased funding for hiring staff cannot 
necessarily solve these shortages in the near term because for many 
types of laboratory positions there are not enough trained individuals 
in the workforce. According to the Association of Public Health 
Laboratories, training laboratory personnel to provide them with the 
necessary skills will take time and require a strategy for building the 
needed workforce.\10\ For our current work updating these findings, 
many of the state and local officials we interviewed cited shortages in 
trained epidemiologists or laboratory personnel as persistent.
---------------------------------------------------------------------------
    \10\ Association of Public Health Laboratories, ``State Public 
Health Laboratory Bioterrorism Capacity,'' Public Health Laboratory 
Issues in Brief Bioterrorism Capacity (Washington, D.C.: October 2002).
---------------------------------------------------------------------------
    In 2002, state and local officials told us that sustained funding 
would be necessary to address one important need-hiring and retaining 
needed staff. They told us they would be reluctant to hire additional 
staff unless they were confident that the funding would be sustained 
and staff could be retained. These statements are consistent with the 
findings of the Advisory Panel to Assess Domestic Response Capabilities 
for Terrorism Involving Weapons of Mass Destruction, which recommended 
that federal support for state and local public health preparedness and 
infrastructure building be sustained at an annual rate of $1 billion 
for the next 5 years to have a material impact on state and local 
governments' preparedness for a bioterrorist event.\11\ We have noted 
previously that federal, state, and local governments have a shared 
responsibility in preparing for terrorist attacks and other 
disasters.\12\ However, prior to the infusion of federal funds, few 
states were investing in their public health infrastructure.
---------------------------------------------------------------------------
    \11\ Advisory Panel to Assess Domestic Response Capabilities for 
Terrorism Involving Weapons of Mass Destruction, Fourth Annual Report 
to the President and the Congress of the Advisory Panel to Assess 
Domestic Response Capabilities for Terrorism Involving Weapons of Mass 
Destruction (Arlington, Va.: RAND, Dec. 15,2002). The Advisory Panel 
was established to assess federal agency efforts to enhance domestic 
preparedness, the progress of federal training programs for local 
emergency responses, and deficiencies in federal programs for response 
to incidents involving weapons of mass destruction; to recommend 
strategies for ensuring effective coordination of federal agency 
response efforts and for ensuring fully effective local response 
capabilities for weapons of mass destruction incidents; and to assess 
appropriate state and local roles in funding effective local response 
capabilities. The Advisory Panel issues annual reports to the President 
and to the Congress and has submitted four annuals reports to date.
    \12\ See U.S. General Accounting Office, Homeland Security: 
Effective Intergovernmental Coordination Is Key to Success, GAO-02-
1013T (Washington, D.C.: Aug. 23,2002).

Communication
    We found that officials were beginning to address communication 
problems. For example, six of the seven cities we visited in early 2002 
were examining how communication would take place in a public health 
emergency. Many cities had purchased communication systems that allow 
officials from different organizations to communicate with one another 
in real time. In addition, state and local health agencies were working 
with CDC to build the Health Alert Network (RAN), an information and 
communication system. The nationwide RAN program has provided funding 
to establish infrastructure at the local level to improve the 
collection and transmission of information related to public health 
preparedness. Goals of the RAN program include providing high-speed 
Internet connectivity, broadcast capacity for emergency communication, 
and distancelearning infrastructure for training. For our current work, 
our preliminary review of the 2003 progress reports from 12 
jurisdictions shows that 11 reported that over 90 percent of their 
population was covered by HAN.

Some State and Local Contingency Planning Underway, but Regional 
Coordination Is Lacking
    As part of the effort to prepare for a possible outbreak of an 
infectious disease, there is contingency planning at the state and 
local levels. Health departments, for instance, are in the process of 
developing contingency response plans for SARS. The SARS preparations 
have been modeled after a checklist designed for pandemic influenza. To 
facilitate these preparations, the Association of State and Territorial 
Health Officials and the National Association of County and City Health 
Officials, in collaboration with CDC, published a checklist for state 
and local health officials to use in the event of a SARS resurgence. 
The checklist encompasses a broad spectrum of preparedness activities, 
such as legal issues related to isolation and quarantine, strategies 
for communicating information to health care providers, and suggestions 
for ensuring other community partners such as law enforcement and 
school officials are prepared.
    During our 2002 site visits, however, we found that response 
organization officials were concerned about a lack of planning for 
regional coordination between states during an infectious disease 
outbreak. As called for by the guidance for the CDC and HRSA funding, 
all of the states we visited in 2002 organized their planning on the 
basis of regions within their states, assigning local areas to 
particular regions for planning purposes. A concern for response 
organization officials was the lack of planning for regional 
coordination between states. A hospital official in one city we visited 
said that state lines presented a ``real wall'' for planning purposes. 
Hospital officials in one state reported that they had no agreements 
with other states to share physicians. However, one local official 
reported that he had been discussing these issues and had drafted 
mutual aid agreements for hospitals and emergency medical services. 
Public health officials from several states reported developing working 
relationships with officials from other states to provide backup 
laboratory capacity.

Hospital Preparedness Improved, But Limitations in Response Capacity 
Remain
    Because those with symptoms of an infectious disease might go to 
emergency departments for treatment, hospital personnel would likely be 
some of the first health care workers with the opportunity to identiry 
an emerging infectious disease outbreak. Therefore, the disease 
surveillance capacities of many state and local public health systems 
may depend, in part, on the surveillance capabilities of hospitals. 
Most hospitals reported training their staff and planning coordination 
efforts with other public health entities. However, even with these 
preparations in place, hospitals lacked the capacity to respond to 
large-scale infectious disease outbreaks.

Hospitals Provide Vital Disease Surveillance Capacity
    The disease surveillance capacities of many state and local public 
health systems may depend, in part, on the surveillance capabilities of 
hospitals. During the recent SARS outbreak in North America, for 
instance, hospital emergency rooms played an important role in 
identirying those who had the disease. According to hospital officials 
in California and New York, hospital emergency room or other waiting 
room staff routinely used questiomaires to screen incoming patients for 
fever, cough, and travel to a country with active cases of SARS. They 
said that hospitals' signs in various locations generally used by 
incoming patients and visitors also asked individuals to identiry 
themselves to hospital staff if they met these criteria. In Toronto, 
which experienced a much greater prevalence of SARS than the United 
States, everyone entering a hospital was required to answer screening 
questions and to have their temperature checked before they were 
allowed to enter.

Most Hospitals Reported Planning and Training Efforts, but Fewer Than 
Half Have Participated in Drills or Exercises
    In our survey of over 2,000 metropolitan hospitals,\13\ most 
reported that they have provided training to staff on biological 
agents, but fewer than half have participated in drills or exercises 
related to bioterrorism. Most hospitals we surveyed reported providing 
training about identifying and diagnosing symptoms for the six 
biological agents identified by the CDC as most likely to be used in a 
bioterrorist attack. At least 90 percent of hospitals reported 
providing training for two of these agents--smallpox and anthrax-and 
approximately three-fourths of hospitals reported providing training 
about the other four--plague, botulism, tularemia, and hemorrhagic 
fever viruses.
---------------------------------------------------------------------------
    \13\ Between May and September 2002, we surveyed over 2,000 short-
term, nonfederal general medical and surgical hospitals with emergency 
departments located in metropolitan statistical areas. (See U.S. 
General Accounting Office, Hospital Emergency Departments: Crowded 
Conditions Vary among Hospitals and Communities, GAO-03-460 
(Washington, D.C.: Mar. 14,2003) for information on the survey universe 
and development ofthe survey.) For the part of the survey that 
specificaIly addressed hospital preparedness for mass casualty 
incidents, we obtained responses from 1,482 hospitals, a response rate 
of about 73 percent.
---------------------------------------------------------------------------
    Our hospital survey found that 4 out of 5 hospitals reported having 
a written emergency response plan for large-scale infectious disease 
outbreaks. Of the hospitals with emergency response plans, most include 
a description of how to achieve surge capacity for obtaining additional 
pharmaceuticals, other supplies, and staff. In addition, almost all 
hospitals reported participating in community interagency disaster 
preparedness committees.
    At the time of our site visits between December 2001 and March 
2002, we found that hospitals were beginning to coordinate with other 
local response organizations and collaborate with each other in local 
planning efforts. Hospital officials in one city we visited told us 
that until September 11,2001, hospitals were not seen as part of a 
response to a terrorist event but that city officials had come to 
realize that the first responders to a bioterrorism incident could be a 
hospital's medical staff. Officials from the state began to emphasize 
the need for a local approach to hospital preparedness. They said, 
however, that it was difficult to impress the importance of cooperation 
on hospitals because hospitals had not seen themselves as part of a 
local response system. The local government officials were asking them 
to create plans that integrated the city's hospitals and addressed such 
issues as off-site triage of patients and off-site acute care.

Most Emergency Departments Have Experienced Some Degree of Crowding
    Our survey of metropolitan hospitals found that most emergency 
departments have experienced some degree of overcrowding.\14\ Persons 
with symptoms of infectious disease would potentially go to emergency 
departments for treatment, further stressing these facilities. The 
problem of overcrowding is much more pronounced in some hospitals and 
areas than in others. In general, hospitals that reported the most 
problems with crowding were in the largest metropolitan statistical 
areas (MSA) and in the MSAs with high population growth. For example, 
in fiscal year 2001, hospitals in MSAs with populations of 2.5 million 
or more had about 162 hours of diversion (an indicator of 
crowding),\15\ compared with about 9 hours for hospitals in MSAs with 
populations of less than 1 million. Also, the median number of hours of 
diversion in fiscal year 2001 for hospitals in MSAs with a high 
percentage population growth was about five times that for hospitals in 
MSAs with lower percentage population growth.
---------------------------------------------------------------------------
    \14\GAO-03-460.
    \15\ Diversions occur when hospitals request that en route 
ambulances bypass their emergency departments and transport patients 
that would have otherwise been taken to those emergency departments to 
other medical facilities.
---------------------------------------------------------------------------
    Hospitals in the largest MSAs and in MSAs with high population 
growth that have reported crowding in emergency departments may have 
difficulty handling a large influx of patients during a potential 
infectious disease outbreak, especially if this outbreak occurred in 
the winter months when the incidence of influenza is quite high. For 
example, public health officials with whom we spoke said that in the 
event of a large-scale SARS outbreak, entire hospital wards may need to 
be used as separate SARS isolation facilities. Moreover, certain 
hospitals within a community may need to be designated as SARS 
hospitals.

Concluding Observations
    Efforts at the state and local level have improved the ability to 
identify and respond to infectious disease outbreaks and bioterrorism. 
These improvements have included upgrades to laboratory facilities and 
communication systems. Hospitals have also begun planning and training 
efforts to respond to large-scale infectious disease outbreaks. Despite 
these improvements, gaps in preparedness remain. We found that some 
disease surveillance systems may be inadequate, that there are 
shortages of key personnel in some localities, and that some hospital 
emergency departments across the country have experienced some degree 
of overcrowding which could be exacerbated during a disease outbreak.
                Mr. Chairman, this completes my prepared statement. I 
                would be happy to respond to any questions you or other 
                Members of the Subcommittee may have at this time.
Contact and Staff Acknowledgments
    For further information about this testimony, please contact Janet 
Heinrich at (202) 512-7119. Angela Choy, Krister Friday, Martin T. 
Gahart, Gay Hee Lee, and Deborah Miller also made key contributions to 
this statement.

Related GAO Products
                Hospital Preparedness: Most Urban Hospitals Have 
                Emergency Plans but Lack Certain Capacities for 
                Bioterrorism Response. GAO-03-924. Washington, D.C.: 
                August 6,2003.
                Severe Acute Respiratory Syndrome: Established 
                Infectious Disease Control Measures Helped Contain 
                Spread, But a Large-Scale Resurgence May Pose 
                Challenges. GAO-03-1058T. Washington, D.C.: July 30, 
                2003.
                Bioterrorism: Information Technology Strategy Could 
                Strengthen Federal Agencies' Abilities to Respond to 
                Public Health Emergencies. GAO-03-139. Washington, 
                D.C.: May 30, 2003.
                SARS Outbreak: Improvements to Public Health Capacity 
                are Neededfor Responding to Bioterrorism and Emerging 
                Infectious Diseases. GAO-03-769T. Washington, D.C.: May 
                7, 2003.
                Smallpox Vaccination: Implementation of National 
                Program Faces Challenges. GAO-03-578. Washington, D.C.: 
                April 30, 2003.
                Infectious Disease Outbreaks: Bioterrorism Preparedness 
                Efforts Have Improved Public Health Response Capacity, 
                but Gaps Remain. GAO-03-654T. Washington, D.C.: April 
                9,2003.
                Bioterrorism: Preparedness Varied across State and 
                Local Jurisdictions. GAO03-373. Washington, D.C.: April 
                7, 2003.
                Hospital Emergency Departments: Crowded Conditions Vary 
                among Hospitals and Communities. GAO-03-460. 
                Washington, D.C.: March 14, 2003.
                Homeland Security: New Department Could Improve 
                Coordination but Transferring Control of Certain Public 
                Health Programs Raises Concerns. GAO-02-954T. 
                Washington, D.C.: July 16,2002.
                Homeland Security: New Department Could Improve 
                Biomedical R&D Coordination but May Disrupt Dual-
                Purpose Efforts. GAO-02-924T. Washington, D.C.: July 9, 
                2002.
                Homeland Security: New Department Could Improve 
                Coordination but May Complicate Priority Setting. GAO-
                02-893T. Washington, D.C.:
                Homeland Security: New Department Could Improve 
                Coordination but May Complicate Public Health Priority 
                Setting. GAO-02-883T. Washington, D.C.: June 25, 2002.
                Bioterrorism: The Centers for Disease Control and 
                Prevention's Role in Public Health Protection. GAO-02-
                235T. Washington, D.C.: November 15,2001.
                Bioterrorism: Review of Public Health Preparedness 
                Programs. GAO-02-149T. Washington, D.C.: October 
                10,2001.
                Bioterrorism: Public Health and Medical Preparedness. 
                GAO-02-14IT. Washington, D.C.: October 9,2001.
                Bioterrorism: Coordination and Preparedness. GAO-02-
                129T. Washington, D.C.: October 5, 2001.
                Bioterrorism: Federal Research and Preparedness 
                Activities. GAO-01-915. Washington, D.C.: September 
                28,2001.
                West Nile Virus Outbreak: Lessons for Public Health 
                Preparedness. GAO/HEHS-00-180. Washington, D.C.: 
                September 11,2000.
                Combating Terrorism: Need for Comprehensive Threat and 
                Risk Assessments of Chemical and Biological Attacks. 
                GAO/NSIAD-99-163. Washington, D.C.: September 14, 1999.
                Combating Terrorism: Observations on Biological 
                Terrorism and Public Health Initiatives. GAO/T-NSIAD-
                99-112. Washington, D.C.: March 16, 1999.

                           September 24, 2003

                          INFECTIOUS DISEASES

  Gaps Remain in Surveillance Capabilities of State and Local Agencies

        What GAO Found
    The efforts of public health agencies and health care organizations 
to increase their preparedness for infectious disease outbreaks and 
bioterrorism have improved the nation's ability to recognize such 
events. However, gaps remain in state and local disease surveillance 
systems, which are essential to public health efforts to respond to 
disease outbreaks or bioterrorist attacks. Other essential elements of 
preparedness include laboratory facilities, workforce, and 
communication systems. State and local officials report that they are 
addressing gaps in communication systems. However, there are still 
significant workforce shortages in state and local health departments 
and laboratories. GAO also found that while contingency plans are being 
developed at the state and local levels, planning for regional 
coordination for disease outbreaks or bioterrorist events was lacking 
between states.
    The disease surveillance capacities of many state and local pubic 
health systems depend, in part, on the surveillance capabilities of 
hospitals. Whether a disease outbreak occurs naturally or due to the 
intentional release of a harmful biological agent by a terrorist, much 
of the initial response would occur at the local level, particularly at 
hospitals and their emergency departments. Therefore, hospital 
personnel would be some of the first healthcare workers with the 
opportunity to identify an infectious disease outbreak or a 
bioterrorist event. Most hospitals reported training their staff on 
biological agents and planning coordination efforts with public health 
entities; however, preparedness limitations may impact hospitals' 
ability to conduct disease surveillance. In addition, hospitals still 
lack the capacity to respond to large-scale infectious disease 
outbreaks. Also, most emergency departments across the country have 
experienced some degree of overcrowding, which could be exacerbated 
during a disease outbreak or bioterrorist event if persons with 
symptoms go to emergency departments for treatment.

    Mr. Shadegg. Thank you, Ms. Heinrich.
    Next we will hear from Dr. Richard Platt, Chair, Department 
of Ambulatory Care and Prevention, Harvard Pilgrim Health Care. 
Dr. Platt?

