<DOC> [108th Congress House Hearings] [From the U.S. Government Printing Office via GPO Access] [DOCID: f:89547.wais] HOMELAND SECURITY: IMPROVING PUBLIC HEALTH SURVEILLANCE ======================================================================= HEARING before the SUBCOMMITTEE ON NATIONAL SECURITY, EMERGING THREATS AND INTERNATIONAL RELATIONS of the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED EIGHTH CONGRESS FIRST SESSION __________ MAY 5, 2003 __________ Serial No. 108-55 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpo.gov/congress/house http://www.house.gov/reform U.S. GOVERNMENT PRINTING OFFICE 89-547 wASHINGTON : 2003 ____________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001 COMMITTEE ON GOVERNMENT REFORM TOM DAVIS, Virginia, Chairman DAN BURTON, Indiana HENRY A. WAXMAN, California CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland DOUG OSE, California DENNIS J. KUCINICH, Ohio RON LEWIS, Kentucky DANNY K. DAVIS, Illinois JO ANN DAVIS, Virginia JOHN F. TIERNEY, Massachusetts TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri CHRIS CANNON, Utah DIANE E. WATSON, California ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts EDWARD L. SCHROCK, Virginia CHRIS VAN HOLLEN, Maryland JOHN J. DUNCAN, Jr., Tennessee LINDA T. SANCHEZ, California JOHN SULLIVAN, Oklahoma C.A. ``DUTCH'' RUPPERSBERGER, NATHAN DEAL, Georgia Maryland CANDICE S. MILLER, Michigan ELEANOR HOLMES NORTON, District of TIM MURPHY, Pennsylvania Columbia MICHAEL R. TURNER, Ohio JIM COOPER, Tennessee JOHN R. CARTER, Texas CHRIS BELL, Texas WILLIAM J. JANKLOW, South Dakota ------ MARSHA BLACKBURN, Tennessee BERNARD SANDERS, Vermont (Independent) Peter Sirh, Staff Director Melissa Wojciak, Deputy Staff Director Rob Borden, Parliamentarian Teresa Austin, Chief Clerk Philip M. Schiliro, Minority Staff Director Subcommittee on National Security, Emerging Threats and International Relations CHRISTOPHER SHAYS, Connecticut, Chairman MICHAEL R. TURNER, Ohio DAN BURTON, Indiana DENNIS J. KUCINICH, Ohio STEVEN C. LaTOURETTE, Ohio TOM LANTOS, California RON LEWIS, Kentucky BERNARD SANDERS, Vermont TODD RUSSELL PLATTS, Pennsylvania STEPHEN F. LYNCH, Massachusetts ADAM H. PUTNAM, Florida CAROLYN B. MALONEY, New York EDWARD L. SCHROCK, Virginia LINDA T. SANCHEZ, California JOHN J. DUNCAN, Jr., Tennessee C.A. ``DUTCH'' RUPPERSBERGER, TIM MURPHY, Pennsylvania Maryland WILLIAM J. JANKLOW, South Dakota CHRIS BELL, Texas JOHN F. TIERNEY, Massachusetts Ex Officio TOM DAVIS, Virginia HENRY A. WAXMAN, California Lawrence J. Halloran, Staff Director and Counsel Kristine McElroy, Professional Staff Member Robert A. Briggs, Clerk David Rapallo, Minority Counsel C O N T E N T S ---------- Page Hearing held on May 5, 2003...................................... 1 Statement of: Fleming, David, M.D., Deputy Director for Public Health Science, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; and David Tornberg, M.D., M.P.H., Deputy Assistant Secretary, Health Affairs, U.S. Department of Defense........................ 4 Kelley, Patrick W., M.D., Dr. PH, Colonel, Medical Corps, Director, Department of Defense, Global Emerging Infections Surveillance and Response System........................... 134 Selecky, Mary C., secretary, Washington State Department of Health, president, the Association of State and Territorial Health Officials; Seth L. Foldy, commissioner, medical director, city of Milwaukee, health commissioner, chair, National Association of County and City Health Officials, Information Technology Committee; Karen Ignagni, president and CEO, American Association of Health Plans; and Julie Hall, medical officer, World Health Organization........... 62 Letters, statements, etc., submitted for the record by: Bell, Hon. Chris, a Representative in Congress from the State of Texas, prepared statement of Dr. Hearne................. 122 Fleming, David, M.D., Deputy Director for Public Health Science, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services: Article from Emerging Infectious Diseases................ 56 Information concerning estimate for fiscal year 2004..... 40 Information concerning moneys spent on the National Electronic Disease Surveillance System................. 42 Prepared statement of.................................... 7 Foldy, Seth L., commissioner, medical director, city of Milwaukee, health commissioner, chair, National Association of County and City Health Officials, Information Technology Committee, prepared statement of........................... 77 Hall, Julie, medical officer, World Health Organization, prepared statement of...................................... 88 Ignagni, Karen, president and CEO, American Association of Health Plans, prepared statement of........................ 108 Selecky, Mary C., secretary, Washington State Department of Health, president, the Association of State and Territorial Health Officials, prepared statement of.................... 66 Tornberg, David, M.D., M.P.H., Deputy Assistant Secretary, Health Affairs, U.S. Department of Defense, prepared statement of............................................... 25 HOMELAND SECURITY: IMPROVING PUBLIC HEALTH SURVEILLANCE ---------- MONDAY, MAY 5, 2003 House of Representatives, Subcommittee on National Security, Emerging Threats and International Relations, Committee on Government Reform, Washington, DC. The subcommittee met, pursuant to notice, at 2:01 p.m., in room 2154, Rayburn House Office Building, Hon. Christopher Shays (chairman of the subcommittee) presiding. Present: Representatives Shays, Murphy, Janklow, and Bell. Staff present: Lawrence Halloran, staff director and counsel; Kristine McElroy, professional staff member; Robert A. Briggs, clerk; David Rapallo, minority counsel; and Jean Gosa, minority assistant clerk. Mr. Shays. A quorum being present, the Subcommittee on National Security, Emerging Threats and International Relations hearing entitled, ``Homeland Security: Improving Public Health Surveillance,'' is called to order. As we convene here today, the world is conducting an involuntary, live-fire exercise of public health capacity against bioterrorism. Severe acute respiratory syndrome [SARS], emerged from the microbial hothouse of the Far East through the same vulnerabilities and vectors terrorists would exploit to spread weaponized, genetically altered disease. The global response to SARS underscores the vital significance of sensitive disease surveillance in protecting public health from natural and unnatural outbreaks. It also discloses serious gaps and persistent weaknesses in international and U.S. health monitoring. The lessons of the West Nile virus and mail-borne anthrax have not gone unheeded. Substantial enhancements have been made to the accuracy, speed, and breadth of health surveillance systems at home and abroad. The limited impact of SARS here can be attributed in part to increased preparedness to detect, control, and treat outbreaks of known and unknown diseases. But the public health surveillance system at work today against SARS is still a gaudy patchwork of jurisdictionally narrow, wildly variant, and technologically backward data collection and communications capabilities. Records critical to early identification of anomalous symptom clusters and disease diagnoses are not routinely collected. Formats for recording and reporting the same data differ widely between cities, counties, and States. Many key records are still generated on paper, faxed to State or Federal health authorities, and entered manually one or more times into potentially incompatible data bases. In a world made smaller by the speed of international travel and the rapid mutation of organisms in our crowded midst, the interval between local outbreak and global epidemic is shrinking. Virulent, drug-resistant organisms easily traverse the geographic and political boundaries that still define and inhibit public health systems. Efforts to build a more modern ``system of systems,'' envision routine collection and rapid dissemination of real- time data from public and private health systems and laboratories. Early warning capabilities would be enhanced through the fusion of innovative syndromic surveillance-- automated screening of emergency room traffic, pharmacy sales, news wires, and other public data streams--for potentially significant signs of an outbreak. Pieces of this planned health monitoring system can be assembled at different times and places, but no fully national system yet integrates the observations and communications needed to protect public health from rapidly emerging biological hazards. Successfully operating the elaborate, elegantly sensitive surveillance network of the future will require unprecedented levels of human skill, fiscal resources, medical information, and intergovernmental cooperation. At this moment, sophisticated radars scan the skies and the seas to detect the approach of forces hostile to the peace and sovereignty of this Nation. A similarly unified, sensitive system of disease sensors is needed to detect the advance of biological threats to our health and prosperity. Testimony today will describe civilian and military programs under way in the United States and abroad to overcome the natural and man-made barriers to health monitoring. We deeply appreciate the dedication and expertise all our witnesses bring to this important discussion, and we welcome their participation in our oversight. At this time, we will call on Mr. Bell, who is the acting ranking member today. Mr. Bell. Thank you, Mr. Chairman. I would like to thank you and those who are providing testimony before the committee here today. Today's hearing is critically important to this Nation's security and the safety of its health in general. We are all aware of the need to detect the outbreak of disease and respond immediately and effectively. This could be no clearer than in my congressional district, which is home to the world's largest medical center in the world in Houston, TX. Public health surveillance has been described as ``the cornerstone of public health decisionmaking and practice.'' The events of September 11, 2001, and the subsequent anthrax attacks raise the profile of this issue significantly, so much so, President Bush proposed the creation of ``a national public health surveillance system to monitor public and private data bases.'' He argued that the anthrax attacks of October 2001 prove that quick recognition of biological terrorism is crucial to saving lives; and he proclaimed an urgent need to integrate the Federal interagency emergency response plans into a single, comprehensive, governmentwide plan. But what concerns me most is that there has been no evidence of any attempt to follow through on this proposal. Additionally, the administration's fiscal year 2004 budget slashes funding in core Centers for Disease Control functions. I would hope that our witnesses can clear up the discrepancies between the administration's rhetoric and its proposed funding levels, and I look forward to your testimony. Thank you, Mr. Chairman. Mr. Shays. Thank you, Mr. Bell. At this time, the Chair would recognize Mr. Janklow. Mr. Janklow. Thank you very much, Mr. Chairman. I am going to be extremely brief. If you go back to the period of time just a couple of short years ago when those anthrax letters were mailed around the country, they had the anthrax outbreak, the situation down in the Carolinas, the reality of the situation is, from and after that point in time, phenomenal things have been accomplished. But as you indicated, Mr. Chairman, in your opening remarks, we still have a patchwork in this country that we have a responsibility to overcome very, very quickly. We have cities that have public health laboratories and counties with public health laboratories. We have prisons with public health laboratories. We have States that have public health laboratories; we have private health laboratories. The Federal Government has Indian health service laboratories, they have public health service laboratories, they have military laboratories. We have a whole host of different laboratories, reporting centers in this country, and still a large amount of it is based upon paperwork. And it is incredibly important, it is really incredibly important that in today's day and age, when it is not that difficult to put together reporting systems based upon electronic means--and not facsimile, but far more modern electronic means--that this be done in the most expeditious manner. The Centers for Disease Control frankly have accomplished phenomenal efforts in terms of working with local communities, working with States and communities over the last couple of years. But notwithstanding all the accomplishments that have been made, Mr. Chairman, the fact of the matter is, we are not where we have to be, we are not where we want to be, and we are not where we should be. And so anything that can be done to speed that process up can only be of a beneficial nature to the people of America. Thank you very much, Mr. Chairman, for giving me this opportunity. Mr. Shays. I thank the gentleman for this statement. Mr. Murphy. Mr. Murphy. I will wait and ask questions. Mr. Shays. Wonderful to have you all here. You all are such wonderful, active members of this committee. Before recognizing our witnesses, let me just get some housekeeping in place here, and ask unanimous consent that all members of the subcommittee be permitted to place an opening statement in the record, and the record remain open for 3 days for that purpose. And without objection, so ordered. I ask further unanimous consent that all witnesses be permitted to include their written statements in the record. And without objection, so ordered. At this time, we will recognize our first panel. We have two panels. Our first panel is Dr. David W. Fleming, Deputy Director for Public Health Science, Centers for Disease Control and Prevention; and Dr. David Tornberg, Deputy Assistant Secretary of Defense for Clinical and Program Policy, Department of Defense. Gentlemen, as you know, we swear in our witnesses, all our witnesses. If you would stand, raise your right hands, and then we will take your testimony. [Witnesses sworn.] Mr. Shays. Note for the record that both our witnesses have responded in the affirmative. I should have asked, is there anyone else that might help you respond that might have to say something publicly? If so, we will swear them in. We will start with you, Dr. Fleming, and then we will go to you Dr. Tornberg. Let me just tell you what we do. We do a 5-minute, and then we roll it over for the next 5 minutes. Stop sometime between the first 5 minutes and the second 5 minutes. Please don't go over the second 5-minute. I've never figured out what would happen if you did. Dr. Fleming. I don't want to be the first. Thank you. Mr. Shays. I'm using a little poetic license. It's happened once or twice. OK. STATEMENTS OF DAVID FLEMING, M.D., DEPUTY DIRECTOR FOR PUBLIC HEALTH SCIENCE, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND DAVID TORNBERG, M.D., M.P.H., DEPUTY ASSISTANT SECRETARY, HEALTH AFFAIRS, U.S. DEPARTMENT OF DEFENSE Dr. Fleming. Mr. Chairman, members of the subcommittee, I'm Dr. David Fleming. I'm the Deputy Director of CDC for Public Health Science. Good afternoon. On behalf of CDC, thank you for inviting us here today. We very much appreciate your leadership and attention to the issue of public health surveillance. You know, this weekend when I was preparing my testimony, my 10-year-old asked me what I was doing. And when I told her I was working on a talk about public health surveillance, she said, Wow, I didn't know anybody was interested in that. And, you know, she had a point. Public health surveillance isn't an issue that most people know they should care about; and for that reason, we doubly appreciate your interest in this issue. And in some ways it's funny. Mr. Shays. Given her great insight, would you give her full name for the record. Dr. Fleming. Sure. Absolutely. Her name is Whitney Lynn Fleming. Mr. Shays. Well, she gets it. Dr. Fleming. Thank you. And it's funny, because I think all of us would be fairly concerned if we walked into our personal doctor's office and he or she suddenly started treating us without taking a history or without doing a physical or without doing any diagnostic testing. For public health, our patient isn't a person, it's the community. And just as clinicians need to know about blood pressure and about blood chemistries to diagnose the patients, public health practitioners must have the eyes and the ears and the tools to get the information that's needed to diagnose what's going on in their communities. Although the range of information that's needed to monitor community health is broad, today we are focusing on one piece, the piece that's needed to respond to a biologic threat in a community, to detect an epidemic or a bioterrorist event. And the problem here is that in the early phases of an outbreak, affected people don't turn to public health because no one realizes there is an epidemic. Rather, one by one, affected people seek health care for their symptoms. And to overcome this problem requires a system that, first, recognizes and diagnoses cases as they occur; second, transfers information about those cases to the public health system, where, third, it's analyzed, investigated, and acted on. Now, in this country this critical function is performed by our reportable disease surveillance system. Every physician, every laboratory in this country is required to report specific diseases and conditions to their public health authorities. And, you know, remarkably this system generally works. Thousands of disease reports are initiated each day and investigated each day, resulting in the detection of routine and exotic epidemics. This is the system that identified the anthrax attacks, and odds are it's the system that will identify the next bioterrorist attack on this country. Is it perfect? No. It is the best in the world. But not all reports are complete, not all are timely, and not all are appropriately acted on. It is, however, the core of our detection capacity, and it is the one to work on to make us more prepared. And there is good news here. The bioterrorism resources recently appropriated for building public health capacity have strengthened the system through a wide range of activities, such as increased provider training, improved laboratory diagnostic capacity throughout the country, better linkages between the clinical system and the public health system, and improved public health department 24/7 ability to receive and investigate reports. And these investments are paying off. Our remarkable success in detecting and responding to West Nile last summer and SARS right now are good examples. In addition to these general improvements, let me just mention three specific enhancements