 STATEMENT OF DR. RICHARD PLATT, CHAIR OF THE AMBULATORY CARE 
              AND PREVENTION, HARVARD HEALTH PLAN

    Dr. Platt. Thank you, Mr. Chairman and members of the 
committee.
    I should also say that although I am a professor at Harvard 
Medical School, my medical school department is jointly 
sponsored by a health plan, Harvard Pilgrim Health Care. I 
appreciate the opportunity to talk with you today about the 
CDC-sponsored National Bioterrorism Surveillance Demonstration 
Program that my partners and I are undertaking. This is a 
three-way partnership that involves the health plans, the 
public health sector and the academic community.
    The health plans bring to this partnership their rich 
information sources and ability to communicate with large 
numbers of clinicians and their patients. The public health 
sector brings the ability to set priorities and coordinate 
responses. The academic community is contributing its 
information and knowledge and tools.
    This partnership has been active for some time and has been 
working on a number of important health problems, including 
bioterrorism preparedness. My own experience in detecting 
bioterrorism began in 2000 with a grant from the CDC to the 
Massachusetts Department of Public Health. I should point out 
that was before 9-11. We use information from the electronic 
medical records of a large physician group to gather diagnoses 
as soon as they are made, and then we analyze this information 
for evidence of unusual disease activity and we communicate 
that back to our public health colleagues.
    You have handouts at your desk showing an example of the 
kind of information we give to our pubic health colleagues. 
This is a screen shot of our protected Web site showing the 
disease activity in the Greater Boston area yesterday. This 
information became available early this morning. It shows that 
nothing unusual happened yesterday. The way it does that is to 
highlight the five most unusual census tracts in the Greater 
Boston area. In this way, our public health colleagues do not 
have to evaluate a lot of numbers. They have to look at what is 
unusual, and we get to this unusualness by taking into account 
the number of health plan members who live in those census 
tracts and the number of other factors that affect disease 
incidence.

[GRAPHIC] [TIFF OMITTED] T0168.028

    This information provides early warning for both 
bioterrorism and naturally occurring illnesses. The system is 
also flexible enough to add additional purposes that we had not 
originally planned. For instance, soon after we activated this 
system, the State's influenza tracking branch asked us to track 
influenza-like illness and we added that at no cost to the 
system or to our sponsors, and report that on a regular basis 
now. We are currently in discussions about ways that we might 
monitor SARS if it appears in our community.
    I believe that three major elements contribute to the 
success of our program. The first is the availability of 
electronic medical records. They are complete, they are 
available immediately, and the process of obtaining information 
does not require the clinicians to take any additional actions 
beyond the regular care they deliver.
    The second important element was the development of a 
computerized method to identify potential outbreaks. The system 
takes into account historical patterns of illness and allows us 
to recognize unusual numbers of events as early as possible. 
This is important because recognizing an outbreak can be like 
viewing a mosaic while standing very close to it. At least 
initially, the key may be the pattern of cases, rather than the 
features of any individual case, and these patterns can differ 
at different times and in different places, and therefore be 
difficult to recognize early. Using computerized identification 
methods also allows us to provide alerts to public health 
officials so they do not have to examine the actual numbers of 
illnesses each day, especially when there is no special 
concern.
    The third element of our success was the willingness of the 
health plan and the physicians to share their medical record 
information. The major reason for this is that we designed the 
system so that they continue to be the custodians of their 
patients's healthcare data. All that they provide to us is the 
number of new cases of different kinds of illness in each area. 
If we detect a potential cluster, then the health department 
requests information from the health plan about the specific 
cases that contribute to that cluster. We built a mechanism to 
allow them to obtain that additional information very quickly. 
This arrangement corresponds to the health plan's and 
clinician's understanding of their patients's strong desire 
that information about their individual medical visits be kept 
private unless there is an immediate and compelling public 
health need for it.
    During the past year, the CDC has supported our work to 
create a system that uses these principles to integrate 
information from many health plans. Our principal partner in 
this activity is the American Association of Health Plans, 
which represents approximately 1,000 health plans that care for 
over 170 million Americans. Additional participants include 
health plans in Minnesota, Massachusetts, Colorado and Texas, 
and the National Nurse Call Center that cares for individuals 
in all 50 States.
    The information on the second page of your handout shows 
the data flow for this system, with health plans identifying 
new episodes, communicating that to the data center using 
protected Internet technology. The data center uses that count 
information to identify unusual clusters. The information is 
posted on a protected Web site. When there is a cluster, we can 
notify both the health plan and the health department. The 
health plan and the health department then interact with each 
other to further their communication. Although we are still 
creating some parts of this system, our preliminary evidence 
indicates that it does identify outbreaks of public health 
interest.

[GRAPHIC] [TIFF OMITTED] T0168.029

    If you take a look at the third sheet of the handout, 
this is a national map showing the disease incidence in the 
middle of last December. I picked this date because although 
most of the nation, which is colored pink, is showing that 
there is no unusual data, in Massachusetts there is quite an 
impressive spike. It is hard to see on this sheet, but if you 
look at the next page it shows that in Massachusetts you can 
see that there are a number of zip codes in Massachusetts that 
have an unusually high volume of new respiratory illnesses. By 
our calculations, this was a once in 8-year event that lasted 4 
days and involved hundreds of people.

[GRAPHIC] [TIFF OMITTED] T0168.030

    We have several goals for the coming year. First, we 
want to make the transition to a stable, ongoing system. In 
addition, we are in discussion with our colleagues at the CDC 
about ways that we can collaborate with Project BioSense to 
adapt our detection methods to that system and to make the data 
from our health plans available through BioSense. We also want 
to work with CDC to improve health departments's ability to 
communicate quickly and effectively with practicing clinicians 
and the millions of individuals for whom they provide care. We 
also hope to make use of new types of medical information and 
to develop more sophisticated methods for developing disease 
outbreaks at the earliest possible time.
    In summary, we have learned that routinely collected health 
plan data can be an important public health resource and it can 
be used in ways that minimizes patients's privacy concerns. My 
colleagues and I believe that this system can make a valuable 
contribution to the public health system's ability to identify 
and to respond to health threats at the earliest possible 
moment.
    I also believe that our work is even more important as an 
example of the possibilities of the partnerships that we can 
create between the private healthcare delivery system, the 
public health sector, and the academic community. Because of 
this, I believe that this three-way partnership has the 
potential to transform the health of our society if we take the 
proper steps to nurture it.
    Thank you very much.
    [The statement of Dr. Platt follows:]

                  PREPARED STATEMENT OF RICHARD PLATT

    Good afternoon Mr. Chairman and members of the Subcommittee. My 
name is Richard Platt; I am a Professor at Harvard Medical School, 
where I chair the Department of Ambulatory Care and Prevention, a 
department that is unique in being jointly sponsored by a medical 
school and by a health plan, Harvard Pilgrim Health Care. I am also an 
infectious diseases specialist, an epidemiologist, and a member of the 
Board of Scientific Counselors of the Center for Disease Control and 
Prevention's (CDC) National Center for Infectious Diseases.
    I am very excited about this opportunity to discuss our National 
Bioterrorism Surveillance Demonstration Program and the work we do 
daily to detect and respond to both bioterrorism and naturally 
occurring disease outbreaks. The National Demonstration Program is the 
product of an evolving three-way partnership between private health 
plans and physician groups, public health agencies, and the academic 
community. This partnership makes an important contribution to 
protecting the overall health of our nation by combining our unique 
strengths:
 the private health system's information infrastructure and its 
ability to communicate both with clinicians and with the people for 
whom they provide care;
 the public sector's ability to set major health priorities and 
coordinate a response; and
 the academic community's skills in developing the knowledge 
and tools to make the most of these capabilities.
    In addition to the work I will describe today, this three-way 
partnership is currently making important contributions to our ability 
to prevent illness, treat disease, improve the safety of drugs and 
vaccines, and improve the delivery of health care.
    Before I describe our National Demonstration Program, I think it 
will be helpful for you to know how it began. My work on detecting 
bioterrorism began in 2000 when the Massachusetts State Epidemiologist, 
Dr. Alfred DeMaria, and I developed a partnership between the 
Massachusetts Department of Public Health, Harvard Pilgrim Health Care, 
and Harvard Vanguard Medical Associates to enhance early-detection and 
public health communication capabilities. This project was supported by 
a bioterrorism preparedness grant from the CDC to the State of 
Massachusetts. We had three major goals: first to quickly gather the 
diagnoses made in everyday practice by hundreds of physicians in 
eastern Massachusetts; then to analyze this information for evidence of 
unusual disease activity; and finally to create a mechanism for public 
health officials to communicate rapidly with clinicians to follow up 
the outbreak signals we detected. Because of our early start, our 
eastern Massachusetts detection system went ``live'' in October of 
2001, within weeks of the anthrax attack that brought bioterrorism to 
prominence. This system is described in articles in Emerging Infectious 
Diseases (2002 Aug;8(8):753-60) and BMC Public Health (2001;1:9).
    Our system has been active since then, identifying the census 
tracts in our region with the most unusual number of new cases of 
respiratory, gastrointestinal, and several other categories of illness, 
which may indicate potential outbreaks. This information is displayed 
via maps and tables on a secure internet site that is accessible to the 
state health department. The following illustration shows the 
information that public health officials view on a typical day.

[GRAPHIC] [TIFF OMITTED] T0168.031

    An important feature of this display is that it only highlights 
areas with the most unusual number of people who have a new episode of 
illness, after eliminating seasonal and other effects. On the majority 
of days, nothing unusual occurs. However, when we observe an unusually 
large number of cases in a specific locale, a clinician who works in 
the medical practice that provides the information, and who is 
responsible for public health reporting, provides additional 
information to the health department. Fortunately, there have been no 
cases of bioterrorism since our program became active. However, we 
understood from the outset that this information would also serve a 
separate purpose of providing routine, high quality, timely, 
information to the public health department about naturally occurring 
illnesses in these communities--earlier than is possible with 
traditional physician reporting of diagnosed diseases. Using historical 
data from the health plan and state records, we were able to 
demonstrate that office visits for wintertime respiratory illness 
increased about two weeks before an increase in respiratory 
hospitalizations occurred. In addition, we have been able to identify 
unusual clusters of respiratory infections, as shown in the following 
figure, which illustrates a once-in-eight-year cluster involving 
hundreds of people that occurred last December.

[GRAPHIC] [TIFF OMITTED] T0168.032

    Soon after we began providing routine reports to our colleagues 
in the Massachusetts Department of Health, the department's influenza 
tracking branch requested that we report a new disease category--
influenza-like illness-- and we added this feature without any 
additional resources from the clinical system or the state. We are 
currently discussing with CDC ways to adapt this system to detect the 
occurrence of Severe Acute Respiratory Syndrome (SARS) if it appears in 
our region. The Institute of Medicine (10M) described this detection 
system in Massachusetts as an example of the ability of the health care 
delivery system to play an important role in disease detection and 
reporting in its recent report, ``The Future of the Public's Health in 
the 21st Century,'' (page 249).
    Several critical elements contribute to the success of this 
program. The first is the fact that a large physician group, Harvard 
Vanguard Medical Associates, uses electronic medical records to provide 
routine patient care. Therefore, information about diagnoses, symptoms, 
and vital signs is available at the end of each day. Clinicians are not 
required to collect any additional information, to record it in any 
special way, or to take any additional steps to report needed 
information. Thus, we avoid burdening already overloaded clinicians and 
their support staff and we are confident that the clinical information 
is complete. In addition, since we focus on health plan members, we 
also know how many members are not sick. This provides added confidence 
that the detection system will alert us to problems that occur in the 
health plans' enrolled population.
    The second important element was development of a method to 
identify potential outbreaks. We accomplish this using a computerized 
analysis program that takes into account historical patterns of illness 
and allows us to recognize when unusual numbers of events occur. 
Assessing patterns of illness is important because our system looks for 
clusters of individual cases that may not seem unusual to the 
clinicians who are providing care. The absence of distinguishing 
features is often the case for conditions like SARS. It causes severe 
symptoms in only a small fraction of infected people, yet detection of 
the larger number of people who develop mild symptoms and then recover 
may signal the arrival of the virus to an area. Additionally, even 
life-threatening illnesses like anthrax and smallpox typically begin 
with a few days of mild illness that cannot be distinguished in routine 
practice from common illnesses. Even highly experienced epidemiologists 
find it difficult to recognize unusual numbers of illnesses because of 
the difficulty of taking into account multiple factors--the day of the 
week, the season, whether it is the day after a holiday, the history of 
incidence over prior years, and the typical patterns of care in 
specific communities. An unusually high number of ill people on a 
Wednesday in August may be quite ordinary for a Monday in January, and 
a few cases in one community can be much more significant than a much 
larger number in a nearby community. Thus, our cluster detection 
analysis system is a key element in the system's effectiveness.
    An additional reason to use computerized methods to identify 
unusual situations is to provide alerts to public health officials. Our 
public health colleagues have advised us that it is inefficient to 
examine the actual numbers of illnesses each day, especially when there 
is no special concern. In short, our detection system sifts and 
analyzes huge volumes of data and only in rare cases alerts public 
health officials to an unusual signal that requires attention.
    A third important contributor to our success is the willingness of 
the health plan and physicians' practice to share this critical health 
information. One reason health plans and medical groups are willing to 
do this is that we constructed the system so that they continue to be 
custodians of their patients' health care data, providing only the 
information that is needed for tracking the public's health. The only 
information that health plans submit to us is the number of individuals 
in each zip code or census tract with visits for respiratory, 
gastrointestinal, or other types of medical problems. If the number of 
cases is unusually large, the health department requests the 
corresponding visit-by visit information, which is stored at the health 
plan. The health department contacts a designated clinical responder in 
the health plan for any additional information that is needed. The 
clinician responds in a timely manner and has ready access to 
information about the individual and the details of the illness.
    Organizing the system this way is appealing to the health plans and 
the public for two major reasons. First, it corresponds to the public's 
desire for health plans and physicians to keep information about their 
individual medical visits private unless there is a compelling public 
health need for such information. Second, health plans know that visit 
level information can be used for other purposes, such as litigation 
and competitive purposes, and so they want to be as certain as possible 
that the information they provide is accurate and used only for the 
intended purpose--public health. Several health plans have had recent 
experiences in which a public health agency has not been able to assure 
the confidentiality of data that they provided. While many health plans 
believe strongly in contributing actively to our nation's public 
health, they also want to minimize the possibility that doing so will 
breach confidentiality.
    During the past year, we have developed the capacity to integrate 
real-time bioterrorism and disease detection information from many 
health plans. This National Demonstration Program has been supported by 
the CDC through a grant to one of its Prevention Epicenters, which I 
lead. The design of this program has been guided by our work in 
Massachusetts, as well as the considerable experience of health plans 
in Minnesota and Colorado. Our major partner in this work is the 
American Association of Health Plans, which is the principal national 
organization representing more than 1,000 health plans that provide 
coverage for more than 170 million Americans nationwide. Additional 
participants are four health plans or physician groups--Harvard Pilgrim 
Health Care/Harvard Vanguard Medical Associates (Massachusetts), 
HealthPartners (Minnesota), Kaiser Permanente Colorado, and 
UnitedHealthcare's nurse call center, Optum. The coordinating center is 
at Harvard Medical School's Channing Laboratory.
    We also recently began working with three health providers in 
Texas, Scott and White Healthcare System, the Austin Regional Clinic, 
and Austin Diagnostic Clinic, after a local health officer asked us to 
help him develop a disease surveillance system. The health officer 
secured necessary funding from the Texas Association of Local Health 
Organizations to support their participation. All of our health plan 
partners have some form of electronic health information. Detailed 
information about this program has been described in articles in the 
Journal of Urban Health (2003;80 #2, Supplement l:i25-i31) and the 
National Journal (April 19, 2003, p 1238-9).
    We are making excellent progress and are enthusiastic about the 
prospects of this detection program. We have created computer programs 
that allow the health plans to automate the large majority of their 
activities. These programs analyze daily clinical information and group 
together visits with different diagnoses, for instance ``cough'' and 
``bronchitis'', identify new episodes of illness so that repeat visits 
for the same illness are not counted twice, assign the new episodes to 
the zip codes where the patients live, count the number of new episodes 
in each zip code, and then transmit only this summary information 
automatically over a secure internet connection to the coordinating 
center at Harvard. At the coordinating center, we combine the 
information from different health plans and search for unusual patterns 
of illness. The computer programs we have developed for the health 
plans also maintain detailed lists of the clinical information that 
underlies the numbers provided to the coordinating center. These 
detailed lists are kept by the health plan and are immediately 
accessible to the clinical responders when a public health department 
seeks additional information for investigation of a possible outbreak. 
The information flow is shown in the following diagram.