that we are working on, and all of them capitalize on the fact that we are at a critical moment of opportunity regarding the use of information technology. First, our current system emphasizes that providers recognize an event so that they can report it. In today's electronic age, there is a new potential that some of you have already alluded to, to use preexisting electronic data bases like nurse call lines or pharmacy records to check for clustering of events that might indicate an unrecognized problem. This type of monitoring is sometimes called syndromic surveillance, and it can supplement our existing disease reporting system. It holds promise for potentially detecting some kinds of events sooner and for providing a richer set of information to monitor and respond to any recognized problem. Second, we are working to improve the transfer of information from providers to public health. Though our National Electronic Disease Surveillance System [NEDSS], program, CDC is moving to move reporting from a paper system to an electronic system by establishing secure connectivity, by agreeing on those critical data standards, and by developing public health expertise that is necessary to make this system work. And, third, we are working on our ability to integrate real-time information from a wide range of sources. You know, our detection methods have to be sensitive, but the price for that is the potential for false alarms. Creating the capacity to rapidly look across a range of inputs to see if one is confirmed by the others is an increasingly critical capacity. And the scope and speed with which a bioterror event could evolve also puts a premium on our ability to monitor the emergence of an epidemic and the response capacities that are needed to fight it. I know the committee is also interested in surveillance at the international level. Let me just quickly say that the detection and tracking of SARS is an example of the international system working right, particularly given the resources that are available in most of the affected countries, and particularly given the fact that the very basics that we are beginning to take for granted here, like laboratory diagnostic capacity and personnel trained in case investigation and response are the rate-limiting need in most of the developing world. So, in conclusion, public health surveillance is as critical to public health as clinical information and diagnostic testing is to the practicing physician. The basic elements of our system to detect a bioterrorist event are operational and increasingly robust as a result of the recent investments that we have made. More can be done, however. In particular, enhancements with a strong information technology component, accessing existing electronic data bases, facilitating electronic reporting, and improving our ability to rapidly analyze a wide range of information sources, once only dreams, are now possible. The challenge now is to make them a reality. Thank you very much. And I would be happy to answer questions. Mr. Shays. Thank you, Dr. Fleming. [The prepared statement of Dr. Fleming follows:] [GRAPHIC] [TIFF OMITTED] 89547.001 [GRAPHIC] [TIFF OMITTED] 89547.002 [GRAPHIC] [TIFF OMITTED] 89547.003 [GRAPHIC] [TIFF OMITTED] 89547.004 [GRAPHIC] [TIFF OMITTED] 89547.005 [GRAPHIC] [TIFF OMITTED] 89547.006 [GRAPHIC] [TIFF OMITTED] 89547.007 [GRAPHIC] [TIFF OMITTED] 89547.008 [GRAPHIC] [TIFF OMITTED] 89547.009 [GRAPHIC] [TIFF OMITTED] 89547.010 [GRAPHIC] [TIFF OMITTED] 89547.011 [GRAPHIC] [TIFF OMITTED] 89547.012 [GRAPHIC] [TIFF OMITTED] 89547.013 [GRAPHIC] [TIFF OMITTED] 89547.014 Mr. Shays. Dr. Tornberg. Dr. Tornberg. Good afternoon, Mr. Chairman, distinguished committee members. I am grateful for this opportunity to discuss the activities of the Department of Defense military health system, and to focus today on those activities engaged in medical surveillance. The military health system, with over 8.7 million beneficiaries, has a global mission that's continually involved in health surveillance. Our medical treatment facilities are daily collaborating, planning, training, and participating in homeland defense operations with our civilian community partners. Our military bases coordinate in the development of mutually supportive surveillance, defense, and consequence management plans. These efforts will be part of the Joint Services installation pilot project demonstrations. Integral to this project is ESSENCE II, the electronic surveillance system for early notification of community-based epidemics. This program is a cooperative venture between the Defense Advanced Research Projects Agency [DARPA], and the Johns Hopkins University applied physics laboratory. ESSENCE II is an outgrowth of ESSENCE I, which was developed for DOD-GEIS. ESSENCE II monitors the National Capital Area and performs syndromic surveillance based on school absenteeism, pharmacy prescription, over-the-counter transactions, emergency room and hospital clinic visits, and other disparate data sources to detect natural disease outbreaks or possibly covert biological weapons attack. A rapid display of clusters of suspicious symptoms or findings provides decisionmakers with outbreak information not currently available. This program shows great promise for providing early detection and response to numerous public health challenges. Medical surveillance of our new recruits and our Active Duty population presents us with the unique opportunity to detect the emergence of infectious illness. This knowledge can impact public health strategies by national authorities. In the past 2 years, virus isolates from military sources have twice driven the composition of the influenza vaccine used throughout the Nation in both the military and civilian communities. Development of vaccines to counter the relentless spread of old and newer biologic threats is a major contribution by Department of Defense laboratories. Current studies include working on improving vaccines for anthrax, Venezuelan equine encephalitis, plague, botulism, and toxins such as staphylococcal enterotoxins, and ricin. Medical oversight and surveillance of our military members from the moment they are recruited until the day they die provides unprecedented opportunity to monitor the potential impact of occupational, environmental, and geographical exposures. The defense medical surveillance system, a longitudinal surveillance data base, allows the Department to capture and then track significant events and exposures throughout a members' accession, training, deployment, and retirement. Improved occupational environmental surveillance programs protect forward-deployed service members' health by providing improved monitoring. The Theater Army Medical Laboratory, the Navy's Forward Deployable Preventive Medicine Unit, and the Army's Center for Health Promotion and Preventive Medicine provide rapid analysis and risk assessment information. To facilitate rapid biologic identification, DOD has supported development of the Ruggedized Advanced Pathogen Identification Device [RAPID], as we call it. This device is a miniaturized polymerase chain reaction [PCR], technology. It's a bioagent detection system that can frequently identify the cause of the outbreak or bioterror attack within 2 hours. This process could possibly take 4 days using standard laboratory techniques to identify agents. DOD has implemented weekly tracking of field clinic visits for various diseases and nonbattle injuries during deployments, and has increased such daily monitoring for current operations in all field clinic reports through command channels at least daily on the current situation, so notification of an outbreak or development of an unusual pattern is relatively immediate. The value to the Nation of these systems extends beyond DOD to industrial agents whose work forces parallel those in the military by providing valuable insight and methods to prevent or mitigate long-term disability. The Department of Defense partners with a number of civil, military, and international partners. The Armed Forces Medical Intelligence Center, an arm of the Defense Intelligence Agency, performs classified and unclassified global medical intelligence to arm theater commanders with the latest environmental, biological, and medical threat assessments. Their unclassified assessment is available to citizens and agencies. Enhanced Federal agency sharing and knowledge exchange is achieved by assigning military epidemiologists to the Centers for Disease Control. Public health service experts are also assigned from CDC to DOD. This sharing of our joint resources and expertise enhances the national response to both local and global threats. In like manner, we have detailed a military medical specialist to the World Health Organization. In the recent severe acute respiratory syndrome outbreak [SARS], the Department detailed a military expert in epidemiology to CDC from DOD-GEIS--and GEIS, as we know, is the Global Emerging Infection Surveillance response system--to provide our unique perspective. Additionally, DOD-GEIS experts were detailed from our laboratories in Indonesia to Vietnam in the outbreak's earliest days. Our experts contributed essential knowledge in the acquisition of specimen collection and biologic identification, and provided skill in transporting specimens. The existing infrastructure of the GEIS global laboratory influenza-based surveillance program was rapidly expanded to facilitate the transport of these specimens. A daily executive summary is issued by DOD-GEIS to communicate not only news with respect to general SARS issues, but also specific DOD information on possible cases, policy guidance, referenced laboratory resources, and surveillance data from ESSENCE and other DOD sources. DOD and service- specific clinical disease control and air evacuation guidance has been disseminated to our forces. To date, we have had no active confirmed cases of SARS. GEIS's mission is directed by Presidential Directive 7, and includes support of global surveillance training and research and response to emerging infectious disease. Recognized by the Institutes of Medicine in 2001 as a critical, unique resource of the United States in the context of global affairs, and as the only U.S. entity that is devoted to infectious disease globally that has broad-based capacity in the overseas setting, DOD-GEIS stands as our commitment to surveillance for emerging infectious diseases in direct support of our national security efforts. Emerging infections, as has been discussed, are a threat to global security and have the ability to harm U.S. interests through reversing economic growth, fomenting social unrest, and complicating our response to refugee situations. Biological terrorism and warfare are additional concerns. The recent emergence of SARS and the inextricable progress of the HIV/AIDS epidemic in Africa have provided ample evidence of the economic and societal damage that infectious disease can cause. During our continuing operations in Afghanistan and Iraq, the military health system has applied the lessons of 12 years' experience since the first Persian Gulf operations. Through a force-held protection strategy, the Department promotes and sustains the health of our service members prior to deployment, protects personnel from disease and preventable injury during deployment, and provides comprehensive followup treatment for deployment-related conditions. A deployment health surveillance program with pre and post-deployment health assessments validates each individual's medical readiness to deploy, and addresses health concerns upon his return. Improved deployment health protection measures are designed to counter an increasingly broad range of threats. Such measures include the fielding of new biological and chemical warfare agents, detection alarm systems, and the operational testing of integrated electronic medical surveillance and emergency response networks. Current vaccines and antimalarial drugs and research on the next generation of vaccines and pharmaceuticals are but some of the many efforts we are engaged in. DOD has coordinated with the VA to address deployment, health-related concerns of both service members and veterans in developing a post-deployment health guideline. This practice guideline and the use of it through electronic information sharing through the Federal Health Information Exchange provides significant improvement in the care of our veterans' health. The military health system participates in the National Science Foundation's multiagency project to prioritize national research agenda for information systems to detect and respond to natural outbreaks or intentional release of biologic agents that target not only humans but plant and animal resources. Economic and health strains and vulnerabilities are being mapped, while requirements for information systems to track, alert, and notify disturbances are being developed. A national strategy involving combining Federal and civil agencies to combat bioterror will strengthen the national response. In conclusion, I am proud to say that the Department of Defense military health system is a solid partner in support of the national public health security through daily medical surveillance and support of the continuing war on terror. I believe that you will find that the military health surveillance has many complementary and overarching systems that cooperate with both other Federal agencies and the civilian medical community. These activities are enhanced through outstanding programs such as DOD-GEIS and the ESSENCE I and II programs. Thank you, Mr. Chairman, and distinguished committee members. [The prepared statement of Dr. Tornberg follows:] [GRAPHIC] [TIFF OMITTED] 89547.015 [GRAPHIC] [TIFF OMITTED] 89547.016 [GRAPHIC] [TIFF OMITTED] 89547.017 [GRAPHIC] [TIFF OMITTED] 89547.018 [GRAPHIC] [TIFF OMITTED] 89547.019 [GRAPHIC] [TIFF OMITTED] 89547.020 [GRAPHIC] [TIFF OMITTED] 89547.021 [GRAPHIC] [TIFF OMITTED] 89547.022 [GRAPHIC] [TIFF OMITTED] 89547.023 [GRAPHIC] [TIFF OMITTED] 89547.024 [GRAPHIC] [TIFF OMITTED] 89547.025 Mr. Shays. I am stunned by the timing of your speech. You had 5 seconds left. Thank you. It was a thoughtful statement. Both of your statements were very helpful. I am going to recognize Mr. Janklow, and then we will go to Mr. Bell and Mr. Murphy. We are going to do 10-minute segments. Mr. Janklow. Thank you very much, Mr. Chairman. Dr. Tornberg, the system that you described, DOD-GEIS, is that suitable for civilian use in America? Dr. Tornberg. It is, sir. It's a developing system. The ESSENCE II is in fact a system that is involved with the civilian community. ESSENCE II is a lab data base analysis and recognition that we are conducting in conjunction with Johns Hopkins. It is based on the National Capital Area and the 21 jurisdictions surrounding it. Mr. Janklow. Dr. Fleming, as I look at your testimony, you cite 30 States that have asked for funding under the NEDSS strategy. Is the NEDSS strategy, is that an end result or is it just part of a process? Dr. Fleming. N.E.D.S.S., or NEDSS as the jargon, is a program that's designed to transfer at the State and local and national level from a paper reporting system to an electronic reporting system. Mr. Janklow. Can you tell me why 20 States have not yet requested funding for that? Dr. Fleming. In fact, there may be a misunderstanding or a misinterpretation. All States are getting funding for NEDSS. Some States, approximately 20, have bought into the concept, but are using the standards that have been developed to develop their own software and process for making this happen. Thirty States have said, no, we don't think we have that technical capacity, and we want to jointly invest in the system that CDC is developing that will allow this to happen. Mr. Janklow. Sir, help me with this. And I understand, you know, interest in open architecture and competitive marketplaces. But why in the world would we be encouraging what looks like maybe one system, based upon 30, that CDC is developing--30 States, in reporting--major reporting jurisdictions, and then 20 more separate ones that all have to be tied together? Frankly, sir, what sense does that make? Dr. Fleming. The fundamental principle that NEDSS is operating on is to say that, independent of whether systems are homegrown or developed outside, that they have to conform to an agreed-upon set of strict standards that assures interoperability. Mr. Janklow. That makes my point, sir. I mean, that's the very point that I'm making. If you have strict standards and criteria that people have to meet, why aren't the other 20 part of the first 30 and all in the same system? Is there a reason, other than good feelings or, you know, good relationships that this is being done? Is this a sovereignty issue or is it a competency issue or what, sir? Dr. Fleming. I think it's actually a good public health practice issue. At the end of the day, these systems will be indistinguishable and transparent from each other as far as enabling the needed transfer of information. But the reality is--is that in different jurisdictions there are different needs and issues such that it does make sense for a particular jurisdiction adhering to a set of standards to say, we want to be able to customize this to meet not only the national needs but our local needs as well. Mr. Janklow. Doctor, if I could, and I'm referencing page 6 of your written testimony: You give examples of different States, the Michigan example, the Missouri example, the Pennsylvania example, and then Virginia, Maryland, and Washington, citing that they are buying into the Pennsylvania example. Where you have an example like, let's just take Michigan. Michigan is implementing a secure Web-based disease surveillance system to improve the timeliness and accuracy of disease reporting. Why would that be any different than what Missouri is doing? And I know the answer is going to be Missouri is doing it, too. But why do they all have to be done in different ways? Because what we are going to end up with is, some jurisdictions are going to be more comprehensive and more thorough than others. And when we're dealing with national information that's coming from all over America, different jurisdictions are going to be reporting or not reporting certain data based on what it is they decide to do. Dr. Fleming. Let me draw a distinction. First, I understand the point that you're making. And rest assured that CDC, as well as State and local governments, are working very hard to prevent what you are talking about from happening. Mr. Janklow. But it doesn't indicate here it's happening. And I'm not trying to interrupt you, sir, but the testimony here indicates that may not be happening. But go ahead, please. Dr. Fleming. And there are really two different systems that we are talking about. In my oral testimony I talked about