[GRAPHIC] [TIFF OMITTED] T0168.033

    We are currently working with our state and local health 
department partners to evaluate our surveillance system's capabilities 
by comparing the clusters that we identify through health plan data to 
confirmed past outbreaks that health departments have detected through 
their usual method of identification. Our preliminary comparison 
indicates that our system identifies the large majority of recognized 
outbreaks that occurred during the past two years, and it also 
highlights potential clusters that the public health system may not 
have detected.
    We are also developing the ability to notify health departments 
automatically of clusters that they wish to know about, through pagers 
or e-mail. We expect this will be the most efficient method of ensuring 
that needed information is used by public health agencies at the 
earliest possible opportunity. At present, we are waiting for the 
public health departments to provide the specifications for these 
automatic notifications.
    In all of our activities, we try to use definitions and methods 
that are consistent with evolving public health practice, with the goal 
of making our information compatible with other detection and response 
systems, including the ESSENCE system developed by the Department of 
Defense, and the CDC's BioSense initiative. We are currently discussing 
with CDC the contributions we can make to BioSense, both in adapting 
our signal detection methods to the broad range of data types in 
BioSense, and making data from our health plans available to the public 
health community through BioSense. We look forward to working with CDC 
and are certain that a continued public-private partnership provides 
the greatest opportunity for improved homeland security.
    We have just been notified that we will receive funding to continue 
this program beyond its first year. Our goals include making the 
transition from program development and testing to a stable, ongoing 
system and collaborating with BioSense, as described above. We 
especially want to work with CDC to improve public health departments' 
ability to communicate quickly and effectively with the large majority 
of practicing clinicians in this country and with over 170 million 
individuals for whose care the health plans are responsible. We are 
convinced there is important additional work to do in acquiring new 
types of data, for instance emergency room visit information, 
additional information from health plans, and in developing more 
sophisticated mathematical models that will allow us to do a better job 
combining information from different data sources within a single 
health plan (for instance, regular office visits and emergency room 
visits) and aggregate information from several plans that serve a 
single area. We are also talking with other health plans and physician 
groups that are interested in contributing their information to this 
system. We also look forward to working with our public health partners 
to creating a wide array of new uses for health plans' data and their 
ability to communicate with clinicians and the people for whom they 
provide care. We believe the framework we have created will facilitate 
this development.
    In conclusion, I want to thank you again for the opportunity to 
discuss our work with you. My colleagues and I believe this system can 
make a valuable contribution to the public health system's ability to 
identify and respond to bioterrorism and other emerging threats at the 
earliest possible moment and it can be expanded to report health plan 
data nationally. I also believe it is even more important as an example 
of the partnerships we can create between the private health care 
delivery system, the public health sector, and the academic community. 
I believe this three-way partnership has the potential to transform the 
health of our society during the coming years if we take the right 
steps to nurture it.

    Mr. Shadegg. Thank you, Doctor.
    We will next hear from Dr. Jonathan L. Temte, infectious 
disease specialist with the American Academy of Family 
Physicians. Doctor?

STATEMENT OF DR. JONATHAN TEMTE, INFECTIOUS DISEASE SPECIALIST, 
             AMERICAN ACADEMY OF FAMILY PHYSICIANS

    Dr. Temte. On behalf of the 94,000 members of the American 
Academy of Family Physicians, I thank Chairman Shadegg and the 
subcommittee for the opportunity to discuss detection of 
bioterrorism in primary care. As Mrs. Christensen can probably 
attest, family doctors like to talk a lot, but I will try and 
keep my comments within the 5-minute limit.
    My goal today is to leave you with these three main themes. 
First, defense against bioterrorism is dependent upon frontline 
physicians. Second, surveillance is necessary for bioterrorism, 
but it is not sufficient. And third, there is a real and 
growing threat to the integrity of our first line of defense.
    The United States needs frontline primary care physicians. 
Detection of bioterrorism requires that astute clinicians are 
available whenever and wherever a victim first presents for 
medical care. On October 2, 2001, an astute clinician made a 
diagnosis of anthrax. Ten additional cases of inhalational 
anthrax eventually presented to physicians from multiple 
specialties in multiple states. In each case, the correct 
diagnosis was made using usual medical care. In retrospect, no 
additional cases were discovered.
    On May 20, 2003, a 3-year-old girl was brought to her 
primary care physician for evaluation of a bite wound to her 
finger. Within 10 days of the initial visit, the diagnosis of 
an unusual pox virus was made. The CDC confirmed the very first 
case of monkeypox in the Western Hemisphere. This diagnosis was 
made using the physicians and facilities in a town of 19,000 
people in rural Wisconsin.
    In these examples, very rare diseases were detected by 
astute clinicians doing no more than what they were trained to 
do on a day-to-day basis. Will physicians immediately recognize 
illnesses due to bioterrorism? The answer is no. Will the cases 
of bioterrorism be identified through usual medical care? Here 
the answer is yes, if those patients have access to well-
trained and competent physicians.
    Family physicians are widely dispersed across America and 
see patients regardless of age, gender or affected organ 
system. It is estimated that family physicians evaluate and 
manage a total of one billion individual medical problems each 
year in this country, and can put these problems into context 
because we know our patients and their families, and we know 
their communities. Accordingly, in the event of future 
bioterrorism events, the first cases will likely present to 
family physicians and other primary care specialists.
    Surveillance for bioterrorism events is totally necessary, 
but it is not sufficient. For surveillance to be workable, it 
has to be highly sensitive and have extreme timeliness of 
detection. These two properties, however, come at an extremely 
high price. When applied to things that are very, very rare, 
and bioterrorism is rare, surveillance will produce a high rate 
of false positive alarms and rapidly overwhelm everyone 
involved.
    Surveillance of disease trends, on the other hand, can 
enhance the role of the astute clinician. Clinicians are better 
able to evaluate their patients when informed of current trends 
in infectious diseases. Moreover, established communications 
systems between public health and primary care physicians that 
are reliable and relevant can also be used to alert clinicians 
of new and upcoming threats.
    While we are facing some significant threats to our first 
line of defense, primary care in the United States is 
declining. Family physicians deal with an ever-increasing 
number of problems, coupled with less compensation and 
increased regulation. The number of graduating family 
physicians peaked in 2000. More telling, the number of training 
positions filled with U.S. medical school graduates peaked in 
1997 and has been steadily declining ever since.
    The message I would like to leave you with today is this. 
Our nation is blessed with an abundance of well-trained, 
competent and compassionate physicians. If an act of 
bioterrorism occurs again, it is highly likely that an astute 
primary care physician doing what he or she is trained to do, 
will detect the first case and sound the alarm. Moreover, it is 
highly likely that that physician and his or her colleagues 
will not only provide the appropriate treatment to that 
patient, but educate and reassure the other worried patients 
that come in, and reduce the panic and terror that is 
associated with bioterrorism.
    Thank you.
    [The statement of Dr. Temte follows:]

              PREPARED STATEMENT OF DR. JONATHAN L. TEMTE

    It is a great honor and privilege to represent the American Academy 
of Family Physicians and its 94,300 members before the House Select 
Homeland Security Subcommittee on Emergency Preparedness and Response. 
We, along with our colleagues in pediatrics, general internal medicine, 
and other medical specialties represent the first line of defense and 
the cornerstone of defense against bioterrorism. We are primary care 
physicians-or a term that I tend to prefer--comprehensive care 
physicians.
    I sit before you today to provide the viewpoint of a practicing 
family physician on the primary care physician's role in the detection 
and response to bioterrorism.

Biodefense in Medical Practice
    Much of today's real biodefense dates back to 1910--the year that 
the Flexner Report was published. This report set into motion a system-
wide revolution in American medicine. It called for standardization in 
medical education. Out of the recommendations of the Flexner Report 
came what we expect and demand today from our physicians: comprehensive 
and competent medical care. Through the review and accreditation of our 
four-year medical schools and through the review and accreditation of 
our post-graduate residency training programs, the American medical 
system has yielded a wonderful fruit, and that is the realized 
expectation that medical care is relatively stable across geographic, 
economic, ethnic and cultural divisions.
    That is not to say that disparities do not exist. We all know they 
do. Nevertheless, I have the greatest confidence that were I to slump 
over with chest pain here before you and were whisked off to a local 
medical center, I would receive care similar to that which I would 
receive at home.
    Physicians are trained to interact with people, and once one 
interacts with people, one faces uncertainty. Medical practice consists 
of equal parts of science and art. We face uncertainty on a daily basis 
and are trained to take the complaints and concerns placed before us 
and make good choices regarding advice and treatment. The core product 
of an encounter with a patient is the differential diagnosis--that set 
of diagnostic possibilities that could explain our patient's symptoms 
and findings. For example, in the case of inhalational anthrax, we have 
shown that family physicians identify no less than 35 separate and 
distinct diagnostic categories based on the initial presentation of 
this disease. Once set, our job is to narrow the diagnosis using clues 
from our experience, physical examination, the progression of the 
disorder, laboratory tests, radiographs and other technological tools. 
Across the nation, physicians approach similar problems in similar 
ways. The first line of defense against bioterrorism, therefore, is 
nothing more than the comprehensive, competent, complete and 
compassionate application of medical knowledge, skill and experience. 
This has been a given since 1910. Let me provide two examples:
    On October 2, 2001, an incoherent, 63-year-old man with a fever 
presented to a Florida emergency room. Meningitis was a possible 
diagnosis, and later that day he underwent a spinal tap. An infectious 
disease specialist examined the resulting fluid, and noted unusual-
appearing bacteria. A diagnosis of anthrax was first entertained. 
Within two days, the Florida Department of Health Laboratory had 
confirmed anthrax and CDC investigators were conducting epidemiological 
investigations. On October 5, at the invitation of the American Academy 
of Family Physicians, I provided a one-hour lecture about agents of 
biological terrorism to an audience of 2,500 family physicians at the 
Annual Scientific Assembly. Information flowed nearly instantaneously 
onto the Academy's website. In various fashions, similar information 
flowed out to physicians from all specialties across America. This same 
day, the patient died. By the following day--October 6--an autopsy 
confirmed a diagnosis of inhalational anthrax. . . and the dawn of 
modem bioterrorism.
    Within the course of four days, the cause of a patient's illness 
was fully diagnosed, an epidemiological investigation initiated, and 
information disseminated to thousands of practicing physicians. This 
rapid identification occurred even though the last case of inhalational 
anthrax in the United States occurred 23 years previously.
    Eleven cases of inhalational anthrax eventually presented over wide 
expanses of space and time, and to physicians from multiple 
specialties; yet all cases were rapidly diagnosed and appropriately 
treated. Despite widespread post-event assessments of unexpected 
deaths, no additional cases of inhalational anthrax were found.
    On May 13,2003, a three-year-old girl was bitten on her finger by a 
pet prairie dog. One week later she was seen by her primary care 
physician and was treated with antibiotics. Due to her worsening 
condition and a rash, she was hospitalized two days later. On May 25, a 
dermatologist was asked to see the girl. Biopsies showed 
characteristics of a viral infection. On May 27, her mother developed a 
similar rash and skin samples were taken for electron microscopy and 
other testing. On May 30, the illness was shown to be due to a pox 
virus and further testing was performed at the CDC. By June 12, CDC had 
released a fact sheet on this disease. This was the first known case of 
Monkeypox in the Western Hemisphere. It was diagnosed using the medical 
facilities found in a small town of 19,000 people in rural Wisconsin.
    In the fall of2001 and in the summer of2003, something right 
happened and that something was found within the usual responses of 
dedicated medical personnel. This is the legacy of Abraham Flexner.
    In both of these episodes, rare diseases, with which there was no 
previous experience, were identified by astute clinicians who did no 
more than what physicians are trained to do on a day-to-day basis. We 
start with undifferentiated symptoms and stories, use our training and 
experience to consider the possibilities, exclude some diagnoses 
through physical examination, the appropriate use of laboratory and 
other testing and, sometimes, the passage of time. We narrow the 
diagnosis. At each step, we depend on the context of our interactions 
and our knowledge of our patients and their families.
    The members of the American Academy of Family Physicians see 
patients regardless of age, gender or affected organ system. We provide 
care in America's urban areas and rural areas. In many rural areas, we 
may be the only physicians that staff the emergency room, deliver 
babies and operate on patients. We provide a great deal of care to the 
indigent, the underserved and others left behind by our medical care 
system. Without family physicians, 1332 of this nation's 3082 
counties--or 43 percent--would become Primary Care Health Personnel 
Shortage Areas, joining the 25 percent of counties that already are 
underserved.

    Surveillance
    Disease surveillance and detection ultimately depend on the 
patient-physician interaction. It is from this interaction that the 
core ingredients of surveillance emerge. They may take the form of 
individual patients matching a set of criteria, and those patients 
being reported to a public health agency--known as sentinel 
surveillance. They may be the one or two diagnostic codes that are 
assigned to describe the entire interaction for billing purposes--often 
used for mechanistic or electronic syndromic surveillance. They may be 
in the form of the diagnostic tests that are ordered at an encounter, 
forming the basis for laboratory surveillance.
    Sentinel surveillance uses the human element to identify 
individuals in the population fitting a set of characteristics. It can 
be accurate and timely, but is limited by multiple demands placed on 
the sentinels. Nevertheless, approximately 1,600 family physicians 
currently participate in the U.S. Influenza Sentinel Provider 
Surveillance Network, a nationwide program for influenza surveillance 
run by the Influenza Branch of the CDC.
    Mechanistic surveillance makes use of already collected data such 
as billing codes, pharmacy sales, hospital admission diagnoses, or 
other creative entities to rapidly identify changing patterns of 
disease or utilization. Data quality, the knowledge of underlying 
processes, and the reasonability of extrapolations limit mechanistic 
surveillance.
    Laboratory surveillance provides the highest quality data, often 
using ``gold standard'' tests. It is limited by time delays, costs and 
lack of sensitivity.
    All these forms of surveillance are useful and vital in an age of 
emerging microbial threats. The differing methods are complimentary. In 
the context of biological terrorism, however, they are all cursed with 
a fatal flaw. Biological terrorism demands extreme timeliness and high 
sensitivity. When surveillance tools with these characteristics are 
applied to extremely rare conditions, as is inherent in biological 
terrorism, they will produce false alarms at extremely high rates.
    False alarms are costly in terms of the subsequent epidemiological 
investigations, the potential to create fear and panic, and the 
tendency for habituation--that is, learning to ignore the alarms.
    The greatest role played by physicians following the anthrax 
release of 2001 was not treating cases of anthrax, but, rather, dealing 
with the fear and panic of their patients. Allison McGeer--from one of 
the Toronto hospitals affected by SARS--recently noted that it was 
``easier to control the disease than fear.'' In the face of biological 
terrorism, the reassurance of a trusted doctor is invaluable.
    What, then, is the most compelling role of surveillance in 
biodefense? I must reiterate that surveillance is essential and of 
utmost importance for homeland security. Surveillance must first have 
multiple use functions. For biological terrorism and other rare events 
of public health, the primary role of surveillance is to set the 
background against which unusual clinical events can be evaluated. A 
well-informed astute clinician is better than an astute clinician.
    Family physicians are at the core of biodefense by nature of their 
widespread location, their permeation into rural and urban areas, the 
scope of practice-from outpatient setting, to emergency rooms to 
intensive care units-and by the volume of care offered to the American 
populace. On average, family physicians see 90.7 patients per week in 
outpatient settings and deal with an average of 3.05 problems per 
patient encounter. Given the number of active family physicians, one 
can estimate that family physicians may deal with well over one billion 
separate medical problems each year in the United States.
    When this number of problems is coupled with the contextual nature 
of primary care relationships, and if background information can be 
provided to clinicians on community trends in disease occurrence 
through surveillance systems, the value of the astute clinician is 
greatly enhanced. This is the core of rare disease detection and of 
biodefense. In addition to the continued support of primary care 
physicians, three additional components are necessary for biodefense:
        (1) an understanding of the role and function of the public 
        health system.
        There must be a core component of public health practice and 
        epidemiology within medical school curriculum and residency 
        training.
        (2) connectivity of clinicians to sources of information on 
        emerging threats that are rapid, redundant, reliable and 
        relevant.
        (3) easy and rapid means by which unusual cases and 
        presentations can be reported to public health personnel.
    The ability of clinicians to fill the role of the astute clinician 
is hampered by ever increasing demands of the medical care system. 
Primary care physicians have less and less time to fully evaluate 
patient concerns, faced with ever-increasing demands of workload and 
paperwork, regulations and managed care organization compliance.
    We are facing a decline in the number of clinicians choosing to 
practice in the primary care fields. The number of positions for family 
practice residents peaked in 1998; the number of graduating family 
practice residents peaked in 2000. Because of the increasing costs 
associated with medical school training and due to decreasing 
reimbursement for the work that primary care physicians routinely do, 
an increasing number of medical students are choosing other nonprimary 
care medical specialties. National biodefense is dependent on a core of 
well-trained and widely dispersed primary care physicians.
    The current medical system in America is strong and has shown its 
effectiveness in identifying and responding to rare emerging diseases. 
It is essential, however, to acknowledge the key role played in the 
defense against a new world of emerging pathogens by the thousands of 
primary care physicians that dedicate their efforts to the health and 
well-being of their patients and their communities.
    I thank you for the opportunity to address the Subcommittee on 
Emergency Preparedness and Response and thank the Honorable John 
Shadegg for his invitation to provide this testimony.

    Mr. Shadegg. Thank you very much for your testimony.
    Our final witness is Dr. Jeffrey Trent, president and 
scientific director of the Translational Genomics Research 
Institute. Dr. Trent?

STATEMENT OF MR. JEFFREY TRENT, PRESIDENT OF THE TRANSLATIONAL 
GENOMICS RESEARCH INSTITUTE AND FORMER DIRECTOR, NATIONAL HUMAN 
                   GENOME RESEARCH INSTITUTE

    Mr. Trent. Good afternoon, Mr. Chairman and members of the 
committee. Thank you for this opportunity to present.
    My name is Dr. Jeffrey Trent and I am the president and 
scientific director of the Translational Genomics Research 
Institute in Phoenix. Prior to my move to Arizona 8 months ago, 
I served for nearly a decade as the scientific director of the 
Division of Intramural Research for the National Human Genome 
Research Institute at the National Institutes of Health in 
Bethesda. I am accompanied by Dr. Paul Keim of Northern Arizona 
University, one of the foremost experts in the forensic 
analysis of pathogens, and Dr. Paul Tracy of Stanford Research 
Institute.
    I have been asked to speak briefly on the dangers posed by 
a biological outbreak and the need for comprehensive end-to-end 
solutions to these events. I would like to emphasize several 
points for your consideration.
    First, if history repeats itself we will be presented at 
the time of a bio-threat crisis with sick and dying people or 
animals, and the answer will lie in how quickly we can detect 
and identify these early cases. During the training of 
physicians, you are often reminded that if you hear hoof beats 
behind you, look for a horse and not a zebra. But to some 
extent, this logic is reversed in bio-threat identification. 
That is, it is important to develop new approaches and 
diagnostic tests that might reliably separate a bio-threat from 
a new pathogen from the background of the common cold or flu 
which may cause similar symptoms. We believe that one 
possibility for this is reading the signature of the pathogen 
in the host as a critical feature.
    Mr. Chairman, for nearly 20 years I have worked to create 
and utilize tools, many from the human genome project, to 
identify the genetic signature of killers. I have worked on 
killers such as breast cancer, leukemia and melanoma. I had the 
privilege at the National Institute of Health of also working 
to identify the genetic signatures or molecular fingerprints of 
killer viruses such as HIV, various T-cell leukemia viruses, 
and in collaboration with investigators at Fort Dietrich, being 
able to expose cells from individuals with the dreaded ebola 
virus at different virulence to look at those effects. We 
believe that molecular signatures of either naturally infecting 
viruses or bio-weaponized strains can be identified by 
surveying a response in the host.
    So I can emphasize one critical element today, and that is 
that early detection is the key. The reason that early 
detection is the key is that it will mean faster diagnosis and 
faster diagnosis will save lives, optimize treatment selection, 
enable rapid triage of at-risk population, and as we have just 
heard, will provide the vital goal of reassuring the worried-
well and reduce public panic. To achieve this goal, we believe 
there are three major elements that in a systems approach must 
be put in place: 1) the molecular signature that I have spoken 
of previously; 2) very low-cost diagnostic platforms that can 
work in a variety of clinical settings and including of course 
the comprehensive care physicians; 3) a national information 
architecture that allows incident progression and containment 
action to be monitored and provided to relevant key 
decisionmakers within the medical and public health community 
and decision support systems.
    This powerful end-to-end solution is really an obligate 
demand for also including, as we have also heard today in 
testimony, public-private partnerships in the solution to this. 
It really requires that effort. In that regard, I have joined 
my colleagues Dr. George Poste and Paul Keim, as well as 
members from Amersham Biosciences and Stanford Research 
Institute in trying to develop one of the types of end-to-end 
solutions, something we call Project Zebra, as one of the 
solutions for such a complex problem, to allow faster 
mobilization of incident management as one piece in our early 
detection network.
    In closing, I would like to thank you, Mr. Chairman, for 
convening this hearing on an extremely critical subject matter, 
and offering the opportunity to testify before your 
distinguished subcommittee.
    Thank you.
    [The statement of Mr. Trent follows:]

                PREPARED STATEMENT OF DR. JEFFREY TRENT

    Good morning, Mr. Chairman and Members of this subcommittee. My 
name is Dr. Jeffrey Trent, and I am the President and Scientific 
Director of the Translational Genomics Research Institute in Phoenix, 
Arizona. Prior to my move to Arizona 8 months ago, I served for nearly 
a decade as the Scientific Director of the Division of Intramural 
Research of the National Human Genome Research Institute of the 
National Institutes of Health in Bethesda, MD. I also wish to thank the 
members of the Subcommittee on Emergency Preparedness & Response of the 
House Select Committee on Homeland Security and Chairman, John Shadegg 
for inviting us to testify at this hearing today.
    I have been invited here today to speak briefly on the dangers 
posed by a biological outbreak and the need for a comprehensive and 
effective end-to-end solution. I commend you for your willingness to 
hear from representatives of the medical and scientific community about 
this serious and important issue. Both my colleague Paul Keim, and I 
represent many who are ready to work toward addressing shortcomings of 
our early detection and treatment capabilities.
    Mr. Chairman, I would like to emphasize several points for your 
consideration.
    First, history tells us that pre-exposure detection is not 
feasible--we will be presented at the time of a bio-threat crisis with 
sick and dying people or animals, and the answer will lie in how 
quickly we can detect and identify these early cases.
    Also, the answer will lie in new approaches to diagnostic tests 
that can reliably separate bio-threats of new pathogens (such as SARS) 
from the background of the common cold/flu which may cause similar 
symptoms--thus "reading the signature" of the pathogen in the host is 
critical. Joshua Lederberg,\1\ a Nobel Laureate once said: ``The single 
biggest threat to man's continued dominance on the planet is the 
virus.'' With the September 11 terrorist attack and subsequent anthrax 
attacks, what was once a topic popularized for science fiction is now a 
startling reality for all of us.
---------------------------------------------------------------------------
    \1\ Dr. Lederberg is known for his studies of the genetic 
mechanisms of bacteria. He shared with G.W. Beadle and E.L. Tatum the 
1958 Nobel Prize in Physiology or Medicine for establishing that sexual 
recombination occurs in bacteria. Lederberg showed that although 
bacteria reproduce only by dividing, they are able to affect sexual 
recombination by processes that result in exchange of genetic material 
between different bacteria. In 1978, he joined Rockefeller Univ.; where 
he served as president until 1990.
---------------------------------------------------------------------------
    Mr. Chairman for nearly 20 years I have worked to create and 
utilize tools and techniques to identify the genetic signature of 
killers. I have worked on killers such as breast cancer, leukemia and 
malignant melanoma. While at the NIH I also worked on identifying the 
genetic signatures--the molecular fingerprint--of killer viruses such 
as HIV, human T-Iymphotropic virus type 1 (HTLV-1), human herpesvirus 8 
(kaposi's sarcoma-associated herpesvirus), and in collaboration with 
investigators at Ft. Dietrich, the dreaded Ebola virus. We know now 
that a molecular signature of a naturally infecting virus, or a 
bioweaponized strain of anthrax--can be identified by surveying the 
response in the host.
    But, while there is hope that we may be able to identify by 
diagnostic testing a biothreat's genetic signature--the most important 
thing I can emphasize today is that an end-to-end solution is critical, 
and that early detection is the key. Mr. Chairman and Committee 
Members, the reason that early detection is the key is that it will 
mean faster diagnosis--and faster diagnosis will:
 Save lives
 Optimize treatment selection, and
 Enable the rapid triage of at risk populations
(which will provide the vital goal of reassurance to the worried well 
(thereby reducing the risk of public panic).
    To achieve this goal of early detection four elements must be in 
place: and as this is a systems-based approach to the problem, the 
failure to develop anyone of the four will not address the critical 
needs in biodefense and improved public health and safety.
                 Molecular Signatures (BIOPRINT): Gene and 
                protein sequencing of selected pathogens; detection of 
                genomic, proteomic, and phenotypicsignatures of the 
                host immune response, and the creation of unique marks 
                for a broad range of biothreat.
                 Diagnostic Platform (ZPD): Incorporating the 
                signatures into a low-cost diagnostic platform suitable 
                for routine patient testing in a variety of clinical 
                settings.
                 National Information Architecture (Bioincident 
                Warning and Communications System--BWACS). Integrated 
                collection of data, syndromic surveillance, reliable 
                anomaly detection, and real-time alerting of local and 
                national decision-makers that a bioincident has 
                occurred and permit real-time assessment of incident 
                progression and the effectiveness of containment 
                actions. And,
                 Decision Support Systems--An infrastructure 
                linking key decision-makers with relevant medical and 
                public health authorities to ensure rapid launch of 
                optimum treatment protocols, rational allocation of 
                drugs and vaccines, and comprehensive incident 
                containment actions.
    Mr. Chairman and Members of the Subcommittee, currently, health 
providers do not have the necessary tools to distinguish between an 
infection caused by a bio attack and .that caused by the average cold. 
They must rely on a series of sequential, inefficient and cumbersome 
actions that delay mobilization of prompt responses.
    The requirement I believe is the pursuit of a purposeful end-to-end 
solution of all four of the aforementioned system elements--something 
that will require an obligate demand for public/private partnerships.
    This is what has driven me to join my colleagues, Dr. George Poste 
and Dr. Paul Keirn, in a consortium involving the three universities in 
Arizona, linked with Dr. Michael Tracy and his team at the Stanford 
Research Institute, International in Menlo Park, California, with the 
involvement of one of the leading manufacturers of chip-based 
technologies, Amersham Biosciences, in New Jersey, in the development 
of a project called the Project Zebra, which can be part of the 
solution for this complex problem, allowing faster mobilization of all 
relevant incident management actions, a key piece in early detection.
    In closing, I would like to thank you, Mr. Chairman, for convening 
this hearing on an extremely critical subject matter and offering me 
the opportunity to testify before your distinguished subcommittee.