the reportable disease system that is standardized across the country and which NEDSS is seeking to make electronic with strict standards. In addition, with the availability of electronic medical records and other electronic data bases out there, there is now a new potential as you heard about, for example, in essence to, independent of that system, develop syndromic surveillance that accesses these data bases. We are right now at a stage where pilots and demonstrations and experiments are needed in that syndromic surveillance part of how we detect diseases. We do not yet know for sure how effective that system will be or what the best way to do it is. In that context, we are allowing innovation at the State and local level, under the guidance of CDC, to assess different ways of conducting not this reportable disease surveillance that NEDSS is standardizing, but rather this new enhanced, complementary approach of syndromic surveillance. Mr. Janklow. Doctor, given the history, I will call it in the nonwarfare sense, whether it's botulism, whether it's measles, whether it's other types of clusters--I remember an incident involving the Schwan's trucks several years ago with respect to the ice cream that was nationwide in scope. CDC and the systems in America have done a tremendous job of getting on top of that, meningitis, very, very quickly. What's the difference between the system in place for that and the systems you are describing now, sir? Dr. Fleming. OK. And it's two different approaches that are complementary, that are both designed to try to detect one of these events as soon as they are happening. The system that's a standard system that detects the salmonella outbreak is one where people with salmonella go to see their physician, a diagnosis is made, those cases are reported to the health department, and as a result of cases coming in from multiple physicians, there's a recognition that there is an outbreak of salmonella that is happening, and the appropriate investigation is occurring. Now, there are some conditions. Let's take anthrax as an example, where before someone gets to the point where it would be possible to diagnose the disease anthrax, they have several days of milder symptoms that are influenza-like, if you will, with fever and other illnesses. One potential way of jump- starting our recognition of an anthrax attack would be not to wait for people to come in at the stage where you could diagnose anthrax, but by monitoring reasons that people are coming into emergency rooms or in pharmacy records, seeing that there is a sudden upswing in the nonspecific seeking of attention for an influenza-like syndrome. Mr. Janklow. But isn't that done now? Dr. Fleming. Actually, that's what we are talking about trying to implement with respect to this jargon, ``syndromic surveillance.'' Which is to say, is it possible to implement systems that could pick up earlier in the course of an epidemic some of these nonspecific illnesses that aren't yet diagnosed, and by seeing an uptick, put the public health and the clinical health system on alert? We are right now in the phase, though, of figuring out how best to do that. Mr. Janklow. One thing that the Department of Defense excels at is educating their people. They have a worldwide system that's in place. Recognizing that the traditional method that we follow in this country is to bring a lot of people together for a conference, would it not make sense to start using to a far greater extent, for example, satellite television, recognizing that in a lot of instances it will be video one-way and audio two-way, but that you could really reach an awful lot of people and, frankly, a lot of general public? I think where you are dealing with, especially the new world we live in of terror, the more the general public knows, the more equipped we are as a nation, one. And, two, the better it is in terms of reporting things to their physicians and their medical providers. I mean, it isn't like grandmas and mothers can't look at the symptoms. By the time you get to be a grandma, you know them pretty well. The school of hard knocks has taught you an awful lot. Is there any approach being looked at to more effectively use--like direct broadband, direct broadcast satellites, as opposed to specialty satellites like SS and direct TV? Dr. Fleming. You are absolutely right that with the new technologies we have available to us, we need to be creative and make sure we are staying ahead of the curve of how best to communicate---- Mr. Janklow. Are you doing any of that? Dr. Fleming [continuing]. With people. And so there are a number of avenues that CDC, along with State and local health departments, are doing. One you mentioned is that many people now have access to the Internet, and one of the most effective ways to educate people is by putting information on Web sites, including interactive Web sites. CDC's Web sites gets millions of hits each month. And you can watch it uptick when West Nile comes, or with SARS, when SARS came. So people are using the Internet. Second, we need to take advantage of distanced-based learning techniques, as you have alluded to, via satellite transmissions, Webcasting, via even old-fashioned, if you will, videocassettes that allow people to learn at the time that they are able to do it, rather than going to the expense of bringing people all into the same place. There are many of these kinds of technologies that are now available to us, and we need to be smart and use them, and we are trying. Mr. Janklow. Thank you. Mr. Shays. I thank the gentleman. Mr. Bell. Mr. Bell. Thank you, Mr. Chairman. Dr. Fleming, we've obviously all heard about the anthrax scare in 2001. We read constantly about the threat of bioterrorism, and we pick up a newspaper or turn on the television just about every day to hear another story or see another story about SARS and the spread thereof. I think, given all of that, everybody recognizes the need, the very pressing need, for a national surveillance system. And many, certainly, on this side of the aisle are quite curious to see the cut to CDC in the President's budget to offset a $550 billion tax cut, or what would appear to be a cut in order to offset the $550 billion tax cut--and I'm very curious as to why these cuts to CDC--what impact the cuts would have on the efforts to establish a national surveillance program. Dr. Fleming. Thank you, Congressman. I think there has been a bit of confusion about the nature of the reductions you are talking about. In fact, in the President's 2004 budget compared to the President's 2003 budget, there was actually a proposed increase of $125 million in chronic disease, $50 million for HIV prevention, $10 million for a public health information network, initial development, $5 million for health statistics, $17 million for pay raises. What happened though is that the President's 2003 request was modified by Congress and increased. So if you look at the President's 2004 request compared to what it was that Congress authorized in 2003, there is this difference. From our perspective, it does make sense for the President to operate off the budget that he proposed in 2003. And in that budget there are not any programmatic reductions. Obviously, when the budget comes to you all, you are going to need to sort this out as far as what you authorized in 2003 compared to what you authorized in 2004. Mr. Bell. What about moneys spent on the National Electronic Disease Surveillance System? Dr. Fleming. The dollars that were requested by the President in 2003 for that system match the dollars that were requested by the President in 2004 for that. Mr. Bell. That's been going down every year since 2002, has it not? Dr. Fleming. I could get back to you on the record with the specifics. My understanding is that the amount has been constant, with the exception of an earmark that was deleted. But let me get back to you on the record. [The information referred to follows:] FY 2002 Actual--$27.8 million FY 2003 Enacted--$28.6 million FY 2004 Request--$27.6 million Mr. Bell. Well, let's discuss in a more positive light what progress has been made in bringing the 100 district surveillance systems together under a more comprehensive program. Dr. Fleming. There has been remarkable progress made. Let me say that more can and needs to be done, but within the last year many States have begun actually operationalizing a system where clinical laboratories in their jurisdictions are now automatically and electronically forwarding disease reports so those reports are coming in a more complete and timely fashion. And States like Hawaii have performed brilliant analyses of this that show that they are now better able to detect outbreaks more rapidly and more efficiently than they were before. In addition, there has been absolute commitment at CDC and agreement with our State and local partners that we need to establish a uniform set of standards for developing our information technology systems, and especially those systems that are relevant to biosurveillance. And so, over the last year, for the first time there is a comprehensive list of standards that all of the public health partners have bought into that said, as we move forward, these are the standards that we agree we're going to abide by to assure that a clinical laboratory that reports to multiple jurisdictions only has to do it one way because there will be one set of standards and to assure that, as information passes from one jurisdiction to another, that passage will be transparent, because it will be sent and received in a standard format. In addition, there has been good initial work done on what we are calling the public health information network, which is the underlying information architecture that we need to do all of our business, not just surveillance, but also alerting of providers through routine e-mail communications and training and informing the public. So, we build one system with multiple functionalities rather than multiple independent systems. We have gone a long way. Mr. Bell. OK. But we don't have one system right now as we sit here today; is that fair? Dr. Fleming. That is correct. We are moving toward that single system. But we need to recognize that we were starting from a baseline of many disparate systems, and we need to keep the trains running as we move forward. Mr. Bell. Sure. And I agree with that and I understand that. But what challenges still exist in order to get to that one system? Because I assume from your comments that is the ultimate goal. Dr. Fleming. There are several challenges. I won't deny that resources is certainly part of it. Information technology and these systems are expensive. And in this era where there are finite resources available, tough decisions are going to have to be made. Second, though, we need to look critically at the human capacity, because in fact you can have the best computers and the best information system in the world, but unless there is somebody sitting behind that computer that is knowledgeable and competent and trained and knows how to act on that information, you haven't bought anything. And I think at CDC we are most concerned perhaps about whether or not there is this pipeline of trained public health professionals out there to use this new technology. And, in fact, there may not be. So, a major area that we are looking at in conjunction with our State and local health departments is, what does need to be done with respect to schools of public health and other educational institutions, preparing public health professionals to assure that the work force that we are generating is one that is competent and knows how to take maximum advantage of the system that we are building? Mr. Bell. Dr. Fleming, given the fact that, as you state, resources are one of the challenges we face, is it fair to say, when the amount of money is decreasing that is being spent on the surveillance system, we are not going to get there anywhere fast toward the one system? Dr. Fleming. Moving toward the one system certainly is going to be both resource and people-dependent. Mr. Bell. What kind of money are we talking about? Dr. Fleming. Right now, we are engaging with OMB according to the Klinger-Cohen Act to develop the business case for exactly what it is with respect to this overall vision that we are going to need in the next few years. When that process is complete, we will have a specific target amount that will be needed, and we will get back to you with that. We are working through exactly that issue right now. Mr. Bell. So we don't even know how much it would cost at this point in time? Dr. Fleming. We need to complete our discussions with OMB and under the rules of the Klinger-Cohen Act. Mr. Bell. Is there any kind of estimate available at this-- has anyone made any sort of estimate how much one system might cost? Dr. Fleming. Let me get back to you on record for that. Mr. Bell. I'm sorry? Dr. Fleming. I will get back to you on the record. [The information referred to follows:] [GRAPHIC] [TIFF OMITTED] 89547.026 Mr. Bell. I would appreciate it. It is not your impression--and, Dr. Tornberg, you can comment on this as well--that the administration has stepped away from its earlier desire to see this national surveillance system? Do any of you all get that impression? Dr. Fleming. Dr. Tornberg can comment. I certainly do not. If anything, the administration, and especially the Vice President's office, has been very supportive of the notion of doing what needs to be done to make sure that we have a surveillance system that's competent and, particularly, a surveillance system that can detect not only naturally occurring events but bioterrorist events as well. Mr. Bell. Dr. Tornberg. Dr. Tornberg. I would agree. I think that there is a full commitment to providing a national surveillance system. I have not detected any variance from that point. Mr. Bell. Has everybody made it clear that more money is going to have to be committed to the project if we are going to be able to realize one system? Dr. Fleming. We made it clear that resources are needed to make systems work and that we need to balance the expectations for what those systems are against the resources that are available. Mr. Bell. Thank you very much. Mr. Shays. I thank the gentleman. Before recognizing Mr. Murphy, what I'm wrestling with is one country, 50 States, thousands of local governments, and the comment is made, it's a question of resource and people. It's not a question of legislation that would allow you to mandate one system throughout? Dr. Fleming. Mr. Chairman, I don't think so. Mr. Shays. OK. We will come back to it. OK, you've got it, Mr. Murphy. Mr. Murphy. Thank you, Mr. Chairman. Actually, you were reading my mind. My mind is working along the same lines. In Pittsburgh, we have a system called the Real-time Outbreak and Disease Surveillance System [RODS] system, which has been operating pretty well. And in southwestern Pennsylvania--and, also, Utah used some of this during the last Olympics where they do monitor those very things you were talking about, over-the-counter supplies and pharmacies, etc. And that's one sort of system, and you are looking at others. I just want to make sure I understand this. Are you at this point testing different systems that are being used to determine which one is the best system? Have you determined that yet as different universities are involved in these functions? Dr. Fleming. The RODS system that you are referring to would fall into that category of syndromic surveillance systems, where in fact right now a number of different systems--ESSENCE would be an example; ESSENCE I and II would be examples--are being tried in different jurisdictions. I personally think that the outcome of this is not going to be that one of those systems is going to be proven best, but alternatively we will see the aspects of each that provide the most functionality. And by combining the best of all of them, we will create that, if you will, one system that serves our needs. But we are really right now in a phase of piloting and demonstrating and, to a certain extent, experimenting, because this is new ground for the public health community. Mr. Murphy. So you are working with different places like the University of Pittsburgh and others to monitor the kinds of parts that are in place, so you can pull out of each one what's the best? Dr. Fleming. Exactly right. And in addition, I mean, a key to these--the underlying notion here is that these systems can detect problems more effectively and more rapidly in some instances than our existing reportable disease system, and can be a complement to it. That's a concept that has not been totally proven yet, and before investing a whole lot of resources in a nationwide system, we do need to see the evidence that these systems are able to do what they, in theory, might be able to. Mr. Murphy. Let's walk through what happens next. Say you come up with a national system that's been working in the cities and rural areas, etc. The thing about bioterrorism, it moves slow enough that you can detect and then implement strategies to quarantine, to have public education, to immunize, whatever. But, of course, the drawback is that it also moves slow enough that it can be spread throughout the Nation in a matter of a few days before anybody has a sense that they need to take some steps. When that happens--and we have had some other hearings here, for example, with NORTHCOM, some wonderful hearings and discussing some of the aspects taking place. But let's go--let's say there is some disease that begins to be picked up in multiple cities around the country, it's spreading by whatever mechanism, through contact, it's around. Can you walk us through what happens once you get this data, in particular, the plans in place to notify physicians and hospitals, coordinate efforts, get products to communities, notify the Defense Department, even to the level of local emergency responders, EMS people, etc? Can you walk us through what happens once you identify that there appears to be something out there? Dr. Fleming. It's a complicated question. Let me try to answer it in a couple of ways. First and most basically, the health department needs to be the nerve center for making this happen. What we are talking about is gathering the information through the surveillance systems to allow competency in making the decisions that need to occur. Then, the different arm needs to come in action. The health department, as you have said, works with providers and works with appropriate policymakers to make the right things happen. A fair amount of the dollars that have gone out over the last year for enhancing bioterrorism preparedness have been put in place through plans and exercises, exactly the kind of thing that you're talking about. So even as we speak, health departments