    Mr. Shadegg. Thank you, Doctor.
    I appreciate the testimony of all of our witnesses.
    Before we begin our questioning, Dr. Trent I understand 
that you would like to have Dr. Paul Keim, who is an expert in 
anthrax and plague, join you and complement you in answering 
any questions. Is that correct?
    Mr. Trent. Yes, sir.
    Mr. Shadegg. Dr. Keim, welcome. Would you state and spell 
your name for the record please?
    Mr. Keim. My name is Paul Keim. The last name is spelled
K-E-I-M. I am the Cowden Endowed Chair in Microbiology at 
Northern Arizona University and the director of pathogen 
genomics at T-Gen.
    Mr. Shadegg. Thank you and welcome.
    Let me begin the questioning. Mr. Henderson, let me begin 
with you. You made a reference to BioWatch in your testimony. 
BioWatch intrigues me. It is something I believe could go a 
long ways toward protecting the American public. I would like 
you to tell me about your work with the Department of Homeland 
Security on the BioWatch Program, and how the investment in 
disease surveillance fits into that equation.
    Mr. Henderson. The BioWatch Program is a program that is a 
collaboration. It is being led by the Department of Homeland 
Security and CDC and the Department of Health and Human 
Services are supporting the concept of BioWatch. Fundamentally, 
what it is and how it works is there are a number of air 
samplers placed in participating cities. This is right now a 
proof of concept. We want to make sure it works and contributes 
to the overall detection system in a particular community.
    Staff from the public health laboratories will on a routine 
basis collect the filters in these air samples that are placed 
in strategic locations, subways et cetera, and they will run 
tests across those filters to see if they detect any type of 
pathogen. If they do in fact detect a pathogen, then there are 
consequence management plans in place to execute or mobilize a 
response to determine who may have been exposed, if there is 
still agent in the atmosphere, et cetera.
    Again, this is a proof-of-concept phase. It is taking place 
in a number of cities. We are trying to build systems to assure 
that once we have true positives, we can mobilize a response 
rapidly, but also develop a system for false positives which we 
feel could be a potential problem in the future.
    Mr. Shadegg. I understand this is an airborne detection 
system.
    Mr. Henderson. Right.
    Mr. Shadegg. Is there thought being given to other types of 
detection systems, for example, in a water system?
    Mr. Henderson. We have had discussions, but we have not yet 
developed a program to begin monitoring water.
    Mr. Shadegg. Okay.
    Dr. Trent, Project Zebra. It seems to me this holds 
tremendous potential. I would be interested in how genomics 
links into Project Zebra and how realistic it is. Maybe you 
should describe Project Zebra in a little greater detail and 
how realistic the concept is in terms of creating a device 
which could be used even in an individual doctor's office to 
detect bioterror attack.
    Mr. Trent. Sir, clearly as one piece of the puzzle, we just 
heard environmental sensors are important, but we do think that 
biomedical sensors are equally important. The focus on people 
is as important as the focus on the environment. What we 
strongly believe is as you have heard for the distribution 
system of information within the health sector, that many of 
the available components that we have today for recognizing the 
signatures of pathogens and the type of hardware and software 
that is needed for a comprehensive program is in fact in place 
and capable. I think that my colleagues, Dr. Keim might have 
also have a comment in regard to that, with your permission.
    Mr. Shadegg. Certainly.
    Mr. Keim. So how I can address that question best is based 
upon our experience in the anthrax letter attacks. It may sound 
crazy, but in fact we were better prepared for an anthrax 
attack than any other pathogen, which is scary to think about. 
We had very highly developed genomic analysis already in place. 
In fact, we had analyzed the type of anthrax and knew probably 
where it came from before the first victim died in Florida. 
That type of very early-on information is really a type of 
genomic signature which gives you the information that in fact 
this was a bioterrorist attack.
    There were in fact many naysayers in those first few days 
that did not think that this was a bioterrorism attack, but the 
identity of the strain and its probable source from a U.S. 
laboratory put all that to rest. So Project Zebra is in fact an 
information enhancement upon the current type of diagnostics 
that we have. The more information we can get and the earlier-
on that we can get it about any type of disease, but in 
particular in this case bio-threat pathogens, is just going to 
lead us to better treatment and better response modalities.
    Mr. Shadegg. You indicate that we already had the signature 
on hand for anthrax. Are we developing those signatures for all 
of the other pathogens that might present?
    Mr. Keim. Absolutely, Chairman. We have been funded by the 
Department of Homeland Security and its predecessors for nearly 
a decade to do that. We are developing these signatures to work 
in the framework of BioWatch so that we can get the information 
such as I described from the very first moments of the 
detection process.
    Mr. Shadegg. Dr. Temte, there was an article which appeared 
in the September-October issue of Health Affairs which surveyed 
a number of physicians across America and found that only 20 
percent of physicians felt well-prepared to play a role in 
handling a bioterrorist event. My first question is, do you 
think that is an accurate result? Second, why is that the 
situation and what can be done about it?
    Dr. Temte. Very good questions, Mr. Chairman. I would agree 
that that is probably a good estimate of the current state of 
affairs. We ran a focus group of family physicians prior to the 
anthrax events in March 2001. At that point in time, people 
said we would not recognize any of the classic signs or 
symptoms of anthrax and we are not prepared. We had the 
opportunity to repeat that in March 2002. The big change was 
that everybody said yes, we know the basic diagnostic pattern 
of anthrax. We will recognize the chest x-rays and so on. We 
are still not prepared. We do not know what to do with 
preparedness planning.
    So I think in the big picture, physicians in general have 
very little training, very little information on what to do if 
there are mass casualties, if there is mass panic. Whereas 
hospitals are required for accreditation to have emergency 
preparedness drills, most physicians do not participate. Most 
physicians are not hospital-based, but are clinic-based, and 
there is no incentive. To be honest with you, for most 
physicians there is no time to take out of a very packed 
schedule and participate in a half-day training exercise.
    Mr. Shadegg. Thank you very much.
    Mr. Thompson for questions?
    Mr. Thompson. Thank you very much, Mr. Chairman.
    Let me compliment the panelists on your presentations. Dr. 
Keim?
    Mr. Keim. Yes, sir.
    Mr. Thompson. For someone who might not be as up on 
pathogens as you would think, how many have we identified?
    Mr. Keim. How many different types of anthrax?
    Mr. Thompson. Yes.
    Mr. Keim. In my laboratory, that is in fact exactly what we 
do. We have developed highly precise genomic analysis for 
identifying anthrax. We currently have a database that has 
about 450 unique types of bacillus anthracis or anthrax. That 
is based upon the world's largest collection of strains that 
exist anywhere in the world, right there in Arizona. So we have 
about 450. So in those early hours, we were able to zero in and 
say this strain that came from the victim in Florida belongs to 
this particular category, and that category has only been found 
in nature once. I can tell you exactly where in Texas that 
strain came from. I can tell you what cow it died from, and I 
can tell you its pathway up until it got to the U.S. Army. 
After that, I cannot tell you.
    Mr. Thompson. Thank you.
    Mr. Temte, what do you think we need to do to get 
physicians brought up to the level that you would feel 
comfortable in having them identify some of the problems we are 
talking about?
    Dr. Temte. In a roundabout way, a concern I have is the 
direction that American medical practice took in diverging from 
public health practice approximately 100 years ago. These two 
practices, where as they have a lot of the same purpose and a 
lot of the same goals, operate fairly parallel. The amount of 
interaction has been far too little, especially I think we have 
seen that in the last decade or so.
    That being said, in standard medical training quite often 
any approach to understanding epidemics, understanding the role 
of community, understanding some of these trends that occur 
beyond the level of the individual receive fairly short shrift. 
I think what is necessary is for us to incorporate into not 
only medical school training, but into residency training and 
into practice the means by which we better interact with public 
health.
    Once someone gets into practice, one of the things that you 
find is quite often it is very difficult to establish any 
communication with public health. There was a mention of 
physicians being poor about turning in forms for reportable 
illnesses. I think if you polled most doctors out there, we 
would not know which ones were reportable or not. Why is that? 
Time and priorities. It is very difficult to sort out 
priorities in a busy practice. I have an HMO telling me all the 
guidelines I am not addressing with these certain patients. I 
have my HIPPA compliance. I have to think is this a disclosure 
or not. I have billing things. I have the ICD-9 codes which I 
have to pick from a list so someone knows that diagnosis I am 
making. All these things compete. So when it comes down to 
trying to communicate with public health and find that the 
person is not at the other end of the line, I get an answering 
machine or someone that is not there, it gets to be very, very 
difficult.
    I think systems by which we can improve communication, and 
this has to be a two-way flow of information coming from 
clinicians to public health, to inform public health what is 
going on, but also the flow back to clinicians on a day-to-day 
basis about what is happening out there in the community. Are 
we in the middle of a flu outbreak? If that is, that really 
helps me address the concerns and the problems my patients are 
dealing with.
    So we have to build better communication and be cognizant 
that communication systems need to be very succinct, very 
clinically relevant for clinicians. They have to be redundant 
and very reliable.
    Mr. Thompson. Thank you.
    One other question, Mr. Chairman. Dr. Platt, taking what 
you just heard and applying it to your operation, have you been 
able to streamline that? Have you been able to get the 
reporting faster? I would also like to know if you do, to what 
extent or what percentage of the country is using electronic 
medical records these days, or whether we are still doing it by 
hand?
    Dr. Platt. Really, you have put your finger on both the 
problems and the solutions, I think. In the systems where we 
are working, many of the problems that Dr. Temte mentioned are 
somewhat ameliorated. Stepping back a bit, I believe that our 
nation has been building a very powerful adjunct to the 
traditional public health system in the form of health plans. 
They know all the people for whom they are responsible for 
care. They have communications systems with the clinicians who 
are taking care of their patients. Their communications are bi-
directional, though they are not as robust as they can and 
should be. And an increasing number are using various 
electronic methods to communicate information about their 
patients.
    The direct answer to your question about electronic medical 
records on which we have built our system is that they are used 
in a minority of practices now. It is hard to predict how soon 
they will disseminate very broadly. On the other hand for 
surveillance in communities, it is not necessary for the whole 
community to be served by clinicians who are using electronic 
medical records. Coverage of 10 percent of 30 percent would 
probably serve very well to act as an alerting system. The 
communications part-back from the public health system to the 
clinicians, and through them to their patients-can be 
substantially enhanced by the health plan's existing 
communications mechanisms.
    Mr. Thompson. Thank you.
    Mr. Shadegg. Ms. Dunn to question.
    Ms. Dunn. Thank you very much, Mr. Chairman.
    A fascinating presentation, panel, thank you for being here 
and giving us your time, because you are very helpful to us as 
we try to put some things together.
    I am interested, and I am not quite sure whom to ask this 
question of, but I would like the broad-brush approach. Dr. 
Platt has some excellent pieces of paper that show us where 
there was a collection of outbreak of SARS, I think it was that 
you were showing us. Was that what that was?
    Dr. Platt. It was respiratory illness. There was no SARS in 
Massachusetts that I am aware of.
    Ms. Dunn. My interest is directly related to communications 
with the Department of Homeland Security. So if you come up 
with this sort of an indicator that there is an amazing 
collection of illness in a particular part of our country, how 
long does it take you to decide whether it is a terrorist 
invasion, a biochemical or a chemical weapon of mass 
destruction? How do you get that information to the Department 
of Homeland Security? Do you have to wait until you know it is 
a terrorist-caused outbreak? How do you determine that? What is 
the process you go through, and perhaps Mr. Henderson needs to 
be involved in this too, in reporting that? Let me just add to 
the complications. What happens if we have this occurring on a 
night like last Thursday night when communications were knocked 
out all over the country? What is the process and are we sure 
we are prepared now to be able to get this information where it 
needs to be?
    Dr. Platt. I will begin and then defer to Mr. Henderson. 
The system that we have built is a real-time system. That is, 
it is possible to know very soon after the clinical encounter 
that there is a cluster. That is a considerable achievement. 
Interpreting that cluster really lies within the domain of the 
public health system. That is the point where I hand off.
    Mr. Henderson. Nice segue. There are a couple of pieces to 
this. In my testimony, I talked about the creation of a bio-
intelligence center, because we do need to have this data that 
is collected locally, analyzed locally first, and then of 
course captured on a national level and analyzed rapidly and 
then disseminated back to all the stakeholders who have a stake 
in making a decision to determine whether or not to fully 
investigate what they would perceive to be a potential blip on 
our radar that might indicate we have either a terrorist event 
or we are starting to see a potential emerging infection 
disease in our population.
    So what we are looking to put in place as far as overall 
infrastructure I think amplifies our abilities to do that. I 
think today if you were to see clusters of disease, for 
example, generally young healthy people showing up in emergency 
departments, we are absolutely positively dependent upon those 
clinicians to call, be suspicious, and then depend upon the 
local and State health agencies to contact CDC so we can all 
support whatever response may be needed to investigate that and 
determine the extent of the potential issue in that community.
    The question you raised about how soon would Homeland 
Security know, the minute that we find out from CDC, our 
emergency operations center communicates with the Secretary's 
command center in Washington. They are our vital link to the 
Department of Homeland Security. We essentially follow the 
command and control procedures that you see with the national 
incident management system. So there is that day-to-day ongoing 
connectivity, even when we see cases of disease say a full-
blown illness outbreak, which we have been supporting at the 
State and local and Federal level for years. We include that 
information in our daily situation reports that go to Homeland 
Security, so they always have a sense of our background level 
of activity so that if they start to see an increase in that 
activity, they can work with us to determine if we need 
additional resources to contain and control the event.
    Ms. Dunn. That is very helpful. How does that connect to 
the Department of HHS, the stockpile, for example, of 
antidotes? Does that come from the Department of Homeland 
Security, the request to enter?
    Mr. Henderson. Keep in mind the operational responsibility 
for the strategic national stockpile is at CDC. We work very 
closely with Homeland Security on managing the stockpile. We 
have done this through exercises and we actually did this in a 
few real circumstances. The request comes to CDC. We process 
the request and get approvals from both the Secretary of Health 
and Human Services and Homeland Security at the same time. When 
we have done this through exercises, it is done literally in a 
matter of just 1 or 2 hours.
    Ms. Dunn. What happens if all communications are out? What 
do you do then?
    Mr. Henderson. We have redundant communications 
capabilities.
    Ms. Dunn. Good.
    Mr. Henderson. That is very similar to the Secretary's 
command center in Homeland Security and the National Command 
Center in the Pentagon. We follow a pattern to have that 
redundant communication capability. The one issue you brought 
up that we realized during the blackout of a few weeks ago is 
that our health alerting technologies are all dependent upon 
electronic transmission of an e-mail, essentially. So we were 
putting out health alert notices to talk about your water 
systems, what to do with food that would spoil in your 
refrigerator. Obviously, it is getting to all the people who 
have electricity and not getting to those who don't.
    Ms. Dunn. The ones that have the problem.
    Mr. Henderson. Right. One of the lessons that we learned 
from a visit to Israel was they have a standing public radio 
station that is always there that people know to tune to, and 
we have had discussions at Homeland Security about standing up 
that radio station so that people would know in a power outage 
when they pull out their family preparedness kits which include 
a radio and batteries, they would know this particular channel 
to tune to to get information in the absence of power.
    Ms. Dunn. Good. Thank you very much.
    Thank you, Mr. Chairman.
    Mr. Shadegg. Mr. Turner to question.
    Mr. Turner. Thank you, Mr. Chairman.
    I want to direct my question to Dr. Trent and Dr. Keim. You 
have heard, and I am sure you are very familiar with, the pilot 
projects that place environmental sensors in different 
locations in our country to collect air samples, which are then 
collected and analyzed.. We could spend a lot of money doing 
that. What I would like to know from you, and have your expert 
opinion on, is whether it is better to proceed with investing 
millions of dollars in environmental sensors, or should we-and 
specifically can we-develop a biomedical center that could be 
used for immediate detection of infectious diseases, whether it 
is an engineered pathogen or a naturally occurring one; I'm 
referencing a device that could provide a diagnose within 
minutes after a blood sample was taken. Then whether we could 
develop the capability to analyze that information and be able 
to develop a response to it in a short period of time?
    I know I am asking for the moon and the sky here, and I 
know we all understand that our traditional patterns of 
developing vaccines takes years, but if I was asking today for 
what I think is the answer to dealing with the terrorist threat 
that I know we are going to face just as soon as they gain that 
capability, it seems to me that we have got to have an ability 
to detect these threats once symptoms manifest themselves and 
the ability to then rapidly develop a response, a treatment, or 
an antibody.
    I also would be interested not only in your advice as to 
whether we have the capability to do that, but whether that 
approach could also be helpful in dealing with ordinary 
illnesses, so that we might not pass out quite as many 
antibiotics in this country when, as all of us know, 
antibiotics are over prescribed and over used. Could we find 
some dual use in that kind of capability that would allow us as 
a government save money in other areas of healthcare, simply 
because we have been willing to make this kind of commitment to 
protect Americans against terrorism? but also to protect us in 
other public health areas.
    I know this is a big wish list, but I just want to know if, 
from your vantage point, it is feasible, what would the costs 
be, and whether there are some offset savings.
    Mr. Keim. That is a great question. I don't know where to 
start on that, except to say that we will always in this 
country need to have some type of environmental monitoring. The 
Super Bowl is a good example, or the Olympics. There are places 
where we are going to have environmental monitoring. But we are 
not going to be able to protect this entire country through 
environmental monitoring. The task is just incredible. The 
spatial scale and the breadth of pathogens that we are talking 
about that can be used in bio-crimes or bioterrorism events are 
just too enormous.
    However, if you focus upon the point, which is the patient 
and the individual, and we start to use our genomic information 
and knowledge about human response to pathogens, I think that 
there is a real key here for where we can start to unify this 
monitoring. Again, it starts with the clinicians at the public 
health sectors, and then accumulating that information. A good 
example of what you talk about are in fact these strep tests 
that pediatricians use every day to try to decide if you give a 
kid antibiotics, if you say it is a virus or if it is a 
bacterial. So that is a very rapid, high-value of information 
that comes back to physicians, allowing them to make clinical 
decisions and therapy decisions right then and there. I think 
that this is not going to be available in 6 months, but I think 
it will be available in 2 to 5 years. I think that is the 
scale, and we have to invest today if we are going to get there 
in 2 to 5 years.
    Mr. Turner. You are talking about a detection device that 
could be made available to a local hospital or a local doctor's 
office?
    Mr. Keim. That is right. Your point is also very good about 
branching out. If we are focusing upon the patient, we are 
going to be moving beyond just whether it is anthrax or plague 
or smallpox, which is really a very low return on your day-to-
day operations. But in fact if you are starting to get back 
more information to physicians, it is just going to move over 
into all of these different pathogens that they are going to be 
using on a daily basis. That is the only type of system that is 
going to be sustainable in the long term. If you going to focus 
for the next smallpox attack, we are going to lose interest in 
this country very quickly. Yet if you are monitoring and 
physicians are getting feedback on these diseases on a daily or 
even an hourly basis, they are going to use them and they are 
going to use them on a regular basis. Then we will be ready for 
when hopefully that one bioterrorism event occurs next.
    Mr. Turner. So you can develop the device to know what you 
are dealing with.
    Mr. Keim. Absolutely.
    Mr. Turner. That is within the realm of possibility?
    Mr. Keim. Absolutely.
    Mr. Turner. Can you answer the question I asked about once 
a diagnosis is made whether we can develop a capability to 
develop some response to it in a shorter period of time than we 
normally have available today?
    Mr. Keim. I think we have some great examples of where that 
is already occurring. The response to HIV may have taken us a 
decade, but we could not have done that 10 or 15 years ago. The 
therapeutics that are available now for HIV-AIDS patients are 
an amazing success story of our development of drugs in 
response to infectious diseases. You are probably asking can we 
do it in minutes. Well, if we have to respond in minutes, 
physicians are going to have to go for what they have on the 
shelf now, and in many cases that will be adequate. 
Antibiotics, there are new antivirals cropping up. Even without 
knowing exactly what that pathogen is, there have to be 
strategies that would be preferred or more probable of having 
success, given our knowledge of what is going on and how the 
patient is responding to this event.
    Mr. Turner. Who is responsible for detection the private 
sector or the government? What entity is going to be 
responsible for responding to the unknown?
    Mr. Keim. Traditionally it has always been a partnership 
between the private sector and government. Government usually 
has to invest money into the high-risk aspects, and then the 
private sector can pick up and run with the more commercially 
viable commodities such as the drugs that can make money. Those 
drugs would not be possible if the government does not sink 
that investment money in it, and maybe years ahead of time. So 
that is a very important component of the success in our 
biomedical area.
    Mr. Turner. Thank you. My time has expired.
    Mr. Shadegg. Dr. Christensen to question.
    Ms. Christensen. Thank you, Mr. Chairman.
    I would like to just make a few comments for the record. I 
want to thank you for this hearing. It is getting closer to 
some of those critical issues that we have been advocating for 
since this committee was established. While I am happy that we 
have begun to look at some of the more basic and important 
issues, I am still concerned that we are perhaps missing the 
mark because we are not, at least at the same time, focusing on 
the infrastructure needed to mount the response. I see my 
fellow family physician nodding in assent, as I was during your 
testimony.
    If we know what we have and we are not able to respond 
because the facilities are not prepared, labs are not up to 
date, staff are not properly trained, we will not save lives. I 
think when we even look at the SARS epidemic, it is plain old 
ordinary public health and I am sure a lot of family physicians 
and other primary care providers saved the day. So I still hope 
that we will take a look at where our public health 
infrastructure is, because that is really critical.
    I know that in a demonstration program, Dr. Platt, if I 
read it properly, it deals with people just in the plans. It is 
a demonstration program, so it is really people in plans. As an 
African American and knowing that people of color are over 50 
percent of the uninsured, and that our communities have the 
worst public health infrastructure, I am concerned and I am 
wondering how would we propose to do surveillance in 
populations that wait until the last minute to get care because 
they just avoid it, and those where there are not culturally 
competent physicians, they may be understood, so diseases may 
not be picked up. How do you propose to do that? If I was a 
terrorist, I would go to the weakest place, right there.
    Dr. Platt. You are touching on an enormously important and 
difficult problem. Our horizon really is the medical care 
system such as it is. The couple of things worth noting are 
that all of the plans that we deal with have quite diverse 
populations. On the other hand, they are all people who have 
some kind of insurance. But we are also in discussion with 
local health departments that are the providers of care of last 
resort in many communities, and are far along in discussions 
about having them behave like health plans with respect to the 
system.
    So it is our expectation that in the very near future we 
will have a new major contributor of data that is a local 
health department that is responsible for the care of the 
indigent population. It is a little different from the usual 
defined populations that we deal with. On the other hand, it is 
a recognizable population, too. So it is our expectation that 
to the extent that this mechanism proves to be useful, it can 
also be a useful aggregator of information that comes from 
those provider systems that deal with the traditionally 
uninsured populations.
    Ms. Christensen. I recognize that you stress the importance 
of the public health, the private sector and academia working 
together. This is a concern that I always have and I think we 
all should have.
    Dr. Temte, I quoted you in our press conference today. It 
is always good to have a fellow family physician on the Hill. I 
think Representative Thompson probably asked my question around 
the communication between the CDC, for example, and the private 
physicians. If you wanted to add to you answer, I would 
appreciate it. But I was also wondering how much and how 
accessible have you found training to be for physicians in 
bioterrorism, and who has offered it, and have many physicians 
in your community taken advantage of it?
    Dr. Temte. I will answer your question, and I am going to 
pick up a former point before that, and that is the whole area 
of access to care, which I think is so very important not only 
in urban clinics, in urban settings, but also rural areas. I 
practice in a medically underserved area in an urban center in 
Madison, Wisconsin, in a very diverse patient population. The 
patients that I see that have disease that is far advanced, for 
example, a diabetic coming in with a toe that is gangrene, are 
my patients who have no insurance; who feel disconnected from 
the community.
    I absolutely agree with your statement that if I were a 
smart bioterrorist, I would target an inner-city uninsured 
group of people with a lot of illegal aliens. I would target 
them with something that is contagious and it would brew there 
and it would seed, and they would take it into emergency rooms 
where they will sit for 10, 12, 14 hours and infect people 
there. And a number of them, like a number of our patients once 
they get sick, would head to Mexico because they can get care 
there. So I really pick up on that point on access to care. We 
have systems that will pick up things if someone is insured, 
but we don't pick them up very well if they are not insured.
    Another point was made about systems by which we can get 
lab tests on all patients with respiratory illness, for 
example. There are close to 800 million ambulatory care visits 
in this country each year; 11 percent of those visits are for 
acute respiratory infections. When you look at any laboratory 
test, and especially if you have one that will give you the 
answer on 300 different pathogens, I can assure you that a 
number of those are going to be automatically falsely positive. 
If I am a clinician and I do a test on a patient and it shows 
positive for anthrax, what happens if I go to my local news 
media and say, hey, I have a patient here with anthrax; or hey, 
I have somebody with smallpox. This is a reality of any lab 
test. There are false positives and false negatives, and there 
will always be false positives and negatives.
    So you have to be very, very careful when you apply a test 
to a broad population that is less than perfect and you are 
looking for something incredibly rare. Responding to false 
positives is incredibly expensive. We need to get some 
information from our public health sector about how much it 
costs to chase down false positives when they emerge.
    I really got off the track there.
    Ms. Christensen. I am glad that you took the time to give 
that response as well. Go ahead.
    Dr. Temte. I got so far off the track that I forgot the 
question. My apologies.
    Ms. Christensen. I was just wondering, as a practicing 
family physician, how accessible is training for physicians in 
bioterrorism?
    Dr. Temte. An excellent question. To best define that, I 
think you have to look at what type of training is appropriate. 
There was a consultation at CDC in January 2002 looking at how 
do we train clinicians for bioterrorism and other emerging 
threats in the public health sector. There is a real 
differentiation between just-in-case training and just-in-time 
training. Just-in-case means going out and training clinicians 
to be very aware of the symptoms of tularemia for example. I 
have given talks on tularemia and I would have to go back to my 
notes to look up what the symptoms are, because it is just not 
important to me.
    Just-in-time training, however, is when there is a threat 
out there, then we can get information that is factual, that is 
reliable, and that is very succinct and takes no more than a 
minute for a busy clinician to look at. If we can get 
information like that, and I will give a big nod to CDC, their 
information on the Web pages for clinicians is wonderful. I 
used that a lot for SARS. Because Wisconsin was the epicenter 
of monkeypox, I used the information there and was up very 
quickly. The information for clinicians on monkeypox was posted 
on June 12. This is just within days of the diagnosis being 
made. So the communication aspects to clinicians are very 
important.
    Let me give you one other example. I gave a grand rounds in 
bioterrorism to my hospital in June 2000. I had a handful of 
clinicians come. Their response was, this is interesting, but 
not very relevant. In November 2001, I gave basically the same 
talk to the best-attended-ever grand rounds at our hospital, 
where not only were there family doctors and cardiac surgeons 
and neurosurgeons, but the anesthesiologist and the support 
nurses and everybody else was there.
    There has to be systems to get information out very 
quickly, train out very quickly, but I do not think it is going 
to work very well to get training on multiple pathogens that 
are irrelevant to everyday practice done in a advance.
    Mr. Shadegg. The time of the gentlelady has expired.
    Mr. Shays to question?
    Mr. Shays. Thank you, Mr. Chairman. Mr. Chairman, thank you 
for holding what is a very, very important hearing. I 
appreciate our panelists who are all, I am sure, giving this a 
heck of a lot of thought.
    In my Subcommittee on National Security, we had a doctor 
with a major medical magazine 4 years ago before September 11 
express at the end of the hearing his major fear, and his major 
fear was that a small group of dedicated scientists could 
create an altered biological agent that could wipe out humanity 
as we know it. I am learning that that may be a fear that is 
unlikely, but still possible.
    When I was meeting with the World Health Organization in 
Geneva, they told me SARS is going to be back, and that there 
are 30 other new pathogens out there and who knows what. So I 
am struck by the fact that whether it is man-induced or natural 
causes, this has tremendous benefit for society and we probably 
should have done it a long time ago, even if there wasn't the 
threat of terrorism.
    What I would like to know is a few things. I would like to 
know how we fuse the non-patient specific data with the 
patient-specific data, like pharmaceutical sales and health 
plan nurse call-in topics and so on. How does that all get 
integrated? I do not know who I should be asking.
    Mr. Henderson. Probably I should be the first to touch on 
this, and then Richard you may want to add something to it.
    Right now, it does not happen. It happens in some 
localities, for example New York City where they have looked at 
data post-9-11 and they are trying to find ways to assimilate 
that data and have it influence their decisionmaking. In my 
testimony, I talked about the creation of the bio-intelligence 
center which is a conceptual process at CDC where we are 
looking to take these streams of data, have algorithms 
developed that will allow us to look for any suspicious 
clusters of disease presence in the population, and then 
provide information back rapidly to States and local public 
health agencies. We have not completely developed that yet, but 
we are moving fast and furious to do that.
    Mr. Shays. Will we have to pay people to provide this 
information every day? Or will we just require it by law?
    Mr. Henderson. That is a good question. I think the data 
that we are talking about, at least as it supports this notion 
of bio-science, is already existing streams of data that I 
believe we are going to depend upon to help give us some 
information. As we build our bio-intelligence center and we see 
that there is other valuable data components that we would like 
to feed into that, we may have to buy it. We may have to ask 
for legislation, if in fact we find the data to be that 
valuable.
    Mr. Shays. I would think right now, though, that you would 
find a lot of folks out there who want to cooperate. Is that a 
fair statement?
    Mr. Henderson. Yes.
    Mr. Shays. Okay. Who could speak to the technology that is 
involved in this effort?
    Mr. Henderson. I could refer to Dr. John Loonsk, who is 
with me. He is our director of informatics at CDC. Perhaps John 
could add a few comments.
    Mr. Loonsk. Thank you. I am John Loonsk. To partly address 
your question about costs, there are a great number of people 
who are interested in providing data for these purposes, but 
there are still costs to get data out, to integrate the systems 
to make them work together. That is one of the costs that we 
face.
    Technology is also an issue involved with what Dr. Platt 
spoke about earlier, which is that electronic medical records 
do not exist consistently nationally, and where they do exist 
they do not always store the same data. When you are collecting 
that data to use them together, that becomes an issue, so that 
you want to compare similar data and use them in a similar way. 
But there are a number of other data sources that are viable, 
such as clinical testing that is done; there is interest in 
over-the-counter drug sales and how they may be predictive for 
populations that are not represented in traditional health care 
as well.
    Mr. Shays. And will we be collecting this information state 
by state, or are we looking to do it nationally? What is the 
model going to be?
    Mr. Loonsk. Some of the data sources are very specific and 
very local, an individual hospital.
    Mr. Shays. I know it is local, but is it going to be sent 
to a State repository or is it going to be sent to a national?
    Mr. Loonsk. The proposal in BioSense is to share the data 
at national, State and local levels, to be able to provide the 
data to the jurisdiction that is analyzing those data.
    Mr. Shays. I am a little confused by that. The model we are 
using right now is it is going State and the State is then 
sharing it with the Federal Government? Is that basically what 
we anticipate happening or are we going to bypass the States 
and just send it right nationally? Or do we know?
    Mr. Loonsk. We anticipate both these paths actually to 
exist for some time. The traditional path of clinical, local, 
State, Federal and we think we can leverage data sources that 
may be accumulated at the national or regional level and use a 
single connection to that data source to then provide it to the 
State level or to the local level.
    Mr. Shays. Thank you.
    Thank you, Mr. Chairman.
    Mr. Shadegg. I thank the gentleman for his questions.
    I am just going to advise the members of the panel that I 
am at least going to ask one question in a second round, and I 
have let Mr. Turner know that he may do so if he would like to.
    I want to follow up quite frankly on Mr. Turner's 
questioning. He asked some questions about the issue of 
environmental sensing, and I understood Dr. Keim to say that 
environmental testing was going to be a part of what we needed 
to do, and certainly there would be areas where you could do 
environmental testing. You mentioned sports arenas or something 
of that nature. But that environmental testing of the entire 
nation may be looking too far for that prospect.
    I want to focus on the other type of testing, which is what 
I understand Project Zebra to do, which is testing which occurs 
on a patient-specific basis. There was some discussion here 
which has confused me on false positives. When you do a lab 
test, you can get a false positive. Everybody understands that. 
What I am trying to get a clear understanding of is that as I 
understand Project Zebra, it is the development of the analytic 
information and the loading of information into a testing 
device that could be inexpensively purchased and created, 
inexpensively enough so that as I understand it it could go in 
an average practitioners office or in an emergency room where 
there were uninsured patients or illegal aliens or others in 
the country who were not insured. And that through using 
genomics, it can test for at least these bioterror pathogens 
that we are interested in and give you a result back, and give 
that result back, as I understand it, instantaneously. My 
question is, is that correct, that understanding of the way 
Project Zebra is working? And how realistic is it?
    Finally, using genomics to perform those tests, do we 
eliminate the possibility of false positives or false 
negatives? Or do we diminish it dramatically? Where do we stand 
with that?
    Mr. Trent. Starting with the last question, you absolutely 
will never eliminate entirely false positives or false 
negatives from any test. Anyone who testifies to the contrary 
would not gain credibility with anyone, I am sure, including 
this committee. Certainly we recognize that. But there are 
clearly going to be occasions, including for example the 
unforeseen but difficult situation of thousands of individuals 
presenting for triage within an emergency response center that 
rapid identification may be an important component of the 
triage process.
    The power of genomic technology will allow us to identify 
fingerprints for many pathogens. It won't eliminate completely 
by any stretch of the imagination false positives. But if we 
are looking for a Zebra of course to other common physiological 
responses in the context of a smart physician looking more 
broadly than just a single test. They don't do that now. They 
look at a test, incorporate it with the rest of their 
information, and then make a judgment. I think that we want to 
be believe that these type of approaches will add value to the 
practice setting in the combination through an educated 
physician.
    Mr. Shadegg. Is it practical to develop a machine at that 
expense level?
    Mr. Trent. I think so, absolutely. I think the goal for 
this type of a project and others like it are to have the 
testing cost driven down to a level to where it can occur 
within a population base, and that the actual detector 
instruments have to also be driven down in the cost estimates 
to be able to be placed within the framework of physicians's 
offices. So the answer is absolutely.
    Mr. Shadegg. Thank you very much.
    Mr. Turner?
    Mr. Turner. Mr. Henderson, you mentioned that we are doing 
some experimental work with those environmental sensors, called 
BioWatch and we are funding that research, I assume. Are we 
doing any research into these biomedical centers that Dr. Trent 
is referencing?
    Mr. Henderson. We are clearly supporting the research that 
is being done. At CDC we have looked at a whole variety of 
hand-held devices to determine whether or not it would actually 
prove valuable. I have to say we have dedicated a lot of time 
and effort in responding to events that were triggered by some 
of the hand-held devices, not these particular devices, that 
were all not true events, and created a lot of problems, 
frankly, in our response systems.
    The one thing I just wanted to mention because it seems to 
me there is a theme forming around the use of these early 
detection systems. When looking at detecting a pathogen in the 
population, it is critically important that we have the tools 
necessary to confirm a particular organism as soon as possible 
for those first few cases. You will not continue to look to 
detect and confirm in every single instance once you see you 
have certain diseases in the population. This is where we 
become more dependent upon case definitions, because then the 
focus has to be on your response and how can you rapidly bring 
about the countermeasures so that you can halt disease 
transmission and reduce the severity of the illness and 
hopefully prevent additional deaths.
    I just bring that to the committee's attention because it 
is important to know that. We would not look for hand-held 
devices per se for every case where a person has certain 
symptoms to confirm that this particular person is sick because 
of this causative organism. It would be invaluable if we had 
that, but we would be more focused on bringing the intervention 
in to play so we can reduce the impact of the particular 
outbreak in a population.
    Mr. Turner. You mentioned hand-held devices. When I asked 
Dr. Trent the question earlier, I was envisioning devices that 
had a broader use than just detecting some of the traditionally 
known biological agents that are cause for concern. This would 
be something that would have a dual use capabilities, be 
diagnostic in nature, and be available to hospitals, doctors,--
something that might be placed in the offices where that kind 
of diagnostic tool would quickly give a diagnosis. Is that an 
area that is worth looking into, or worth doing a little 
research on?
    Mr. Henderson. I said ``hand-held,'' and really we are 
talking about portable diagnostic tools that are there at the 
point of service. You are seeing a person who is ill and 
potentially you could confirm that they have a particular 
causative organism, and you know it at the point of service. 
That is an ideal situation. The CDC clearly would want to work 
with any partners that are developing this technology, and we 
have. We continue to do it today.
    Mr. Turner. So there are people out there who are trying to 
develop that?
    Mr. Henderson. Lawrence-Livermore. There are a number of 
labs that we are working with to look into these technologies. 
Yes.
    Mr. Turner. The second issue that I raised was once the 
pathogen is identified by genetic signature, whether anyone is 
researching development of a response capability or shortening 
the time frame for developing an antibody or response to a 
given biological agent? Are we still on this long track of 
developing these vaccines? As you know with Project BioShield, 
once we found the vaccine, then we are going to spend money to 
produce it.
    I am referencing the gap between detection of a dangerous 
pathogen and response--how quickly we can develop a response. 
Are we conducting any work in that area?
    Mr. Henderson. I have to say, to defend my colleague Tony 
Fauci at the National Institutes of Health, I always told him I 
would talk about BioShield in a very positive way, because it 
is very positive. I think it holds out great hope for us to be 
able to rapidly develop the countermeasures that we might need 
to deal with the types of threats and emergencies that we can 
predict we would have to deal with in a very, very fast manner.
    But if you look at diseases like SARS, where there still is 
no treatment for SARS, we rapidly were able to confirm what the 
causative organism was. That helps us determine the type of 
supportive therapy that we would need to provide for the 
patient, so that we could at least assure they would not die 
from the particular illness. I think all of our response 
strategies are looking at the same things that you are offering 
here, is that how can we rapidly detect what the organism is 
and then bring about the delivery of the countermeasure as 
rapidly as possible so you do not have severe illness and 
death. Everything we are doing is to try to minimize those time 
lines.
    If you asked me specifically what are we doing, we are 
working with NIH in trying to push BioShield to the full 
distance we think it needs to travel to help us in that 
respect.
    Mr. Turner. When you mentioned BioShield, I caught in your 
inflection your acknowledgement that it does not deal with the 
development or identification of a response. BioShield applies 
after a response is identified--it deals with mass production 
of the response. What I want to know is what kind of research, 
what kind of investment are we making, whether through CDC or 
NIH or, Ms. Heinrich, any areas that you research, what kind of 
investment are we making to try to shorten that time frame 
between the detection and the development of a response.
    Mr. Henderson. Mr. Turner, can we get back to you in 
writing with a response?

         Questions and Responses Submitted by Joseph Henderson

Question: 1. Are we doing any research to try and shorten the time 
frame for the development of an antibody or a response to a given 
biological agent? Or are we still on this long track of developing 
these vaccines? I am talking about the middle piece between the 
detection of a dangerous pathogen and the determination as to what you 
do to counteract it. Are we doing any work in that area?
Answer: 2. Combating emerging infectious disease is a long term process 
that requires continuous research and scientific development to 
identify appropriate countermeasures to prevent and treat illness. An 
important piece of the long-term model is the development of vaccines 
and drug therapies to fight emerging infections. However, the 
development of countermeasures can be a long process. Take SARS as an 
example. CDC was able to identify and type SARS within a relatively 
short period of time (a matter of weeks). However, the development of a 
vaccine is a much slower process that involves complicated, time 
consuming scientific processes which may not produce a viable 
biological countermeasure for quite some time.
    In the absence of a drug or vaccine, several strategies that can be 
implemented immediately have been developed to limit the effects of a 
disease on the population. Between the point at which an illness is 
identified and a countermeasure or cure is developed, the key to 
protecting the public's health lies in effective interventions, such as 
infection control, supportive therapies and containment strategies, to 
prevent the disease's spread and limit the damage that it can do.
    In this short-term time-frame, CDC engages in a variety of 
activities to prevent the rise of illness in the population and to stem 
the spread of infectious diseases. Once an infectious disease emerges, 
CDC utilizes epidemiology to type the disease (its strain) and to 
identify its cause, source, and mode of transmission. Once this 
information is ascertained, CDC establishes treatment guidelines for 
those who are ill and containment or infection control guidelines to 
prevent the spread of the disease to additional populations. In cases 
where countermeasures do exist, CDC deploys appropriate medical 
supplies (medicine, vaccine, etc.) to localities for distribution.
    Again, we can take SARS as an example of the use of effective 
epidemiology and infection control practices to illustrate the benefit 
of such strategies in the absence of biological countermeasures. Upon 
the identification of the cause of SARS and an investigation into its 
mode of transmission, CDC was able to implement highly effective 
infection control measures (including the monitoring of international 
passengers, use of information pamphlets to those entering the U.S. 
from affected countries, standard infection control practices such as 
hand hygiene in hospitals, schools and homes around the nation) that 
kept the disease at bay in the United States.
    In time, we do expect that biological countermeasures will be 
developed to combat SARS. However, in the meantime, we will continue to 
rely on public health measures to combat the re-emergence and spread of 
SARS.