around the country are, in fact, making plans, drilling, making sure that they have the ability to connect with the providers that they need to connect with, testing that, making sure that they're connected with the policymakers and others. Mr. Murphy. Is this part--there'll continue to be drills around the Nation? There's funding available for that aspect that communities can also apply and work with health--because you also have State health departments in some--I know in Pennsylvania many counties don't have a health department. They have to rely on the State. It's a slow system. And so it will require some drills and exercise to take care of that. Is that a part of the States as well? Dr. Fleming. Absolutely correct. And let me point out that one of the ways that we are really focusing on using these resources is to invest them in the same systems that are used every day to detect naturally occurring outbreaks and to mount the responses that are necessary to combat those. So in addition to exercises and drills, in fact, we are, because of Mother Nature, constantly being drilled in this country and around the world through the natural everyday public health emergencies that our health departments are facing. Mr. Murphy. Was this 5 or 10 minutes that I have? Mr. Shays. Ten minutes. Mr. Murphy. Ten minutes? Oh good. Let me continue to pursue this. With this kind of data out there, the question becomes one of Big Brother and how do you protect confidentiality of records. And let me add to this, a lot of hospitals are concerned now about HIPAA regulations and problems with confidentiality. So now they can't get the information that they need to track what's happening with patients. Let me continue to build this. As we're working on such things as other aspects of pharmaceutical care for the elderly, without some openness of sharing some records, you run the continued risk of the problems that there are with prescription and nonprescription drugs. Some estimates have been out there about 10 percent--I'm sure you're aware that about 10 percent of emergency room admissions they say are related to some pharmaceutical problems; perhaps the person took the double doses they weren't supposed to. Perhaps a physician did not know what else was being prescribed. They didn't know that the patient was taking over-the-counter products. Someone forgot their medication for 2 days, they took it all at once. The list goes on. And in aspects where pharmacists have data available or where the pharmacy benefits manager may have information available of what else that person is on, it helps them prevent a lot of those accidents. Now, we're looking, too, here at collecting data on symptoms. If it is just looking at sales, numbers for what's happened with antihistamines and pharmacists, that's one thing, but ultimately you have to get down to the level of who has this? That's been part of the elegance of tracking SARS around the world, that you were able to track it down to a hotel in Hong Kong, ninth floor, who was there, and tracking them around the world. Clearly you're going to need some sort of records like this, too, but it has to be looming over people's minds of--on the one hand they want to know if there are symptoms in a town, they want action to be taken to identify that, but also protect confidentiality. How do you walk that line? Dr. Fleming. OK. An excellent question. Let me say first that I think most people in public health would not see it as public health versus privacy, but rather only by protecting privacy can we expect this information to be made available, and so we're on the same side of this. There's a couple of strategies that are used. First there are some kinds of surveillance where you don't need identifying information, and so the first question that we always ask in any of these surveillance systems is can we get what we need without having identifying information there, and if so, let's not get it. But as you pointed out, there are some places where, in fact, identifying information is needed so you can track back to the individual or the individual's provider to get more information to assure that the right things are happening to that person and to take the appropriate actions in the community. This is an issue that public health has been dealing with, you know, for 100 years. And, in fact, on a day-to-day basis, personal identifying information is routinely relayed from the medical community to the public health system, and that information is guarded very carefully both from a legal standpoint and from a security standpoint so that there have been few, if any, breaches in the history of public health where an individual's confidentiality has been compromised, and that's by maintaining attention to the sanctity of privacy and, when information that is identified is obtained, making sure that it's used wisely. That's the answer. One last thing about HIPAA is that there is a lot of confusion out there, obviously, and we're working in the health care sector, but HIPAA, in fact, does give an exemption to public health, so--providing information from the clinical sector to the public health sector for public health purposes and says in that situation it is OK to transfer identifying information. Mr. Murphy. Well, I certainly hope as all this is gathered a great deal of training information is available to physicians, hospitals, emergency responders, police, etc., because a lot of them still don't know what to do. And let me ask one final quick question. Who is ultimately in charge when a disease outbreak is determined? Who is the top of the chain of command? Dr. Fleming. Well, the President, obviously. Mr. Murphy. I mean, is it where the thing occurs first? Oftentimes first responders, whoever's first on the scene in that community, is now in charge either nationwide, or it begins in some State---- Dr. Fleming. I'm sorry. I misunderstood your question. Health is a State's right, and so it will be the State health department at which there is legal jurisdiction for the health events going on in the State. If an event crosses State boundaries, then it becomes also from a legal perspective a Federal jurisdiction issue. Mr. Murphy. And so such actions as quarantining, other information then becomes through--Health and Human Services, HHS and CDC begin to take control and begin to tell States what they should do in communities and travel, etc? Dr. Fleming. The short answer is yes. The more accurate answer is that we really do have a good partnership in public health, and so CDC and State and local health departments routinely, every day, in the absence of who is in charge, make critically important decisions about what needs to be done. Mr. Murphy. Thank you. Thank you, Mr. Chairman. Mr. Shays. I thank the gentleman. In our two panels we have the national looking at the civilian and the military, and then we have basically State and local and international, and we're also looking at the private in our second panel. I was just curious, Dr. Tornberg, as you're hearing the questions being asked to Dr. Fleming, besides thinking what you're going to do this evening or tomorrow or on the weekend as it related to this hearing, what kinds of things go through your thoughts? I'm just trying to figure out how you interface with CDC. Dr. Tornberg. Well, we interact extensively with CDC and I have with Dr. Fleming on issues. The collaboration extends not only to CDC, but to a host of other Federal agencies and the World Health Organization. As I indicated in my earlier statement, we have representatives assigned to CDC, military epidemiologists. We are currently assigning an individual to represent--Dr. Winkenwerder--at the--to Dr. Gerberding's office as we speak. So the collaboration is very close, and there's an ongoing active discussion. Particularly with the SARS outbreak, there's been really intense collaboration between CDC and the World Health Organization and our assets, the assets of DOD-GEIS, in addressing this issue, and I think we have a really fine working relationship. Mr. Shays. Now, if there wasn't the terrorist threat, you'd still be in business, and why would that be true? In other words, if you never had to worry or--not just the terrorist threat, but a sanctioned military effort on the part of an adversary to use biological agents, if you didn't have that concern, whether it was sanctioned by a government or individual terrorist attack, one used against the military or one used against civilians, would you still be in business, and why? Dr. Tornberg. Yes, sir, we would be. In fact, our ongoing efforts and our fight to preserve the health and safety of our personnel demands that we be very active and proactive in this arena, as we have been from the earliest days of the Department of Defense. Our forces are expeditionary in nature and exposed to a host of---- Mr. Shays. I get the gist of that. Thank you. That's clear to me. Let me ask you, Dr. Fleming, though, so you have Dr. Tornberg, who's focused on a national and international, tell me how your focus becomes international in terms of the fear-- in other words, we have representatives from our military all around the world. Is your focus international as well as national? Dr. Fleming. Absolutely. And it is for several reasons. The spector of infectious disease is perhaps the most obvious threat. A case of drug-resistant tuberculosis or SARS is simply a plane ride away in today's world. And one of the best ways to prevent the emergence of both known and unknown diseases in this country is to make sure that we have a strong global network and a U.S. presence, a CDC presence, overseas fighting those diseases in the countries that they're occurring, minimizing the chance that they will come here. Mr. Shays. How many laboratories would CDC have overseas? Dr. Fleming. CDC's primary expertise is in people and epidemiologists, so we have a handful of field stations, but in my opinion, the real international resource, the resource that CDC provides for the world, is in the trained epidemiologists, and we currently have approximately 60 CDC medical epidemiologist in various countries working with local ministries of health on critically important issues, be it polio eradication, or HIV prevention, or surveillance for infectious diseases. Mr. Shays. Dr. Tornberg, how many--is that classified information? Dr. Tornberg. No, sir, it's not. We have five overseas laboratories. Mr. Shays. And where are they located? Dr. Tornberg. We have a laboratory in Thailand, in Jakarta, Indonesia. We have one in Peru, Kenya and Cairo. Mr. Shays. OK. Now, getting to where Mr. Bell is, in Congress, we have to wrestle with a constituent who will say we need to do this, and they want a State law because they don't like what their--they want a Federal law because they don't like what their State is doing, and we get into this issue of, you know, do we overrule State law and have a uniform law. And I try explain that you sometimes can end up with a common denominator, and you might want a stronger law in one State versus another. But when you get into health care and you get into this issue of collecting data, I'm really unclear as to what restraints there are. I mean, is there an untold story here that Republicans don't want to get into this because there is the States rights issue, and Democrats may not want to get into this because of the personal privacy? I mean, is party ideology, conservative or liberal, getting into play here besides the issue of resources and people-dependent and money, because I'm thinking, good grief, we're not going to have a vaccine for every potential pathogen, every potential illness inflicted on us. So one of the ways that we are going to deal-- and we wouldn't want to necessarily even if we could, because there's always some side effects with that. So we want to--it seems to me our strategy is identify quickly, isolate it, contain it, and deal with that as we find it. And I'm unclear from you, Dr. Fleming, as to, you know, are we going here and there, or are we just trying to say, well, given this disparate kind of system we have, we'll make the best of it? Or should we say this is absurd, this is ridiculous, we want to have unified information, we want to have every local community send it up to the State on real time, we want it available to the Federal Government on real time, just like K-Mart might know what they have in their inventory and what they sold in the last 15 minutes? In my mind, that's kind of the way I'm thinking, but I'm not sensing that's the way the Federal Government's thinking. Dr. Fleming. First off, I think--just so that you'll know, I have about 20 years experience. Most of that is actually working at the State level. I have been at CDC for about 3 years, and so I have a little bit of history here. And I think if you'd asked me this question 20 years ago, I would have said you're absolutely right, because I would think that the rate- limiting step is the fact that people don't want to work with each other, and we can do it more quickly if we mandate it. That has changed dramatically, particularly in the last couple of years, such that there is now essentially uniform agreement that what the vision you just articulated is where we need to be heading. So the rate-limiting step isn't that people don't agree to that, the rate-limiting step is getting there through resources and planning and people, as we've talked about. Mr. Shays. And you said we don't need a law. You said CDC has the power to mandate a standard form, standard information. Do you have the capability under law to say we want it within an hour of your knowing, etc? Dr. Fleming. I'm sorry, I may have misunderstood your question. When I said we don't need a law, it is not because we have the authority to mandate it, but rather because it's my perception that it doesn't need to be mandated; that the system out there agrees with the vision and is trying to move toward it. We don't need the stick in this instance to get people where they need to be. They are there on their own. There is so much logic to it, and now there's now the information technology that enables it to happen, that with more and more people working at the State and local level, seeing the need for cross-jurisdiction communication and coordination, there is essentially uniform agreement out there that this is the way we need to go. Mr. Shays. If it's not a law requiring it, and someone doesn't provide it, then is there any liability? Dr. Fleming. Well, first off, in individual States, as you know, there are laws that mandate the provision of this information, and those are enforced generally through the licensure acts so that an agency or a laboratory that does not submit required information can be acted upon through their licensure. So there is a governmental stick, if you will. I'm just saying I don't see the need for a Federal stick. Mr. Shays. Let me go through just--you said our surveillance--on page 2 of the statement I had--it was 3 on another one, so I guess a different copy--but it said our surveillance systems generally use paper facsimile reporting by health care providers to health--if a case of illness is particularly unusual or severe, such as in the case of anthrax or rabies, the provider may call the local health department immediately. You had the word ``may,'' which I think is interesting. Then you say, as mentioned, health care provider recognition of the illness and awareness that certain health events require immediate notification of public health authorities is critical to our ability to detect problems and mount a public health response. Such reporting requirements are mandated at the State level. But aren't they mandated in different ways, different timeframes, etc? Dr. Fleming. There is currently some State-to-State variability around the specific conditions and the timing. I think my experience has been that the right things are happening, though, so regardless of whether you say a case of anthrax should be reported immediately in one State or within an hour in another State, if you look across States, the bottom-line message is the same, is that there is a common list of conditions for which immediate action is warranted, and then another category of diseases for which you can have a little bit more time to do the steps. I'm not trying to make it sound like it is a perfect world out there. What I am saying, though, is that tremendous progress has been made such that, at least in my opinion---- Mr. Shays. You know, I agree with the tremendous progress, and I do think that if you can get things to happen voluntary-- and I'm going to just roll my 5 minutes over and start a second round of just 5 minutes, if I could. So I'm going to begin the second round of questioning. I guess this is what I'm wrestling with. I kind of have been listening to Representative Bell, and I'm thinking, as he's asking these questions, we are safer than we were before September 11, but we don't feel as safe because we had a false sense of safety before September 11. But we've had--you know, SARS is an interesting kind of process here that just kind of makes us alert to the fact that both of you are dealing with defense against the pathogens that may attack us. You know, for the nonscientist, me, the nondoctor, me, when I hear there are mutations of SARS, and you think, you know, this thing is like an interesting threat to say the least, I'm just wondering, what in the world it is going to look like in a year or two? Will Mr. Bell or Mr. Janklow or Mr. Murphy and I be able to say a year from now when there is an outbreak, one--excuse me--if there is an illness in one place and an illness in another place and an illness somewhere else, and they don't see the severity of it, but if you put it all together, we would see it clustered, will we know within an hour of that, or will we know 5 days later? And if one or two States don't have the same requirements, will it be incomplete information? Or are we going to have a good system in a year from now? That's kind of what I'm asking. And I'd like, Dr. Tornberg, even though this isn't your direct responsibility because it's CDC, I want you to tell me what you think is going to happen, and then I want you, Dr. Fleming, to tell me what you think. Dr. Tornberg. I think we are moving clearly in the direction that you described. Will that be a year from now? Difficult to say. But the recognition time of a syndromic event is really somewhat based on the kinetics of the event itself and how rapidly it travels. But we clearly are moving in that direction and would hopefully have that capability and make this a much safer place. Mr. Shays. What would be wrong for me to say that we should be able to say, all right, we will have it ready in a year, or we will have it ready--what is the puzzlement that says that we won't? I mean, what--if everybody realizes we should have it, why are we talking this way? Dr. Tornberg. Well, what we are gaining in part of the growth phase--and we are in--with syndromic surveillance itself, and that's what we're talking about, we are in the toddler stage, if you will, in the development and the maturation of the process, and it's clearly a process that has to mature from a--data acquisition is part of the problem, but a bigger part of the problem is the analysis of the data we have, because there's, as we discussed, many disparate sources of information, and there can be data overload. The key in the challenge is to analyze that data to allow it to be--have a meaningful pattern, and subsequently to allow us to---- Mr. Shays. You're telling me that it is going to be very difficult, and it is just not going to be adding numbers. I hear you. Dr. Tornberg. We can't identify aberrations if we don't know our baseline. That's critical for early detection. And we are very much right now in the phase of developing our baselines and noting exceptions from that. Mr. Shays. Well, basically I'm just trying to make--this is kind of like telling me we have a learning curve? Dr. Tornberg. Yes, sir. Mr. Shays. OK. And you're not able to tell me how long that learning curve is going to take. Dr. Tornberg. I would be hard pressed to give you a year timeframe on that, but certainly within several years. Mr. Shays. Dr. Fleming. Dr. Fleming. In some ways I don't think it is a yes/no answer either. We have already around the country a system that works and that does identify these events. It does need to be improved, but how long that takes depends on what level of improvement and what we are trying to get to. A year from now our system will be better than the system we currently have today, and if we at CDC are doing our job right, 2 years from now it'll be better than the system a year from now. Mr. Shays. OK. Let me just real quickly, in the 40 seconds I have left, have you explain to me what would be a good system, a really good system. In other words, is the analogy of a K-Mart being able to tell me what's in their inventory, what's sold in the last--real time, is that just totally unrealistic? Dr. Fleming. Absolutely not. Real time is an aspect of this. But the true measure of a system is how responsive it is not in detecting the event, but in responding to the event and putting the actions in place that need to be put there to keep people healthy. And so my definition of the perfect system, if you will, is a system that is rapid enough such that the preventive actions that need to be put in place will happen before individuals become sick or die. Mr. Shays. Thank you. Mr. Bell, do you have any questions you want to ask? Mr. Bell. Can we do another round? Mr. Shays. Yes, another 5 minutes, and then we're going to---- Mr. Bell. Thank you, Mr. Chairman. I'm curious, Dr. Fleming, because in your original statement you said that there are reports, or your--I believe it was your strong-held belief that there are reports that are not completed or acted upon. Dr. Fleming. That's correct. The system we have is not yet perfect. It works, it's good, but it can be improved. Mr. Bell. But let's say someone in Texas sees a case of SARS and decides not to, for whatever reason. Probably wouldn't be true today, but several--a couple of months ago--and chooses not to report that. Then certainly it would be your strong desire that they would report it, but if they didn't, there's absolutely no law in place to punish that individual in any way, shape or form, correct? Dr. Fleming. Certainly within the State of Texas, providers are licensed and are required by law to report. Mr. Bell. To you. Dr. Fleming. No, to the State health department. Mr. Bell. OK. And so--good. That's helpful. Where is the breakdown coming in the reporting mechanism then? Dr. Fleming. There are several places. First off, I think not everybody that's sick sees a doctor, so there's illnesses out there that may never be diagnosed. Second, some of the diagnoses that happen are--happen in such a way that the provider forgets to report. It is just--you know, it's not a willful act, but it just doesn't happen. The NEDSS system that we're putting in place, which basically says when a provider, clinician or a laboratory, as part of their clinical records, indicate they have just diagnosed this case of salmonella or E. Coli or whatever it is, they don't have to report it to the health department at that point. The computer system automatically recognizes it as a condition that requires reporting and automatically instantaneously transports it to the health department. That's a big part of the fix of the system. The third part is to make sure that when that report is received, that there's somebody at the health department to look at it and to investigate it. The bioterrorism resources that have been made available go a ways in making that happen. Mr. Bell. As the chairman alluded to, what would be--I'm just curious. What do you all see as the downside to having some sort of law that would mandate reporting to have that in place? Dr. Fleming. Well, first, I do think that there are different diseases that are of greater or lesser importance in different parts of the country. And so, for example, some of the fungal diseases that are common in the Southwest need to be reported there, but because they're not prevalent in other parts of the country don't need to be reported there. There is need and room for local flexibility. In addition, within the confines of a system that's trying to accomplish these agreed- upon goals, there is some flexibility about the best way to get things done. And in one--in all aspects of the government, the thing that will work best in one part or one jurisdiction isn't necessarily the thing that'll work as well in another. So we need to allow, in my opinion, for local flexibility around the process so that the agreed-upon outcomes that we're striving for can be achieved as best as possible. Mr. Bell. And one final question. It would appear, going back also to the--if we can get there in 1 year, it would appear that would be somewhat impossible. We don't know how much--as far as having one unified system, we don't know how much that would cost as we sit here today. You said you'll get back to us on that. If that price figure comes back, and it's obvious with the money that is presently allotted there's no way to get there, or do you all plan to advocate for more funding to go toward a national surveillance system? Dr. Fleming. We will make it clear within the administration and to you what can be done for what level of resources, recognizing that it's you all's decision where the tradeoffs need to come from. Let me just make one other comment, if I might. I would hate for you to leave thinking that we're talking about only one system; there's only one thing that needs to be done. Public health surveillance, including infectious disease surveillance, is a system of systems. We're talking about one today. But clearly the vital records system in this country for looking at births and deaths; the systems that we have in place for figuring out who's been vaccinated and who isn't, vaccine registries; the system that on a real-time basis surveys people out there to find out what they know about SARS, etc., are also critically important parts of our surveillance. And so we need to be thinking about ensuring that the system of systems is as robust as possible, not focusing on only one element. Mr. Bell. Thank you, Mr. Chairman. Mr. Shays. I thank the gentleman. Mr. Janklow. Mr. Janklow. Thank you, Mr. Chairman. Dr. Fleming, I've got several questions. I'm going to try to be really quick with them. One, does DOD have a good--in the words of the chairman--a truly good system? Dr. Fleming. The ESSENCE system has promise. I mean, I would say it's in evaluation, so I can't tell you yet. Mr. Janklow. How long has it been in evaluation? Dr. Tornberg. ESSENCE II has been in operation, I believe, for the last 2 years. Mr. Janklow. Dr. Fleming, in your testimony you talk about several years ago you initiated development of the NEDSS System. How long does it take to develop a system? Aren't we talking about two things? One, we're talking about software; and, two, we're talking about baseline or the data for the information you're going to gather on the software and how it is going to be utilized, correct? Dr. Fleming. That is correct. Mr. Janklow. In terms of developing the software, when--how long did it take to do that? Dr. Fleming. The software development process takes about a year to 18 months, but you also need to have the standards, agreement on what that software needs to do, and in addition-- -- Mr. Janklow. Excuse me. I thought you had the standards, and you've already told people what they're going to be that they have to meet to come out of the system. Dr. Fleming. No. Right. But what I'm saying is those needed to have been developed, in essence, before software can be developed. Mr. Janklow. How long have they been out? Dr. Fleming. It's an iterative process. We started work on it several years ago, and they're still being refined. Mr. Janklow. Let me ask if I can, picking up on Mr. Bell's question from before, can you tell me what hasn't been done because you haven't had enough money? What hasn't been done? What's lagging? Dr. Fleming. There's two things. One is the capacity on the clinical laboratory side, to computerize and send their information. So even if a public health department is equipped to receive information, that information can't be received if it can't be sent on the clinical side. Mr. Janklow. Why do you think it can't be sent? What's holding that up? Dr. Fleming. There's a wide range of systems that are out there, and, in fact, some aspects of the health care system still aren't computerized. Mr. Janklow. Isn't that what we started out talking about today? Does that take a mandate to get that done? If we've still got some aspects of the health care system that aren't computerized, and if there are no mandates in place, how's it ever going to get there? Dr. Fleming. I was hearing the question about mandates relative to a mandate on the public health system from the Federal level relative to the State level. There's a separate question about the need for electronic medical records and the development of clinical standards to create those records. That's a bit beyond my domain of expertise, but it is an active part of this, active part of this process. Mr. Janklow. But, sir, aren't we--what--we're talking about a reporting basically, either a diagnosis or a symptom; isn't that correct? Dr. Fleming. It's actually a bit more complicated, when you think about the range of information that is being collected in the health care setting. Mr. Janklow. I understand. But when we're talking about looking at this from a national sense, aren't we really talking about, one, diagnoses that have been made, and, two, symptoms that would lead one to the conclusion someplace else as you gathered this from all over that there may be a problem that we need to look into? Dr. Fleming. I think you might hear from the clinical sector that they would want that system integrated into their overall way of doing business so that they did not have to go off just for this purpose to enter information. But rather it needs to be part of the therapy that's being given and the monitoring of the patient. Mr. Janklow. Doctor, if you had the money you needed, how long would it take to get a system in place? Dr. Fleming. Again, there is a working system in place. We do have the ability to detect these events. We can make substantial progress over the next year to 2 to 3 years, but I don't want to make it sound like it is an on/off---- Mr. Janklow. Are people like me then unnecessarily concerned that we don't have a coordinated system in place? Dr. Fleming. I think that I've tried to express the level of concern we have, which is we see that this is important, and substantial progress has been made. The system is working. We can make it better. It's not broken, but it can be improved. Mr. Janklow. In terms of improving it, are we where we need to be in a world that deals with terrorism focused toward us? Dr. Fleming. That's the critically important question we need to address, as we've been talking about. There are things that can and do need to be done to improve our security. Mr. Janklow. Is that a yes or a no, sir? Dr. Fleming. Ask your question again, please. Mr. Janklow. Pardon? Dr. Fleming. Ask your question again. Mr. Janklow. In terms of the world that we live in where terrorism is directed toward us, are we where we need to be? Dr. Fleming. No. Mr. Janklow. OK. Thank you. Mr. Shays. Let me just--before we go to our next panel, this is Emerging Infectious Diseases. I think it is a peer review journal tracking and analysis disease trends, and it's done by the CDC; is that right? In the first article it has Planning Against Biological Terrorism: Lessons From Outbreak Investigations. Is this an article you're familiar with at all? Dr. Fleming. I've not looked at it. Mr. Shays. In the first paragraph it says, for six outbreaks in which intentional contamination was possible, reporting was delayed for up to 26 days. We confirm that the most critical component for bioterrorism outbreaks detection reporting is the frontline health care professional and the local health departments. Bottom line, though, it--you know, I'm going to take a better look at this article. Well, actually I have to take a look at it. I haven't looked at it other than that quote. But you can't respond to that issue of---- Dr. Fleming. I would also need to review the article to respond in detail. Mr. Shays. Well, why don't we just submit it for the record then. [The information referred to follows:] [GRAPHIC] [TIFF OMITTED] 89547.027 [GRAPHIC] [TIFF OMITTED] 89547.028 [GRAPHIC] [TIFF OMITTED] 89547.029 [GRAPHIC] [TIFF OMITTED] 89547.030 [GRAPHIC] [TIFF OMITTED] 89547.031 Mr. Shays. You both have been wonderful witnesses, and we realize we're also wrestling with this. I think that what I am wrestling with is that I see this as the whole package. So when you talk about your not being able to talk about the technology to present this, you know, rather than its--you know, some of these are paper transactions. For me, I don't really--I don't like the feeling that I'm getting that we're not--I guess what I'm beginning to think is who's in charge? I don't mean that in a disparaging way, but who is taking ownership of this? Ultimately who takes ownership of making sure that this reporting happens quickly, that it's not paper transactions, that we're asking for the right things? Who ultimately, in your judgment, has that responsibility? Dr. Fleming. Well, the short answer is that CDC can and is taking a leadership role in this, and if I haven't conveyed that clearly, I sincerely apologize. I want you to know that our organization is committed to making this happen. Mr. Shays. I get a feeling that you're content that a lot of progress is being made. And maybe what I'm hearing as well is that from a scientific standpoint, you know, we just--we study it, we check it, and we just--and so it'll happen when it happens. That's kind of the feeling, that we're making progress, but that's the kind of feeling I'm getting. From a politician and public policy standpoint, I'm thinking should we be tasking you to just make sure in a year or two it's done. And then you're probably saying, hello. You know, what do you mean it's done? So the process begins, you know, continues here. Any last comment that you'd like to make before--OK. You both have been excellent witnesses, and I thank you. Excuse me. Let me just say this. Is there anything, Dr. Tornberg or Dr. Fleming, that you want to put on the public record before we adjourn? A question maybe you had prepared for that you think we should have asked, and we just didn't have the common sense to ask it? Dr. Tornberg. No, sir. I think both my oral and written statement cover the areas that we would like to address for the committee's attention. Mr. Shays. Dr. Fleming. Dr. Fleming. No. We will get back to you on the record on the issues that we talked about. Mr. Shays. OK. And on this article. Dr. Fleming. Yes. Mr. Shays. OK. Thank you both very much. Let me just announce the second panel. I'm going to ask three people to come up to be sworn in: Ms. Mary Selecky, Dr. Seth L. Foldy, and Ms. Karen Ignagni. And then afterwards I'll invite Dr. Julie Hall to sit down at the desk as well. We're swearing in three of our four witnesses. [Witnesses sworn.] Mr. Shays. And at this time we'll also invite Dr. Julie Hall, medical officer of the World Health Organization, to join us. Evidently we didn't make it clear to the World Health Organization we swear our witnesses in, and they have a policy as an international agency not to be sworn in. So we'll accept the way it is. And Ms. Selecky is Secretary, Washington State Department of Health, president of the Association of State and Territorial Health Officials. Dr. Seth L. Foldy--am I saying it right? Dr. Foldy. Foldy. Mr. Shays. Foldy--commissioner of health, city of Milwaukee; Chair, National Association of County and City Health Officials, Information Technology Committee. And Ms. Karen Ignagni is president and CEO of American Association of Health Plans. And Dr. Julie Hall, as I said, is medical officer of the World Health Organization. We'll go in the order that you're sitting. And again, 5 and then another 5. Your testimony is very important to us. And I think that I would say that if you want to ad lib a bit, and given that you sat through this first panel, that you may want to jump in and make some points, because I think some of the questions we've asked you you're well prepared to answer. So we'll start with you, Ms. Selecky. STATEMENTS OF MARY C. SELECKY, SECRETARY, WASHINGTON STATE DEPARTMENT OF HEALTH, PRESIDENT, THE ASSOCIATION OF STATE AND TERRITORIAL HEALTH OFFICIALS; SETH L. FOLDY, COMMISSIONER, MEDICAL DIRECTOR, CITY OF MILWAUKEE, HEALTH COMMISSIONER, CHAIR, NATIONAL ASSOCIATION OF COUNTY AND CITY HEALTH OFFICIALS, INFORMATION TECHNOLOGY COMMITTEE; KAREN IGNAGNI, PRESIDENT AND CEO, AMERICAN ASSOCIATION OF HEALTH PLANS; AND JULIE HALL, MEDICAL OFFICER, WORLD HEALTH ORGANIZATION Ms. Selecky. Thank you, Mr. Chairman, distinguished---- Mr. Shays. Is your mic on? Ms. Selecky. Thank you, Mr. Chairman and distinguished members of the subcommittee. My name is Mary Selecky. I'm the Secretary of Health in Washington State, and I'm honored to be testifying before you today as president of the Association of State and Territorial Health Officials. And also having been a local health department director for 20 years and having the experience of, on the ground, working local, State and working with our Federal colleagues, we