    Mr. Turner. That would be fine, but I want to know, does 
that answer mean that we are not doing anything? Or does it 
mean that you are just not aware of it? Or are you going to ask 
somebody else? What does it mean?
    Mr. Henderson. I am just not aware of it. I would have to 
ask my colleagues at CDC. I want to give you a definitive 
response because I believe there is research, but I do not have 
the particulars to talk about today.
    Mr. Turner. Ms. Heinrich, do you have knowledge of any of 
those efforts?
    Ms. Heinrich. From our previous work, we know that there 
are a number of efforts underway at NIH at the National 
Institute of Allergy and Infectious Diseases. There is a lot of 
basic research that is going on to really understand the immune 
system and the response to various pathogens. What I think you 
are asking is when we have had a disease outbreak such as SARS, 
is it possible to ramp-up both the public and the private 
sector research capabilities to actually identify antidotes 
that could be useful in the treatment and care of people that 
have this particular infectious disease.
    I think that using SARS as an example, it was really quite 
phenomenal to see the work that went on internationally, 
globally, in identifying the disease agent, as well as at CDC. 
And then how that information was actually used by labs within 
NIH, certainly, to begin to try to identify substances that in 
fact could be helpful in the treatment of SARS. But I do not 
think there is an answer to your question. I really think it is 
going to be highly variable based on the disease agent, to be 
quite honest.
    Mr. Turner. I am just looking for the development of that 
response capability. My distinct impression is that capability 
does not exist in the public or the private sector. If we are 
going to fight bioterrorism in the years ahead, we must have a 
lab fully-funded somewhere with competent people who can deal 
with that. I do not really think it is there, and if any of you 
are aware of its existence in the public or private sector, I 
would really appreciate the information.
    Mr. Shadegg. I appreciate the gentleman's questions, and 
would turn now to Mr. Shays for a second round.
    Mr. Shays. Thank you.
    I did not ask specifically a question I want on the record, 
and I would like each of you to answer. The syndromic 
surveillance system, it is something you think makes sense? 
Should we be investing a lot of money in it or not? I would 
like each of you to tell me what you think.
    Mr. Henderson. Syndromic surveillance, it is a good 
question. It is one of those programs that we find in some 
jurisdictions it works very well. In other jurisdictions, it 
doesn't.
    Mr. Shays. Is it more the urban areas that it works better, 
where you have more concentration of people?
    Mr. Henderson. I think it really depends upon the people 
who are standing up the system; the types of syndromes they are 
looking to report; the reporting entry points; and are they 
willing to put forth the effort to assure that they can capture 
the information and put it into the system, and then maintain 
that level of effort over time.
    We have even seen some jurisdictions where they made an 
investment in syndromic surveillance, but at this point it is a 
waning thing. They just don't continue to see it as being 
valuable. So we have a program at CDC where we are going out 
evaluating the syndromic surveillance systems to see where in 
fact we find value, what are their success factors, and maybe 
that will help identify what is really needed to stand up a 
syndromic surveillance system.
    Mr. Shays. Thank you. Anybody else care to answer, express 
an opinion? Yes, sir.
    Dr. Temte. I believe syndromic surveillance is very 
important in the practice of usual clinical medicine. In that, 
the information flowing from syndromic surveillance can inform 
clinicians about usual trends out there. I agree entirely with 
Mr. Henderson in terms of it depends on what we are looking for 
and what population. But things like syndromic surveillance for 
influenza-like illness are invaluable because they inform us 
when influenza is in the community. It informs us when we can 
expect hospitals to be terribly crowded. It informs us about 
appropriate care, because we know that when flu is around, it 
really narrows down the diagnosis of patients that are 
presenting with fever and a cough.
    Mr. Shays. Thank you. Dr. Platt?
    Dr. Platt. This is a concept that makes every kind of good 
sense. We really have to do the hard work of understanding when 
and under what circumstances it provides information that is 
useful. Then I think we have to make the second decision about 
where to spend scarce healthcare and public health dollars, 
because the support that goes to syndromic surveillance or 
other surveillance systems is support that is not going to many 
other critical needs. We only started this conversation 
seriously a couple of years ago, and I think we will be in a 
much better position to answer your question in a year or two.
    Mr. Shays. Thank you. That is very helpful. Thank you all.
    Mr. Shadegg. I want to thank all the members of our panel. 
This has been a very informative discussion. We certainly 
appreciate your time and your thoughtful testimony.
    We stand adjourned.
    [Whereupon, at 4:45 p.m., the subcommittee was adjourned.]


                            A P P E N D I X

                               ----------
                               --________

                   Material Submmited for the Record

                      Additional Member Statements

 Prepared Statement of the Honorable Shelley Berkley, a Representative 
                  in Congress from the State of Nevada

    I would like to thank Chairman Shadegg and Ranking Member Thompson 
for holding this important hearing to assess our nation's bioterrorism 
preparedness and to investigate what further steps are needed to ensure 
our state and local health officials are adequately prepared to respond 
to a possibility that was unthinkable not that long ago.
    Even before September 11th, we were concerned about the state of 
our nation's health infrastructure. Of particular concern were 
shortages of nurses, the availability of necessary technology, the lack 
of adequate disease surveillance protocols and a generally overburdened 
hospital system nationwide. September 11 th woke our nation to the fact 
that we have enemies ready and willing to take dramatic and 
unconventional action against the United States. This realization 
brings our public health care crises into an even greater focus.
    How would a fragile public health infrastructure respond to a 
disaster involving mass casualties? A terrorist attack demands a 
skilled and prepared workforce working within a broader public health 
infrastructure that requires the tools to tackle such a tragedy. Our 
country's first responders are on the front line of homeland security 
and our government is taking steps to ensure their preparedness and 
protection in the event of an attack, but it must be recognized that 
our nation's hospitals are in the same chain as our first responders 
when it comes to reacting to an attack. In fact, our hospitals are an 
essential link in that chain and must be adequately funded to meet 
potential challenges.
    This past August I had the opportunity to hear from the University 
Medical Center (UMC) in Las Vegas, Nevada, on their terrorism concerns. 
UMC is the largest public hospital in Nevada. In fact, UMC serves a 
10,000 square mile area covering parts of Nevada, California, Arizona 
and Utah. This amounts to a service population of 1.5 million 
residents, plus the 35 million visitors to Las Vegas every year. 
Additionally, UMC is the only freestanding trauma center west of the 
Mississippi River. If a bioterrorist attack was to occur in Las Vegas 
or anywhere in the region, UMC would be on the front lines. However, 
under our federal homeland security programs, public hospitals like UMC 
are neglected. Public hospitals are excluded from receiving the 
resources they need by narrow funding fonnulas and a lack of 
recognition that they too are first responders.
    In August, the Department of Homeland Security held Operation 
Determined Promise 2003, the nation's largest bioterror drill to date, 
in Southern Nevada. Federal, state and local agencies participated in 
an event to test their responses to a possible bioterrorist attack on 
Las Vegas. While this successful event focused on the vital ability of 
our traditional first responders to react to such an attack, UMC 
pointed out a few important factors that were not adequately addressed.
    First, much of the concern during the drill was about 
decontamination measures ``in the field,'' with very little concern 
focused on decontamination ``on-site.'' In other words, funding and 
training has been focused on protecting those working where the 
contamination is first released, but not enough has been focused on the 
ultimate destination of those contaminated, the hospital. In a 
biological attack our nation's health workers will be among our first 
responders, and we will be relying on them to treat those affected and 
to prevent any potential spread of disease or contamination. On-site 
decontamination equipment and facilities are important to protect our 
doctors and nurses, and ultimately our communities.
    Second, public hospitals are essentially excluded from our federal 
homeland security funding programs. Currently, homeland security grants 
administered by the Department of Justice and Department of Homeland 
Security are very strict about what entities a state may award those 
funds. These approved entities do not include public hospitals. There 
is a pressing need for our federal homeland security grant programs to 
be expanded and made more flexible to include our vital public 
hospitals.
    As we have heard from our first responders, such as police and 
firefighters, interoperability of communications must be enhanced. UMC 
also has an essential need for improved communications between the 
hospital and the various levels of first responders, including police, 
fire and emergency medical personnel, in the event of an attack. 
Additionally, UMC requires personal protective equipment, special 
isolation capacity, security-related technology, mobile hospital 
facilities, increased training and specialized personnel. Under our 
current grant programs, these needs go virtually unaddressed.
    Again, thank you Mr. Chairman for this hearing and for the 
opportunity to speak to what I feel is one of the most important 
homeland security issues our nation faces. I look forward to working 
with you and the Committee to ensure that our public hospitals are 
adequately funded and that we avoid depleting existing resources used 
for the everyday treatment of patients in order to meet our 
preparedness needs as we move forward to meet our nation's security 
challenges.
                    United States General Accounting Office
                                  Washington, DC, November 14, 2003
Hon. John Shadegg
Chairman, Subcommittee on Emergency Preparedness and Response, 
        Washington, DC 20515
    Dear Chairman Shadegg: Thank you for the opportunity to 
appear before the Subcommittee on Emergency Preparedness and 
Response hearing entitled ``Disease Surveillance Systems: How 
Can They Help Prepare the Nation for Bioterrorism?'' on 
September 24, 2003. Subsequent to the hearing, you forwarded 
additional questions from Representative Jim Turner, the 
Ranking Member of the Select Committee on Homeland Security. 
Here are Mr. Turner's questions and my response.
        (1) What role does international disease surveillance 
        play in detecting bioterrorism or naturally-occurring 
        diseases? Could it also be very useful for detecting 
        terrorist experimentation with bioweapons? What work is 
        CDC doing with the World Health Organization or other 
        international organizations to promote international 
        disease surveillance?
        (2) What Department of Defense programs exist for 
        disease surveillance and how are these being integrated 
        with CDC? How do you see the DOD programs fitting into 
        civilian surveillance programs? How can they be 
        coordinated with civilian systems? Is there ny 
        unnecessary duplication of capabilities?
    Unfortunately, I am not able to provide specific answers to 
most aspects of these questions now. At the request of Senator 
Norm Coleman, Chairman, Permanent Subcommittee on 
Investigations, Committee on Governmental Affairs, United 
States Senate, we have recently begun a study of both U.S. and 
international infectious disease surveillance systems. Among 
other issues, the study will examine the coordination between 
different surveillance systems, including the CDC and DOD 
systems.
    I can tell you that the CDC works closely with WHO to 
improve international diseases surveillance capabilities. CDC 
is a major partner in WHO's Global Alert and Response Network 
(GOARN) and provides resources (e.g. staff, laboratory 
materials, etc.) and expertise to WHO in epidemiological 
investigations. For example, CDC played a major role in the 
global response to SARS, providing technical consultations and 
deploying staff overseas. On an ongoing basis, CDC also serves 
as a technical consultant to ministries of health on projects 
that address disease surveillance. Through its Field 
Epidemiology Training Programs, the Epidemic Intelligence 
Service, and other programs, CDC has also supported research 
and public health education on disease surveillance around the 
world.
        Sincerely yours,

                                    Janet Heinrich,
                Director, Health Care, Public Health Issues

                           ------------------

   Dr. Platt Response to additional questions from the House Select 
   Committee on Homeland Security, Subcommittee on Preparedness and 
                                Response

Subcommittee Ranking Member-Bennie G. Thompson
Question: 1. In response to a question from the subcommittee regarding 
strategies for improving disease surveillance among local 
practitioners, you briefly described a potential solution that would 
utilize existing health plans to provide better communications and 
interaction with the public health syStem.
    Please briefly expand upon this solution, specifically identifying 
any strategies that might benefit from legislative action at the State 
or Federal level.
    Congressional action may be needed to stabilize and increase 
funding for advancing a health information infrastructure that supports 
early detection and improved interactions between the private and 
public sectors. Efforts at the State and Federal level that support 
current health information technology initiatives and enhance the 
dissemination of electronic health records and other health 
communications rely on stable funding from Federal or state 
demonstration projects and/or financial incentives to build compatible 
information systems. In addition, promulgating the development of IT 
standards will be instrumental in transforming health care generally, 
and improving our ability to detect unusual outbreaks of disease and 
bioterrorist threats.
    Second, it will be important to ensure sufficient funding to allow 
state and local departments of health to fully implement the technology 
improvements that are being developed as part of the Public Health 
Information Network (PHIN), including the National Electronic Disease . 
Surveillance System (NEDSS), and rapid public health communications 
systems.
    Third, it will be worthwhile to create incentives for software 
vendors to incorporate public health surveillance and reporting 
capabilities into their products. These reporting capabilities should 
be under the control of the clinicians and health plans, so that they 
can modify their reporting to accommodate state and local reporting 
needs as well as their own needs. My partners and I believe there is 
special value in enabling providers and health plans to report 
routinely at various levels of detail, including simply the counts of 
new episodes of illness that are the basis of the National 
Demonstration Program I described in my testimony and refer below to 
the model we have developed to provide high level protection to 
individual level data, by having the health plans retain possession of 
individual level data unless there is a need to evaluate a specific 
apparent cluster of illness.

Subcommittee Member-Dave Camp
Question: 1. In your written testimony you discussed Harvard's National 
Bioterrorism Surveillance Demonstration Program. Does your program 
receive any intelligence information or threat assessments from the 
federal government to help focus or supplement your surveillance?
    Our project does not receive intelligence information or threat 
assessments. We recommend this information be provided to public health 
agencies, which can then lower the threshold above which they respond 
to unusual clusters of illness in specific locales. This would allow 
public health officials to evaluate clusters of illness in a particular 
area of interest that they might otherwise choose not to evaluate 
because of other priorities.
    We have asked that our partnering public health agencies ``set the 
threshold'' for detecting possible outbreaks according to their needs. 
One state may want to look more closely at an alert that statistically 
is expected to occur twice per year. Others may want to set the 
threshold very high (once in two years) or very low (once in a month). 
Intelligence or threat estimates could prove useful in establishing a 
more appropriate threshold level as threats are recognized.

Question: 2. Have you encountered difficulties in acquiring the 
necessary data from some hospitals and community health centers that do 
not have adequate or appropriate computer systems or technology? Is any 
progress being made to facilitate sharing this information? What 
recommendations can you give to improve real-time data reporting from 
these facilities?
    As mentioned above, adoption of an electronic medical record that 
captures patient level information during the delivery of care is a key 
requirement to performing ``real-time'' assessments.
    Our project is based on health plans, clinicians, and public health 
volunteering to participate in the demonstration program. The 
participating groups in Texas began their participation due to the 
efforts of a local public health official interested in developing 
their capacity to support improved disease surveillance.
    We are in discussion with community health centers that have 
electronic medical records and an interest in supporting this work. 
Community health centers serve both a ``known'' and a ``dropin'' 
population presenting unique challenges and opportunities for improving 
our surveillance net. Many academic centers sponsor community health 
centers and currently have, or are in the process of implementing, an 
electronic medical record system. These centers are good candidates for 
joining our program.
    Because our system primarily focuses on ambulatory care data, we 
have not actively sought out participation from hospitals. The 
advantage of this is that sick individuals may seek care sooner in 
ambulatory settings than at hospitals or emergency rooms. Additionally, 
our system benefits from knowing how many people are at risk for 
illness in each zip code (members of a health plan); this improves our 
analytical accuracy for detecting a possible outbreak.
    We have developed a detailed plan to evaluate the relative value of 
a wide variety of data streams for bioterrorism surveillance (e.g., 
nurse call centers, ambulatory care, emergency rooms, hospital 
admissions, pharmacy, laboratory and radiology). However, we currently 
do not have funding to carry out this evaluation.

Full Committee Ranking Member-Jim Turner
Question: 1. How do we avoid ``false alarms'' from syndromic 
surveillance systems? Too many of these could undermine the public's 
confidence and might desensitize them to an actual attack. How will 
followup investigations be conducted so as not to overly alarm the 
public?
    There is a tradeoff in setting the ``alarm threshold'' to find 
signals at the earliest possible time while avoiding too many false 
alarms. Our system allows public health officials to set the alarm 
threshold that best meets their local needs. Because our system alerts 
public health and the health plan simultaneously about an unusual 
number of illnesses, there is an opportunity to use the full electronic 
medical records to determine quickly and at minimal cost if an alert is 
a false alarm.
    One of our evaluation approaches to helping health departments set 
the alarm threshold has been to use known infectious disease clusters 
that have occurred in the past and use this data to test our current 
system. The combination of these tests with the actual experience of 
investigating unusual events will mitigate some of the negative impact 
of false alarms.

Question: 2. How is the privacy of the individual patient's medical 
information ensured in your systems? Do you know if other surveillance 
systems have considered privacy issues in their development?
    Privacy of the individual patient's medical information is a key 
feature of our program. We have avoided many problems that other 
surveillance systems must address because our participating health 
plans do not share the confidential health information of their 
members, unless there is specific evidence of a cluster of illness that 
requires follow-up by public health officials. We accomplish this by 
having the health plans routinely report only the number of people with 
new episodes of illness. This is sufficient to alert health departments 
about potential problems and to trigger follow-up. Investigation of 
specific events has been standard public health practice for many 
years.
    Our model thus provides a new method to balance individuals' right 
to privacy and the public health system's need to investigate a likely 
threat.
    It is my understanding that other surveillance systems have 
considered privacy issues in different ways.