certainly can address some of the issues that came up earlier. I certainly would like to thank the committee for your past support of work that goes on with public health, but most particularly your attention to the issue. It has not been in the recent past that we've had the opportunity to bring public health issues before you. This hearing focuses on one of our most important, although invisible and forgotten, public health tools, and that is public health surveillance. It's not something people think about every day. As early as 1878, Congress recognized that this is an important issue when it authorized the U.S. Marine Hospital Service to collect morbidity reports concerning cholera, smallpox, plague and yellow fever from U.S. Consuls overseas. Now the diseases may have changed, but the issues are very, very similar. In 1928, all States, the District of Columbia, Hawaii and Puerto Rico were participating in national surveillance and reporting on 29 diseases. And in 1950, ASTHO, my organization, created its affiliate, the Council of State and Territorial Epidemiologists [CSTE], to determine and work together, States, local and Federal, to see which diseases should be reported to the U.S. Public Health Service. All States now voluntarily provide information to the Centers for Disease Control and Prevention [CDC] on nationally notifiable diseases. One of the core functions of State health departments is to collect, analyze, interpret and disseminate public health data. States do this to identify health problems, determine the programs or other responses needed to address the problems, specific health concerns, and evaluate the effectiveness of the responses. Health departments depend upon the receipt of quality public health data to identify and track emerging infectious diseases such as already mentioned, SARS and West Nile virus. Equally important, although often overlooked, is the collection of public health surveillance data that identifies the burden and causes of the Nation's leading causes of death. That's chronic diseases, heart disease, diabetes, injury and risk factors. We may have more attention paid at times to communicable disease, but we must do the same with the noncommunicable. State health departments have a unique role to play in public health surveillance. Public health threats do not respect political boundaries, be it the local level or the State level. Reporting of disease entities, therefore, needs to be uniform within any given State in order to work with Federal and local colleagues to assure an adequate immediate response to public health emergencies. In many parts of the country, only the state Health Department has the sophisticated laboratory and highly trained laboratorians, epidemiologists and other public health professionals needed to tackle the most serious public health challenges. I had that personal experience. I was in northeast rural Washington, Colville, Washington, up in Representative George Nethercutt and formerly Speaker Tom Foley's district. We didn't have the levels of sophistication that perhaps our colleagues in Seattle did, and, in fact, Seattle might be very busy with the work going on with their own communicable diseases. Work we did from our rural community was dependent on our State colleagues helping us and opening the door, if needed, to the Federal kinds of resources available. In this testimony I'd like to make four points. Since the 1988 Institute of Medicine's Future of Public Health Report recognized the inadequacy of our public health infrastructure in general, and public health surveillance in particular, we've made great strides, and you have heard some of those. Substantial congressional investments in preparedness funding have enabled States and local to expand our surveillance capacities. We must continue our efforts to integrate and coordinate public health surveillance systems. You've already heard that. While tremendous efforts are focused on developing high- tech surveillance systems, and technology is critically important, a computer without the right software and without a trained user is just an expensive paperweight. We must proceed with caution and ensure that any new systems are tested by local and State health agencies and determined to be usable and effective. Despite the progress made since the Institute of Medicine report, much more needs to be done, and you've already heard some of that. We have a number of health professionals, and Dr. Fleming already mentioned that, that are due to retire in the next 5 years. We must pay attention to our work force. To illustrate my points about the importance of public health surveillance, I'll give you three quick examples from Washington State. SARS, in Washington State today we have 24 cases; 22 of those are suspected, 2 are probable. That's a fairly high number across the United States when you look at our map. The systems that we have in place now were dealing with rapid identification; using common case definitions; the reporting mechanisms we have in place from our local health departments, from our clinicians to our local health departments, to us at the State and us in real time to the Federal Government, so that we all got a handle on this. We've been able to use the systems that we have enhanced over our State's emergency preparedness efforts. West Nile virus. Washington State has not yet been hit with a human case occurring in our State. We know the mosquito is there. We've had dead birds. We've had dead horses. But for West Nile what we're doing right now is we're doing that real- time educating. We are using Webcast. We're using our information systems to enhance what people need to watch for, how to diagnose, how to report to our colleagues at the local level, and what it is we need to do as a State and work with the Federal Government at the Centers for Disease Control and Prevention [CDC]. And one other example is E. Coli O157:H7. Washington State unfortunately has a lot of practice. It was Burger King back in the early 1990's. It actually was a number of cases in 1985. Our public health lab created the 1-day test, what used to take 5 days, in Washington State. We were working together with the scientists at the Centers for Disease Control, because the real-time reporting, that happens through PulseNET, through our public health laboratory system, and then to capitalize on that with the National Electronic Disease Surveillance System really means that we deal with this very quickly. Last summer we had a multistate outbreak that had to do with a meat packer in Colorado. We worked very closely together with the systems that are in place to make sure the public is protected. In closing, I want to reiterate a few points. First, thank you to Congress for investments. They hadn't come in the near past. The investments have become more real more recently. They must be sustained. State and local public health working together with our partners at the Federal level need to have that investment. Second, public health work force issues must be addressed, whether it's through our schools of public health, whether it's through routine training available using, for example, Webcast satellite downlinks or whatever the case is. And the third is the continuing effort to coordinate the systems. A clinician and a local community is the first place where this starts, the local health department connectivity to that local clinician and to us at the State and at the Feds. Now, there are systems in place, and the reason you don't have a one-size-fits-all is the fact that you have had things develop; whether it's in Pittsburgh or an area of Texas, we've got to have common standards so that we can report commonly. Again, thank you for the opportunity to be here, and I'd be happy to answer questions when we're done with the panel. Mr. Shays. Thank you Ms. Selecky. [The prepared statement of Ms. Selecky follows:] [GRAPHIC] [TIFF OMITTED] 89547.032 [GRAPHIC] [TIFF OMITTED] 89547.033 [GRAPHIC] [TIFF OMITTED] 89547.034 [GRAPHIC] [TIFF OMITTED] 89547.035 [GRAPHIC] [TIFF OMITTED] 89547.036 [GRAPHIC] [TIFF OMITTED] 89547.037 [GRAPHIC] [TIFF OMITTED] 89547.038 Mr. Shays. And Dr. Foldy. Dr. Foldy. Yes. Good afternoon, Mr. Chairman, members of the subcommittee. I'm Seth Foldy, health commissioner of the city of Milwaukee, WI, and I speak today on behalf of the National Association of County and City Health Officials, which represents the Nation's nearly 3,000 local public health agencies. I'm glad to share a local perspective with you regarding the urgent need to support and to upgrade America's disease surveillance capabilities. I share your urgency. I certainly hear it. My remarks will be tailored considerably, given the advanced level of discussion you've already achieved previously. I believe I understand some of the sources of your impatience and some of your confusion about how to proceed. I would be remiss not to begin by just pointing out that the reporting of diseases to public health is but one part of the surveillance network and the surveillance resources that are greatly needed. Among those, of course, are resources for global surveillance, such as WHO has provided. I shudder to think what SARS would have been like in the United States without the advanced warning, or ``heads up,'' from the World Health Organization and the critical importance of the public health laboratory in permitting public health to speedily confirm what might be an epidemiologic suspicion. We have heard it often from Washington out in the hustings; we have heard it asked, ``Does the United States have the ability to fight two wars simultaneously?'' And perhaps the most important--more important--and cogent question is ``Do we have the ability to fight two, three or four epidemics simultaneously?'' In the last few weeks, severe acute respiratory syndrome [SARS], has been added to the plate of local health departments not through--who do not have different divisions to deal with each of these problems, but it is one team typically who are all struggling with smallpox vaccination, West Nile Virus, influenza season--on its way out, we hope--resurgent HIV and AIDS and sexually transmitted infections, and increasing rates of obesity, diabetes and asthma. It is important for the committee to understand that the local health departments are the eyes and ears for surveillance of the Nation. They are also the hands and feet for the emergency public health response. Without the local public health agencies being a true part of the picture, we have a giant public health entity without eyes, ears, hands or feet. However, the local public health agency is at the bottom of the funding chain, often at a low priority for local tax dollars, and, very importantly, many are now downsizing during the current fiscal crisis. You need to be aware of this. Also, because the authority for communicable disease reporting really derives in common law from local police powers and nuisance enforcement, there is typically no extrinsic funding or little extrinsic funding for disease surveillance at the local level, the most fundamental process that you are speaking about today. We thank you very much for soliciting the local public health view from NACCHO. The international SARS epidemic has clearly underscored the importance of disease surveillance, and you can just look at how everyone at USA Today is trying to learn how to read an epi curve. It also underscores the importance of having integrated and flexible disease surveillance, and it points out weaknesses of our current system and opportunities for improvement. In terms of integration, Milwaukee began enhancing disease surveillance systems long before we were worried about bioterrorism. It really dates back to a massive outbreak of a common but then little known bug called Cryptosporidium. This waterborne outbreak sickened more than 400,000 people suddenly in our city. We had little idea that an outbreak was taking place. Traditional surveillance systems would not report a disease that was not mandated for legal reporting. Similarly, a spate of deaths during the 1995 heat outbreak makes it clear that it was also under the radar of health surveillance systems. This makes it clear that health surveillance can't be designed for one problem in isolation of others, and in particular, that very finely defined health surveillance systems that might be applicable for the agents we think are going to be responsible for a bioterrorism attack will really not serve us well. We need integrated systems that bring together information of various types, various diseases that are integrated in the public health world and not set up as some separate entity, some separate department of government. In terms of flexibility, you're going to hear in my presentation that ideas and innovations are bubbling up as well as down, and the creation of very highly standardized systems is important. What we really hope to achieve, I think, in our Nation today are standardized methods of coding information and standardized ways of transmitting information that--such that the information can talk to itself, and agencies and information systems can talk to each other in such a way that it actually encourages innovation. What is important is if you were, for example, to ask the Federal Government to mandate that all health care providers begin to report certain information immediately up at the Federal level, and that all local health providers and State departments do the same, the easiest way to do that is to create a single Web-based entry system where we all spend all of our time filling in the blanks on the instrument that has been provided from above. But what that denies us the opportunity to do is to create flexible instruments we carry into the field that, because of standard transmission of health care information, can then up link to the Federal system. That is a decision, an important decision, that has to be made, and yet I agree with you. We cannot dilly dally too long in seeking the right balance between mandates and innovation. The weakness of the traditional reporting systems have been pointed out, although they remain absolutely crucial. They are slow. They often give us incomplete information. They rely on paper forms that often sit around in piles, which should surprise no one. Furthermore, it is increasingly being pressured by the fact that a laboratory specimen obtained in Milwaukee may well be analyzed in Atlanta or in Santa Cruz, and that information somehow has to find its way back to the doctor's office and subsequently to the local public health authority. I agree very much with Dr. Fleming's catalog of improvements in the traditional reporting system: educating the providers, improving our laboratory infrastructure, creating a 24/7 response. But, in addition to this, I think the real low- hanging fruit for the traditional disease surveillance system is electronic laboratory reporting. There are huge numbers of laboratories out there. If each of their laboratory information systems could report data in a standardized fashion so that it would find its way to and through the different health information systems that come between them and the local public health authority, this information could reach quickly, be routed to us, could automatically alert us, could be stored, displayed, analyzed, and tracked, greatly reducing the work of local public health. My colleague, Rex Archer in Kansas City, has established such electronic lab reporting with a large number of laboratories in Kansas City and has demonstrated increased timeliness of reporting, increased completeness of reporting, reduced time wasted. However, as with all surveillance and public health, we know that it also gives us more complete reporting. He is chasing a lot more disease than he ever knew about before, and that has its real implications. The real point here is that the standardization of electronic health information is really a critical step. HIPAA really created a basement, a foundation for doing this by creating accountability, about confidentiality, security, and mandating certain standardization; and we really need to let this take root. The second topic that has been discussed is enhanced or syndromic surveillance. We know that we can look at a lot of different patterns of illness such as symptoms in emergency departments, pharmacy dispensing, test orders. It is very important to recognize that this is a young science, easily oversold, hard to prove how well it works. However, it is very important that we begin to explore these capabilities. This will require again standardized health information, information that can flow electronically so that we are not adding constantly to the workload of busy health care providers. In addition, it requires connectedness; and I will tell you a brief story from Milwaukee. On their own initiative, because they needed it for their own reasons, all of the local emergency departments established a secure, live Internet site that told them when different emergency rooms were on divert status. When we learned about that this resource was in each of our emergency rooms, we politely asked access to the system and have used it since to post alerts to the emergency medicine community. My pager goes off when more than three emergency rooms at a time go on ambulance divert. I can draw down statistics to see why emergency rooms are going on diversion and what the temporal pattern is. And, most recently, we have solicited the emergency rooms to provide us with daily updates of certain types of diseases, not on an ongoing basis, because they don't have the labor to do this continuously, but on an as-needed emergency basis. We performed such surveillance for bioterrorism-like syndromes during the All-Star game last summer. But beginning with the SARS epidemic, given this experience, we were able within 3 days to have 13 emer- gency rooms in our community both screening their patients routinely for possible SARS-related symptoms and then providing us with daily counts of what they were seeing. Mr. Shays. Thank you, Dr. Foldy. [The prepared statement of Dr. Foldy follows:] [GRAPHIC] [TIFF OMITTED] 89547.039 [GRAPHIC] [TIFF OMITTED] 89547.040 [GRAPHIC] [TIFF OMITTED] 89547.041 [GRAPHIC] [TIFF OMITTED] 89547.042 [GRAPHIC] [TIFF OMITTED] 89547.043 [GRAPHIC] [TIFF OMITTED] 89547.044 [GRAPHIC] [TIFF OMITTED] 89547.045 [GRAPHIC] [TIFF OMITTED] 89547.046 Mr. Shays. Dr. Hall. Dr. Hall. I am Dr. Julie Hall. Mr. Shays. I am going to have you move it a little closer. Dr. Hall. OK. I am Dr. Julie Hall. I am a medical officer with the World Health Organization. I work in the headquarters in Geneva where I work as part of the Global Outbreak and Alert Response Team and have helped to coordinate the international response to SARS. Mr. Chairman, Congressman Bell and members of the subcommittee, on behalf of the World Health Organization and Dr. David Heymann, Executive Director for Communicable Diseases, thank you very much for the opportunity to brief you today on improving surveillance for infectious diseases at the global level and to brief you on the lessons that we are learning particularly with regards to SARS. Dr. David Heymann asked me to convey his regrets for not being able to be here in person today. I have submitted a written statement for use by the committee. At the back of that written statement there is several charts that I will refer to during my verbal testimony. As has already been mentioned before, the threat of infectious diseases, of emerging and reemerging diseases is an ever present threat. And the first slide at the back of the written testimony shows a map of the world and a number of the infectious diseases that have emerged or reemerged in the past 5 years. It doesn't, as you will note, show SARS on there. The threats of infectious diseases is indeed an issue of security. Infectious diseases have the potential to damage not just the health of the population but to cause social disruption, particularly when frontline staff or health care facilities are affected, as is the case with SARS, and also to cause economic damage, again something clearly evidenced with SARS. Our traditional defenses against infectious diseases cannot always be relied upon. National borders do not protect against the emergence of diseases. And the second slide at the back there will show very graphically how quickly, within days, SARS had spread from one hotel in Hong Kong to over eight different countries around the world. Anti-microbial drugs, one of our previous defenses against infectious diseases, are becoming increasingly ineffective as antibiotic resistance increases; and scientific advancements in the development and productions of vaccines cannot always keep up with the pace of change for infectious disease. So the emergence of an infectious disease in one part of the world is a threat to the entire world; and our key defense is early detection, early dissemination of that information, and early implementation of the protective measures that are required to stop the spread of disease. The aim of global surveillance then is to provide the world with a window of opportunity early in the course of the disease when it is possible to potentially control and eliminate that disease. Surveillance at the global level allows the compilation of data from different sources. This is particularly important when looking at the emergence of a new disease, because quite often it is a jigsaw puzzle. Piece A may come from one country, piece B in terms of information may come from another. Surveying the world and having surveillance at the global level allows these pieces to be put together, and in the case of SARS this was absolutely crucial. We knew with SARS that there was ongoing problems in Guangdong. This was in early February. We knew also that there were problems with H-5 influenza in Hong Kong. So when one single case occurred in Vietnam, we were alert to a potential problem of pandemic proportions. Surveillance at the global level also allows us to put out the early warnings that have been so effective in terms of controlling SARS, and it allows us to get a global picture to assess the need for further action, whether that be at global level in terms of producing travel advisories or at local level to provide international support to countries that are affected by the disease. How does global surveillance work? Well, it works in much the same way that you have heard how surveillance works at local level, at State level, and at national level. There are four key components: the gathering of information, the verification of that information, further assessment of that information, and then a response is mounted. And it is key that surveillance should not be seen as separate from response. The two things are interlinked and critically important. In terms of global surveillance, we have a number of systems in place at WHO to collect the information. The first and about a third of our information comes from the WHO system itself. WHO has a headquarters in Geneva. It also has six regional offices and 141 country offices, and this provides a great deal of information about the emergence and reemergence of diseases of potential international harm. In addition to that, Health Canada runs the global public health information network that constantly scans nearly 1,000 media feeds and electronic discussion groups to look for hints of the emergence of diseases; and this gives us real-time and very accurate information of what is going on all around the world. Another key source of information for us is through the Global Outbreak Alert and Response Network. This is a network of over 150 different organizations from around the world-- laboratories, epidemiology groups, other health institutions; and, again, this can provide key early information. However, much of the information that's received at WHO comes in the form of rumor, and this must be verified. WHO is in a good position to be able to do this with its 141 country offices and regional offices who work quickly with local health authorities to verify information that has been provided to us. This can allow rapid confirmation that an outbreak is occurring and the ability to share information, but it can also provide rapid ability to refute information and clarify the situation, and that can ensure that panic does not ensue unnecessarily and economic damage does not occur. On a daily basis, the information that is received by WHO is assessed in terms of its risk for international health concern; and additional information such as geographical, political, and other social information is included as part of that process. Responses can be mounted very rapidly by WHO, and within 24 hours we are able to get field teams into virtually any country around the world. We are also able to disseminate the information very quickly through our cascade of country offices, through the production of information on our web, and other sources of information. If assistance is required by any country, any member state of WHO, this can be coordinated by WHO and with its headquarters and assisted by regional offices and the country offices itself. Expertise and field teams can be quickly organized, as I mentioned before, by calling upon our partners within the Global Outbreak Alert and Response Network of who CDC is a key player. WHO's neutrality and ability to get laissez-passer status to any member of our international team means that we have privileged access to 192 countries around the world. The fourth slide at the back of my written presentation gives an overview of the extent to which WHO and the activities at WHO has been coordinating in response to SARS. This included not just operational support in terms of field teams in Hong Kong, Vietnam, Singapore, Beijing, and now to be in Taiwan as well, the production of supplies and the creation of logistic bases in Vietnam, Thailand, Manila, and rapid response capabilities in Geneva, but it is also being--a considerable amount of energy and effort has gone into international collaboration, laboratory collaboration. Twelve laboratories around the world have collaborated to identify the virus in record time, clinical collaboration to share information, epidemiological and environmental collaboration as well. WHO has produced recommendations for the control of the disease, management of the patients, and prevention of international spread. However, there are areas for development, and these fall into two areas. Developments are needed in terms of capacity and developments in terms of commitment. In terms of capacity, global surveillance will only be as good as the national surveillance systems that it depends upon; and, as you can see in the final slide that's attached to the written statement, in terms of FluNet and other surveillance systems, there are clear holes in many countries around the world that need to be supported and developed if we are to have a truly global system. We also need commitment to global reporting, transparency, and commitment to global collaboration, for these are the key things that will defend us against infectious diseases. The true cost of SARS will be if we don't learn the lessons of SARS; and the true benefits that we have seen from SARS and the lessons that we have learned are that rapid detection, rapid implementation of protective measurements and also multilateral global collaboration can protect us from infectious diseases. Mr. Shays. Thank you very much. [The prepared statement of Dr. Hall follows:] [GRAPHIC] [TIFF OMITTED] 89547.047 [GRAPHIC] [TIFF OMITTED] 89547.048 [GRAPHIC] [TIFF OMITTED] 89547.049 [GRAPHIC] [TIFF OMITTED] 89547.050 [GRAPHIC] [TIFF OMITTED] 89547.051 [GRAPHIC] [TIFF OMITTED] 89547.052 [GRAPHIC] [TIFF OMITTED] 89547.053 [GRAPHIC] [TIFF OMITTED] 89547.054 [GRAPHIC] [TIFF OMITTED] 89547.055 [GRAPHIC] [TIFF OMITTED] 89547.056 [GRAPHIC] [TIFF OMITTED] 89547.057 [GRAPHIC] [TIFF OMITTED] 89547.058 [GRAPHIC] [TIFF OMITTED] 89547.059 [GRAPHIC] [TIFF OMITTED] 89547.060 [GRAPHIC] [TIFF OMITTED] 89547.061 [GRAPHIC] [TIFF OMITTED] 89547.062 [GRAPHIC] [TIFF OMITTED] 89547.063 Mr. Shays. I'm just going to say to our last witness that sometimes when I have discussions with my staff I am right and sometimes they are right. They think they are right more often. You can be a really major player here. I say I pronounce your name Ignagni, and one of my staff says it's Ignagni. Who is right? Ms. Ignagni. Well, the Italian is Ignagni. So---- Mr. Shays. Neither of us are. Ms. Ignagni. The Anglicized version is Ignagni. Thank you, sir. Mr. Shays. Thank you. Ms. Ignagni. Mr. Chairman, thank you for the opportunity to testify. I want to commend you and the members of the subcommittee for taking this leadership. It is my pleasure and honor to be part of these distinguished panels, and I hope we might make some contribution to the endeavor of improving our Nation's homeland readiness. As you will see, our members have unique capacities to contribute to this readiness effort, and I am pleased to have the opportunity today to discuss those capabilities. What distinguishes us in the health plan arena, irrespective of plan model, insurance type, or what have you, are four characteristics: First, we are providing coverage to defined populations, and the meaning of that is that we can get a sense of statistical significance of symptoms and what they mean as a percentage of a particular universe. Second, we have real-time de-identified data that we are reporting into a system. I make that point because, in response to Mr. Murphy's question earlier about HIPPA and patient confidentiality, we have taken steps in our program to make sure that we are fully compliant with HIPPA; and I will describe that more fully in a moment. Third, we have case managers collecting information from patients that are going into the system. And, finally, we have rapid-response outbound calling technology, so, to the extent messages need to get quickly to patients, we have the ability to do that. What we are testing in our program, which is described fully in our testimony, is whether or not we can leverage these capabilities to strengthen the public health surveillance systems, which has generally depended upon passive collection of data. What you have been talking about throughout the afternoon is in fact collecting data once individuals go to emergency rooms, once they go to the hospitals, once public health gets ahold of those individuals in terms of collecting that information. There is often a gap between the time individuals have symptoms and the time they actually seek treatment. So we are trying to see whether or not we can contribute to the transition to real-time data collection. After the tragedy of September 11, our members began an intense process of discussing how we could contribute to the effort to improve homeland readiness. We realized these unique capabilities could lead us to making a substantial contribution. We spent a great deal of time collaborating among our medical directors who are on the ground providing health care services to large numbers of people throughout the country and collaborated with the CDC, with ASO, with the county organizations; and indeed, we put together a very large advisory committee, including with international representatives, to make sure that the design of this particular proposal is rigorous and effective. What we began with is a process that draws data from plans covering more than 20 million people in 50 States. Since we have begun, and we are only months into it now, several health plans in Texas have been added to the system, and we are in major discussions with national plans all around the country. But I wanted you to get a sense of where we start in terms of a baseline. Here is how it works. There are five steps. First, there is a criteria established; and I am pleased to tell you, in light of the discussion earlier, that we are in compliance with the NEDSS system, the CDC system. So that's the first thing. You know what you are looking for. Second, each night a computer program at the participating plans captures clinical encounters for the preceding 24 hours, and it meets those specific criteria. These aggregate--and I want to stress--de-identified data are reported to a research center at Harvard University. The research center has a program that contains specific thresholds for notifying public health of particular occurrences. Now, obviously, I'm oversimplifying in an effort to make this as clear as possible, but there are decision rules in this program that flag certain collections of symptoms. Fourth, an epidemiologist will then analyze any spikes in information to make sure that the computer program has worked as expected, that we are not overly sampling particular clusters of symptoms, etc.; and the epidemiologist then will coordinate the reporting of a specific disease or illness in geographic areas, the manifestation of those, to the appropriate public health agencies and departments. For example, if the epidemiologist gleans that there are five individuals in a particular geographic area with pneumonia, that might be in compliance with the threshold and that might indicate that is something that needs to be reported. So that would be basically the way the system works. The public health departments then, my colleagues on the panel, in receiving this information would make a decision as to whether or not that would engender further investigation. Do they need to have more information about particular patients and the symptoms that are occurring in particular geographic areas? The system has several important features, as you can see. Specific populations are being measured. It is done in real- time. The system can be modified to capture new symptoms. So it's very interactive, if you will, to the extent that--to the extent when SARS became something that was not anticipated when we designed the system, we are now in discussions with CDC in terms of moderating the system and modifying it so we can capture those symptoms as well. The data are already being collected, so we don't have to actually go out and collect new data. And then, finally, I do want to stress, because of the emphasis in the questioning earlier, that we are in full compliance with HIPPA confidentiality rules. Health plans have for a number of years been at the forefront of population-based care, and what we are trying to do is to take a leadership role in constructing a system that can be expanded, and we hope that we can make a significant contribution to our homeland readiness. We have a lot to learn. We think that we can contribute something important, something unique, and we are going to be working very, very closely in our advisory committee with representatives from the organizations who are represented very well on this panel to make sure that the design is adequate and we are doing what we need to do to make sure that we can add a new contribution to the important efforts that were already described this afternoon. Thank you, Mr. Chairman. Mr. Shays. Thank you. [The prepared statement of Ms. Ignagni follows:] [GRAPHIC] [TIFF OMITTED] 89547.064 [GRAPHIC] [TIFF OMITTED] 89547.065 [GRAPHIC] [TIFF OMITTED] 89547.066 [GRAPHIC] [TIFF OMITTED] 89547.067 [GRAPHIC] [TIFF OMITTED] 89547.068 [GRAPHIC] [TIFF OMITTED] 89547.069 [GRAPHIC] [TIFF OMITTED] 89547.070 [GRAPHIC] [TIFF OMITTED] 89547.071 [GRAPHIC] [TIFF OMITTED] 89547.072 Mr. Shays. Before asking Mr. Janklow to begin his questioning, I am just going to make an observation. I made the analogy of Kmart, and my counsel said the challenge is--I'm not sure I'm doing it justice. But it's if Kmart had to get a lot of mom and pop operations into their network, they might not be able to do it in real-time. And I thought that is very intuitive, I think. One of the things that I'm noticing with health care is that--I use the word stepchild as if stepchild is a bad thing, but not always getting the attention that it deserves. We did one major tabletop experience in Bridgeport, and the fire, the police, they all--there were weaknesses in the connection, but our local health care providers were really caught without communications, without resources, and so on. So maybe what I'm hearing from the panelists are, my gosh, this is where we were and this is where we are, so we have made such great progress. But I think, in terms of the consequence, if there was an induced terrorist activity planned, located in certain ways, that we wouldn't be happy with the results. So that's kind of where I'm--I'm kind of wrestling with this, because I feel like there is almost a sense of contentment on the part of our panelists because we have made a lot of progress. Mr. Bell. Mr. Chairman, Kmart also went bankrupt. So I don't know if that's really one that we want to be using. Mr. Shays. That was another one, but then my staff spared me that analogy since I was the one who brought it up. And I will just say, Ms. Ignagni, I gave you the opportunity to be right with the chairman, and you declined. Ms. Ignagni. But, sir, you swore me in. Mr. Shays. That's true, I did. What a good answer. You have the floor. Mr. Janklow. Mr. Chairman, thank you very much. You know, I've--the hearing today, Homeland Security: Improving Public Health Surveillance, you know, and I recognize that public health surveillance, adequately done, truly contributes to homeland security. But I want to focus my questions, if I can, to the war on terrorism, you know; and I realize that, with respect to West Nile and SARS and hepatitis and measles and mumps and rubella and polio and I mean all kinds of other reporting things, the system works pretty good. When I say pretty good, I