Questions and Responses from Dr. Jonathan L. Temte to Member's Written 
                               Questions

Response to Subcommittee Ranking Member Bennie G. Thompson.
Re: Strategies for improving disease surveillance among local 
practitioners

i: Enhanced medical education on disease surveillance
    At present, there is little guarantee that medical students and/or 
medical residents in any specialty receive meaningful training in the 
purpose, role, and practices of the public health system in the United 
States, including issues of disease surveillance. Accordingly, the 
patient-focused healthcare system and the public health system often 
function in parallel instead of interactively. A basic understanding of 
population approaches to health, emergency response, and disaster 
preparedness is an essential component of homeland security. For 
example, a recent study conducted by the American Academy of Family 
Physicians has indicated that prior training of clinicians in 
bioterrorism preparedness was associated with significant enhancement 
of comfort and communication around potential bioterrorism events.
    In 2002, the Accreditation Council for Graduate Medical Education 
(ACGME) mandated that all graduate medical education (i.e., residency) 
programs in the United States must assure that their trainees attain 
competence in six areas:

         Patient Care that is compassionate, appropriate, and 
        effective for the treatment of health problems and the 
        promotion of health
         Medical Knowledge about established and evolving 
        biomedical, clinical, and cognate (e.g. epidemiological and 
        social-behavioral) sciences and the application of this 
        knowledge to patient care
         Practice-Based Learning and Improvement that involves 
        investigation and evaluation of their own patient care, 
        appraisal and assimilation of scientific evidence, and 
        improvements in patient care
         Interpersonal and Communication Skills that result in 
        effective information exchange and teaming with patients, their 
        families, and other health professionals
         Professionalism, as manifested through a commitment to 
        carrying out professional responsibilities, adherence to 
        ethical principles, and sensitivity to a diverse patient 
        population
         Systems-Based Practice, as manifested by actions that 
        demonstrate an awareness of and responsiveness to the larger 
        context and system of health care and the ability to 
        effectively call on system resources to provide care that is of 
        optimal value

    None of these competencies appropriately addresses an understanding 
of public health function or the interaction of public health resources 
within traditional patient care models.

    Proposed Enhancements:
1. Work with the American Association of Medical Colleges [AAMC] to 
support curriculum development and implementation into all U. S. based 
medical schools. Please refer to information available at http://
www.aamc.org/preparedness/start.htm for information on initiatives 
already underway at the AAMC.
2. Work with the Accreditation Council for Graduate Medical Education 
[ACGME] to expand the current six core competencies to include a 7th 
competency on public health function, emergency preparedness and 
disaster response.
3. It may be the appropriate time for Congress to commission an in-
depth strategic report--similar to the Flexner Report of 1910--that 
addresses the gap between public health practice and individually 
oriented medical care and makes recommendations as to the required 
training components and competencies that should become incorporated 
into the training of both public health professionals and medical 
professionals.

ii: Improve public health system interaction with local practitioners
    This is an area where there has been little directed study. 
Accordingly, recommendations on improving health system interactions 
are limited. A recent Agency for Healthcare Research and Quality (AHRQ) 
funded evidence report on training clinicians for response to 
bioterrorist attacks (available at http://www.ahra.gov/clinic/tp/
biotrtp.htm) concluded that there existed only modest evidence about 
effective ways to train clinicians as to how to respond to bioterrorist 
attacks.
    There are, however, several success stories of ongoing interactions 
between public health systems and local practitioners. Perhaps the best 
example is the U. S. Influenza Sentinel Provider Surveillance Network, 
which exists as a cooperative effort between the Influenza Branch at 
the CDC and approximately 1,600 volunteer primary care clinicians 
scattered across the United States. This low-cost surveillance system 
has functioned successfully over the past 30 years, informing public 
health professional and clinicians on the presence and intensity of 
influenza.

Proposed Enhancements:
    1. Ensure sufficient and longitudinal funding for continuation and 
expansion of the CDC's U.S. Influenza Sentinel Provide Surveillance 
Network. This support requires core support of the Influenza Branch at 
CDC, support of state influenza surveillance coordinators, and support 
for primary care liaisons to function as mediators between public 
health and primary care communities. Such funding also ensures an 
ongoing system that can function to detect events that share 
significant features with bioterrorist agents.
    2. Enhance funding through the Agency for Healthcare Research and 
Quality to provide direct research grants for studying effective means 
of enhancing primary care clinician education and performance in issues 
relevant to public health and bioterrorism response. It is highly 
important to evaluate this function of primary care clinicians within 
the United States--the venue wherein most citizens receive most of 
their care most of the time.

iii: Provide better understanding of public health processes to local 
practitioners
    There are few opportunities for healthcare providers to interact in 
meaningful ways with local and state public health professionals. Most 
interaction currently occur around the mandated reporting of cases of 
public health interested (usually communicable disease or significant 
environmental exposures). Few clinicians understand the vital role 
played by public health agencies in outbreak investigation, disease 
control, and public education.
    Participation in sentinel surveillance--in which the clinician 
actively detects cases, reports to a central agency, and receives 
clinically relevant feedback--is a clear example of a means to enhance 
better understanding of public health function. Participation in 
influenza surveillance activities is especially beneficial in this 
regard because response to influenza involves a wide cross section of 
public health activities: local, regional, national and international 
surveillance, vaccination policy, utilization of health care 
facilities, public education. Added benefits lie in the fact that 
influenza-related activities are extremely clinically-relevant, 
especially in primary care medicine. Cases of influenza are commonly 
seen by almost all clinicians and almost every year.

Proposed Enhancements:
    1. Provide funding to enhance influenza surveillance and create 
incentives for the participation of clinicians that will be developed 
into liaison roles, thus helping to bridge the gap between clinicians 
and public health professionals. This could be done at state and 
national levels. A reasonable goal may be two to four surveillance 
clinicians per each U. S. Congressional district.
    2. Create funded, short-term fellowships in public health for 
primary care and other interested clinicians. These could take the form 
of abbreviated ``Epidemiologic Intelligence Service'' training through 
the CDC. The goal would be the creation of a cohort of clinicians that 
would mediate between patient care and public health agendas.

iv: Improve and regularize communications between public health systems 
and clinicians
    There are no systems that currently exist for the purpose of 
regular communication between public health agencies and clinicians. 
Information tends to flow to select clinicians regularly (via 
publications such as MMWR) or irregularly (via local or regional public 
health alerts). Most information to public health agencies from 
clinicians occurs in the form of mandated, reportable illness case 
reports. There is good evidence that many reportable cases go 
unreported and that action steps taken by public health in response to 
reports are not communicated back to the clinician.
    Ongoing information exchange between public health agencies and 
clinicians around topics that are clinically relevant can serve to 
maintain appropriate, bi-directional conduits for communication. 
Excellent examples of this exchange again are found in functional 
influenza and respiratory virus surveillance systems such as the U.S. 
Influenza Sentinel Provider Surveillance System or the National 
Respiratory and Enteric Virus Surveillance System (htp://www.cdc.gov/
ncidod/dvrd/revb/nrevss/rsvtre1.htm). These systems are currently 
limited, however, in the amount of information flow to clinicians.
    A proposed, complete surveillance system is illustrated below 
demonstrating not only reporting of surveillance information to public 
health agencies and feeding back clinically-relevant information to 
clinicians, but also serving as a means to rapidly provide clinicians 
with ``Just in time'' information and education and encouraging 
clinicians to report ``unusual'' events.

[GRAPHIC] [TIFF OMITTED] T0168.034

    One key deficiency is the lack of a reliable and redundant 
communication pathways (e.g., e-mail addresses, fax numbers, telephone 
numbers) of all clinicians.

Proposed Enhancements:
    1. Create a national priority, coupled with adequate funding, to 
establish systems of common disease sentinel surveillance, which could 
be utilized for special circumstance surveillance (e.g., bioterrorism). 
Such a system is ultimately dependent on the availability and flow of 
clinically relevant information to clinicians. A potential first step 
would be to provide funding to demonstration and evaluative projects 
involving primary care, practice-based research networks. Mechanisms 
for such funding currently exist through the Agency for Healthcare 
Research and Quality.
    2. Legislate mandated reporting of each clinician's e-mail address, 
fax number and telephone number as a part of state and territorial 
level licensure procedures to maintain direct and redundant conduits of 
communication.

Response to Subcommittee Member Dave Camp.
Re: Tbe role of primary care physicians in alleviating the fear and 
panic accompanying bioterrorism threats and attacks
    Whereas the subcommittee hearing focused on the detection of and 
surveillance for agents of biological terrorism, an equally important 
component of response exists in the control of panic. To quote from 
Sidell FR et al: ``The real force multiplier in BW (biological warfare) 
is the panic, misinformation and paranoia associated with it.'' [Sidell 
FR, Patrick WC, Dashiell TR. Jane's Chem-Bio Handbook, Jane's 
Information Group, Alexandria, VA, 1998]. And so it goes with 
bioterrorism.
    In the days following the October 2001 anthrax attacks, wholesale 
panic gripped the American public. As a family physician practicing 
hundreds of miles from the nearest case of inhalational anthrax, I was 
amazed at the number of questions regarding white powder that patients 
brought to our clinic. Likewise, the Wisconsin State Laboratory of 
Hygiene was inundated with samples of powder for anthrax testing (see 
figure). The

[GRAPHIC] [TIFF OMITTED] T0168.035

temporal pattern of specimens submitted for testing also describes 
panic well. As the general public was reassured, the level of comfort 
increased, and panic, hysteria and fear declined. To manage 
bioterrorism, one needs to focus on the terror as much as on the 
detection and treatment of bioterrorism related disease.
    To best understand the role of primary care physicians in 
countering the fear and panic associated with bioterrorist threats and 
events, one must first understand the structure and function of the 
U.S. medical system-often referred to as the ecology of medical care 
and the widespread location of primary care physicians. The ecology of 
medical care in the U.S. has been relatively stable for the last 40 
years. Each month, approximately 32.7% of Americans consider a medical 
care visit. Of those seeing a physician, more than half see a primary 
care physician.

[GRAPHIC] [TIFF OMITTED] T0168.036

    It is estimated that family physicians evaluate and manage 
about one billion medical concerns each year in the United States. Many 
of these concerns are best addressed with reassurance, education and 
anticipatory guidance. Primary care physicians, due to basic core 
values, provide longitudinal care to individuals and communities across 
the spectrums of age, gender, ethnicity and race, and affected organ 
system. A central tenet of the primary care physician's relationship 
with his/her patients is trust. Accordingly, it is to trusted 
healthcare providers that patients come with issues resulting from 
fear.
    The widespread location of primary care physicians, and 
specifically family physicians, is noteworthy. Bioterrorist events have 
been and will likely be rather limited in geographic distribution. The 
specific locations of covert bioterrorist events are not predictable, 
but the venue of fear and panic is incredibly widespread. The graphics 
on the following page underscore the wide distribution of family 
physicians in the U.S.
    In summary, following a bioterrorism event, or under the threat 
thereof, individuals with significant fear and panic will greatly 
outnumber individuals affected with a biological agent. These ``worried 
well'' will commonly seek out trusted and available physicians. The 
essential role of the primary care physician, equipped with appropriate 
and up-todate ('just-in-time'') information, is to use the patient-
physicians relationship from which to provide reassurance, education 
and comfort. Efforts to ensure the future supply of well-trained, 
competent and compassionate primary care physicians are of paramount 
important to biological defense and homeland security.

[GRAPHIC] [TIFF OMITTED] T0168.037

[GRAPHIC] [TIFF OMITTED] T0168.001

[GRAPHIC] [TIFF OMITTED] T0168.002

[GRAPHIC] [TIFF OMITTED] T0168.003

[GRAPHIC] [TIFF OMITTED] T0168.004

[GRAPHIC] [TIFF OMITTED] T0168.005

[GRAPHIC] [TIFF OMITTED] T0168.006

[GRAPHIC] [TIFF OMITTED] T0168.007

[GRAPHIC] [TIFF OMITTED] T0168.008

[GRAPHIC] [TIFF OMITTED] T0168.009

[GRAPHIC] [TIFF OMITTED] T0168.010

[GRAPHIC] [TIFF OMITTED] T0168.011

[GRAPHIC] [TIFF OMITTED] T0168.012

[GRAPHIC] [TIFF OMITTED] T0168.013

[GRAPHIC] [TIFF OMITTED] T0168.014

[GRAPHIC] [TIFF OMITTED] T0168.015

[GRAPHIC] [TIFF OMITTED] T0168.016

[GRAPHIC] [TIFF OMITTED] T0168.017

[GRAPHIC] [TIFF OMITTED] T0168.018

[GRAPHIC] [TIFF OMITTED] T0168.019

[GRAPHIC] [TIFF OMITTED] T0168.020

[GRAPHIC] [TIFF OMITTED] T0168.021

[GRAPHIC] [TIFF OMITTED] T0168.022

[GRAPHIC] [TIFF OMITTED] T0168.023

[GRAPHIC] [TIFF OMITTED] T0168.024

[GRAPHIC] [TIFF OMITTED] T0168.025

   PREPARED STATEMENT OF CHRISTOPHER K. LAKE, DIRECTOR, HOSPITAL 
               PREPAREDNESS, NEVADA HOSPITAL ASSOCIATION

    Thank you, Mr. Chairman for holding this important hearing today on 
bioterrorism preparedness efforts, and for giving the Nevada Hospital 
Association the opportunity to be heard. For our nation's hospitals, 
preparing for an outbreak, whether from a bioterror event or from an 
emerging disease such as SARs is of paramount importance.
    The Nevada Hospital Association is one of the nation's National 
Bioterrorism Hospital Preparedness Program administrators. As such we 
work collaboratively with all hospitals, city, county and state 
governmental units and emergency response organizations within Nevada 
and in neighboring jurisdictions. We are responsible for evaluating the 
needs of hospitals and health systems and for the implementation of new 
technologies and equipment providing early identification of potential 
terrorist events as well as to protect our nurses, doctors and other 
biological terror first response personnel.
    In April of last year, we conducted a comprehensive hospital 
assessment and analysis that identifies the strengths, weaknesses, 
opportunities and threats to our healthcare system as related 
specifically to bioterrorism preparedness. Disease and syndromic 
surveillance as well as various technology implementation projects were 
found to be an area where some opportunities exist.
    The assessment documented that more then half of the hospitals 
conduct syndromic surveillance activities and have policies in place 
for practitioners to notify appropriate infection control professionals 
as well as public health officials when needed. The most common 
syndromes that are monitored at regular intervals include: influenza-
like illnesses, rashes with fever, gastroenteritis, sepsis and septic 
shock, unexplained deaths, and undifferentiated pneumonias. It is 
believed that these types of patient presentations at our hospital's 
emergency departments (EDs) will be recognized first by an astute nurse 
or physician and they will in most cases alert the appropriate 
personnel that closer study and evaluation may be warranted.
    It is difficult to automate real time disease and syndrome 
surveillance activities for a number of reasons. One of the primary 
reasons that automation remains complicated is the possibility that the 
initial number of patients that present at EDs will be low as the 
outbreak starts to take off and thus may not trigger any alarms that 
are programmed based on statistically significant variations in patient 
populations or complaint type. When the numbers become high enough to 
trigger an alarm, the outbreak would be large enough for physicians to 
easily identify without the use of the new technology.
    Recognizing these hurdles, the Nevada Hospital Association has 
begun implementing a multi--Prong solution. The first prong is to 
continually reinforce to all healthcare providers, if you see unusual 
clinical presentations or unusually high numbers of the same medical 
complaint think outbreak and alert the appropriate infection control 
personnel. Our second priority is to standardize the syndromes and 
patient presentations that hospitals continually monitor so that all 
hospitals are watching for the same group of diseases affording us the 
ability to identify possibly subtle or smaller clusters of patients 
located within a single metropolitan service area. The third prong in 
our approach will involve the use of technology and the real time 
collection of ED data.
    Nevada EDs are all receiving internet based communications tools 
that will allow each facility the ability to monitor the current status 
of all hospitals within our state. This program will provide a 
magnitude of benefits to help coordinate any healthcare response to 
terrorism including: the ability for hospitals to send alerts to each 
other or to groups of provides requesting help, equipment or supplies 
with the click of a button; the ability to monitor surge capacity 
within the system and; the ability to monitor system- wide critical 
inventories just to highlight a few.
    We are also working with our vendor to develop a biosurveillance 
module that will collect real time data regarding the types of patients 
that are being seen in the hospitals. This device will give doctors and 
nurses an easy to use, non-laborious and quick tool in which to send 
data to public health agencies and track identified potential bioweapon 
syndromes and clinical presentations. The concept of operations is 
simple. Each hospital's communication screen will have a series of 
touch buttons that represent the clinical syndromes to be watched. If a 
physician or nurse sees a patient that presents with one of these 
syndromes they will simply touch the screen. The computer will track 
how many individuals at that particular hospital as well as within the 
State are seeing those types of patients within the last 24 hours.
    Local public health departments and state officials will also have 
the ability to see and monitor all of the syndromes and or each 
hospital individually or in user defined groups. Each agency will be 
able to set alarms if defined thresholds are reached and will also have 
the ability to run reports, query the database and or export the data 
into other health department computer programs.
    We believe this approach will provide the type of information that 
epidemiologist require to begin an investigation. The collection method 
will be fast, simple and non-time consuming freeing up the doctors and 
nurses to be with the patient and not in front of the computer. Lastly 
and perhaps most importantly the system keeps the clinical 
interpretation of potential syndromes with the practitioners and does 
not shift them to a computer routine that could not functionally be 
programmed with all of the possible medical scenarios.
    In conclusion, disease surveillance is a tool which lends itself to 
the use of technology. However, as with most elements of medicine the 
hospitals and individual practitioners remain the first line of defense 
and the primary identifiers of suspected syndromes. Balancing of 
priorities is critical to ensure that any desire to fund new or 
unproven surveillance technology will not compete with the fundamental 
need to adequately protect and equip our hospitals, nurses and doctors 
to respond and treat the patients that will be inevitable during any 
terrorist attack or emerging contagious disease. Thank you Mr. 
Chairman.

                                 