am making that with a small P and a small G, because, Dr. Foldy, I couldn't agree more with you: Because we are a Nation of 1,700 different sovereigns all the time, nobody is going to tell me what to do. So we have thousands of people that feel that way, and so that's why some are in paperwork and some aren't even reporting, and I think it's far worse than some of our colleagues at CDC think it is. But I'm going to focus on homeland security, if I can. World War II from start to finish for us took 3\1/2\ years. How many years is it going to take for us to design a reporting system that will catch deliberate acts of terrorism? Because if the good Lord doesn't or nature spreads diseases around, there's a pattern that WHO, that the whole world can figure out rather quickly. It's when human beings are deliberately helping the process move that we have never really been tested, ever, as to whether or not we have the ability to deal with it. Doctor, let me ask you first. If 1993 were replicated in Milwaukee, you would be on top of it in literally minutes if not hours, if not minutes. Isn't that correct? Dr. Foldy. That's correct. Mr. Janklow. And I have to believe throughout this country there are processes all over. What does it take to get them together to come up with a system? And you are next, Ms. Selecky. Dr. Foldy. I have little doubt that a deliberate act of bioterrorism would be detected within days. We've done things like make sure doctors know what they are looking for, make sure labs can do---- Mr. Janklow. But I'm talking about process, sir. Dr. Foldy. But what we want to do is shorten that window to hours---- Mr. Janklow. Can it be done without mandating it in some form? And I don't know if States do it or counties do it, the Federal Government does it. But isn't it possible to really get from here to there in a--recognizing a world war, is it possible to get from here to there during the war without mandating something? Dr. Foldy. I'm sure there will be mandates. I would add to those mandates, helping the health care sector move from paper and pencil to electronic---- Mr. Janklow. Isn't that the most important thing? Dr. Foldy. The latter? Yes. Mr. Janklow. Yes, sir. Do you agree with that, Ms. Selecky, that the most important single criteria is how do we get from paper to electronics? Ms. Selecky. I would add a criteria that has to do with the knowledge base of the people who are using---- Mr. Janklow. I agree with that. I understand getting the right people and training them. I appreciate that. But is that--is there anything--let me put it this way. Is there anything more important than the ability to get it from paper to electronics? Ms. Selecky. When we think about the health care system in this State, in this Nation, you look at relying on a local clinician, whether they are in a community clinic or a private office, to get the word to a local health department. And---- Mr. Janklow. And that's under the normal system, the way nature spread diseases. Ms. Selecky. Well, even under a bioterrorism event. Actually, the city of Seattle and the city of Chicago this next week will be participating in TopOff2, the top officials exercise. I just spent my morning with the Federal Cabinet in preparation for the work that will go on. In Washington State it will be a radiological---- Mr. Janklow. Can I interrupt you for 1 second? You are getting prepared for that tabletop. When they hit you with terrorism, you're not going to have--you're not knowing it's coming, what day, what hour, and what teams to assemble. Ms. Selecky. No disagreement. And these aren't tabletops. We actually are doing exercising. And you are right, we do have information ahead of time. The point is, where are the flaws in the system or the weaknesses. Mr. Janklow. OK. Ms. Selecky. The learning from this is what's essential in that whether---- Mr. Janklow. Will that be shared with people all over the country? Ms. Selecky. Yes, the results of that will be. Yes. Mr. Janklow. OK. Ms. Selecky. In terms of the communicable disease, for example, that will be used in the Chicago venue--and it will be pneumonic plague--it's a matter of what systems are in place, are people reporting electronically now? No, not everywhere; and it will be as important in a rural area as it will be in an urban area. Mr. Janklow. Excuse me for a second. Ma'am, you look shocked. You are sitting there looking at me shocked. Is there a reason? Ms. Ignagni. Ms. Ignagni. Well, I didn't mean to interrupt. But you did read me correctly. And it's not shock. It's I think that there is something in addition to the electronic issue. But I would be happy to wait until our colleagues finish answering their question. But you registered my being perplexed as I was thinking about your question. I think there is something that we have been missing all afternoon, frankly. But I don't want to be rude and interrupt your---- Ms. Selecky. No. If you've got it, go for it. Ms. Ignagni. Well, no. I don't know if I have it. I wouldn't want to be presumptuous. I'm the only one on the panel that isn't a physician. But in my humble opinion, in looking at the reports by the Institutes of Medicine, the General Accounting Office, the World Health Organization reports, where we are going wrong in our country in terms of bioterrorism readiness is that for too long we have thought of the health care system as what happens in the hospital. Now that's a very important part of the health care system, but I can tell you that what we did--and we're just beginning our demonstration program. But we did a dry run in Massachusetts, and what we found is that people were reporting symptoms into our system a full 2 weeks before people ended up in the hospital. So, sir, when you asked the question is there something more important than electronic, I was sort of shaking my head and intuitively going through all this information. And I didn't want to sound presumptuous in sharing with the committee the idea that I do think the comments that have been made, particularly by the GAO about their reliance on passive reporting, is something that we really have to get our hands on and we have to figure out how do we go to real-time. It's not just about electronic, though. Mr. Janklow. If I could ask that the three of you from American organizations, and just whoever wants to answer first or only--be the only one, what do we need to do to fix this? If your children's lives depend on it, your neighbors' lives depen on it, is this a congressional fix? Is it a Presidential fix? It is a health community fix? I've heard people say that lawyers and judges can't fix what's wrong with the legal system, and that doctors and hospitals can't fix what's wrong with the medical system. It takes outsiders who have a different perspective, who are really not the producers but the consumers that contribute. Let me ask you. What does it take to fix this? Because we are all frustrated. Dr. Foldy. Well, until the information can flow rapidly, we are missing an essential part of the fix. Ms. Ignagni brings this up. The next point, which is do we really know--there is a lot of science that needs to be done and needs to be done ideally-- -- Mr. Janklow. You said--I think your quote was, young science easily oversold. Dr. Foldy. So, for example, she raises one of many very interesting and answerable questions: What part of the health system or other human behavior---- Mr. Janklow. OK. But, sir, how do we get there? Dr. Foldy [continuing]. Serves as an early detector. Mr. Janklow. We are in the third year of the war. How do we get there? How do we wind this up? Dr. Foldy. I would like to see a lot of the best people in Federal agencies, including the different agencies within the Centers for Disease Control, be given an office and some money and some contact with the best people in informatics, intelligence, Defense Department, even financial systems. I mean, I can draw cash out in Taiwan, but I can't see surveillance figures in my own den. And there is a lot that can be learned quickly if people can be brought together, apply sustained attention to the problem over the next few years, while having--starting to get the electronics information that---- Mr. Janklow. If I could ask you, sir, if you would just submit to the committee a list of who you think ought to be at that table by organization. Dr. Foldy. My local perspective, and therefore very imperfect perspective. Mr. Janklow. Sure. Dr. Foldy. Yes. Mr. Janklow. Ours is perfect, sir. Yours isn't. No, we understand that. In the most base sense, we all understand that. But if you would, because you can tell by our questions, all of us, we don't know what to do, but we don't think what's being done necessarily is working. If someone is going to attack us tomorrow, are we ready? The answer is, no, we are not if they are going to be spread around--if they were to spread this around. We have seen what hoof and mouth disease can do to Europe, to the livestock industry. I can't believe that something wouldn't be akin to human beings if they had the same type of disease for people. I know they do have that one, but I'm not talking about Banks disease. Thank you, Mr. Chairman. Mr. Shays. I would just point out, though, that's one form of terrorism; and that's not just the attacks on human beings but the attacks on livestock could be devastating. Mr. Bell, you have the floor. Mr. Bell. Thank you very much, Mr. Chairman. First of all, Dr. Shelley Hearne could not be here to testify today, and I would ask unanimous consent for her written testimony to be submitted for the record. Mr. Shays. Without objection. And she is with---- Mr. Bell. Trust for America's Health. Mr. Shays. Thank you. [The prepared statement of Dr. Hearne follows:] [GRAPHIC] [TIFF OMITTED] 89547.073 [GRAPHIC] [TIFF OMITTED] 89547.074 [GRAPHIC] [TIFF OMITTED] 89547.075 [GRAPHIC] [TIFF OMITTED] 89547.076 [GRAPHIC] [TIFF OMITTED] 89547.077 Mr. Bell. I want to go back for just a minute to this idea that was discussed with the previous panel of trying to create one unified system for reporting; and you all, I think, were all present during that testimony. I'm curious as to where you would rate the importance and if you are as troubled as I am by the fact that we at the present time don't know how much it would cost and really don't have any time line for getting there, and the amount of money being committed toward spending on that type of surveillance system is decreasing rather than increasing. And I will begin with you, Ms. Selecky. Ms. Selecky. As the other nonphysician on the panel and a person of great practicality, as many of us are, the issue is that we really don't have sort of a uniform system like you would call a Kmart, regardless of whether they went bankrupt or not. There are multiple plans, they're private and public, and having a one system fits all doesn't cut it in this country very often. That's why I think that you hear us talking about common standards so that the information that's collected can speak and give us the information that we need to take quick and rapid action. That's one. Two, I think that your colleague who was here earlier talked about a reporting system in southwestern Pennsylvania that's been under development, that works there, works under the State laws of the State of Pennsylvania, is a good model for many of us to look at as to whether it would work in Washington State or in other States, and learn the best things from it, as long as we all have the common format of reporting in a way to get the information again real. In Washington State, we still have very rural parts of the State that don't have Internet or electronic reliable capability, so that we do have to have redundant systems. And you would falsely rely on the ability for everybody to have access to T-1 lines, etc. We are not the only State like that. There are other rural States like that, also. Cell phones don't work in many places. Fax machines usually can be relied on. The Internet goes down when that backhoe digs up the one line to Ferry County or whatever the case is. So we have got to make sure that we continue to work on what the reality is. The reality is, are people informed at the closest level to where a client shows up with a symptom, be it at a doc's office, a clinic, or an ER--is that person informed to get that information to the folks who need to have it at the local level, as they see increasing activity get the information to the State level and we work together with the Feds? We would all like to have it done in that real-time, rapid way that allows us to rely on the electronics. But having experienced the earthquake in Washington State, we could not then rely on the electronics. We did have to rely on the person-to-person reporting. You've always got to have both of those things in place. So by virtue of the fact of making sure that what's in place now works, that you parallel, then grow it up, the infant system Seth talks about that needs to be developed across the Nation with common standards, that would be my goal. Mr. Bell. Dr. Foldy. Dr. Foldy. I think this was well summed up. I do sometimes--and I'm not a software engineer--but I do sometimes look at the way the Internet was able to develop. Nobody could figure out ever to design something that is like the Internet, but once people learned that they were going to--that they had the benefit of communicating through a few very simple standards so that it didn't matter what kind of computer you were on or what kind of browser you were using or anything else, the kind of capabilities that developed out of that were very great. So I have some hope for that. I do think that Ms. Selecky's points are very well taken about not overestimating the capability of the people in the field at either the State or the local level. I hasten to remind the committee that, prior to Congress creating specific health alert network funding that was earmarked to local health departments, the majority of health departments had no Internet connections in this country. We do have a severe backlog of information infrastructure and people development, bringing them along both in terms of skills, technical, epidemiological, and laboratory in our local health departments. It is not impossible--it is impossible to overlook that deficiency, because there is no State or national organization that has the people to fill in where local health departments need to play their role. So you are looking also at strengthening the infrastructure at the local level so that a lot of information isn't simply released that results in an inadequate response. Mr. Bell. Dr. Hall. Dr. Hall. I think the most important thing, as I said before, is about commitment and also about capacity. I think that the most important take-home message really is that a disease occurring anywhere in the world within hours can affect any other country around the world. And when we have a map that looks like this, the very back of the written statement, where we have great big holes in terms of surveillance around the world, then nowhere in the world, no matter how good their national reporting and surveillance system is, is going to be safe from the threat of infectious diseases. So I think it's about investing in capacity, both in the countries that already have some in terms of improving the capacity they have but key to it is investing in capacity in areas where there simply is nothing, where we would not be able to--it would take a very long time before we detected that a problem was emerging in that area. And it's about investing in the commitment to that and investing in the commitments of transparency in terms of reporting from all those countries and constantly building up capacity so that all around the world we at least have a basic minimum level so that we can find out exactly what's happening. Mr. Bell. And Ms. Ignagni. Ms. Ignagni. Thank you, Mr. Bell. We crossed this bridge as we were developing our demonstration program, and we would not have developed it without a consensus on what was being measured, how we were going to measure, and how we were going to retrieve data. It simply wouldn't provide anything that was useful. And that's caused me to listen to my colleagues, and I think the comments have been very, very thoughtful, and I largely agree with them. I do think, however, there is an opportunity to achieve uniformity in a productive way here without necessarily killing the innovation and the public health kinds of activities. You'd want to be nimble at the local level, and I think that's--if I could draw out what I heard--while at the same time having some consistency across different systems and States to measure, because we know that there are no geographic boundaries for infectious disease. Our community has committed to transparency. We are the only stakeholders in the health care arena measuring anything, which may surprise you in light of 5, 6 years of discussions about so-called patient protection. We are not measuring in any other areas. So for us, perhaps we crossed this bridge a long time ago, and we have consensus in our community about measuring. But I do think it's important now to think about drawing that out across the delivery system and particularly in this area. Mr. Bell. Ms. Selecky and Dr. Foldy, a number of national associations and organizations, one being the American Public Health Laboratory Association, have found that financing for many State health laboratories would be reduced this year and that few cities had enough hospital space to quarantine patients in the event of a large-scale outbreak of an infectious disease like SARS. I'm curious if you share those beliefs; and, if so, what recommendations would you make to rectify the situation. Ms. Selecky. The answer is, yes; and the recommendation is continued and increased support to State and local public health is absolutely needed from Congress. This is not about a part of the body disease. It's not about a singular kind of action. It's about the investment in the public health system. Our laboratories need to have up-to-date information but up-to- date equipment. Technology changes quickly. What used to take days to grow a culture on now can have rapid testing within hours. We've got to have those kinds of investments. The bioterrorism preparedness money helped us make a major shift, but there needs to be continuation on that and particularly our work with our facilities. You know, our hospitals in this country have come down to a much smaller operating margin. There isn't much room available for the emergency kind of planning that goes on. Again, Congress has done some investments. We in public health at the State and local level are working very closely, for example, in Washington State, with our 91 hospitals to work at the community level to deal with surge capacity. You don't make beds overnight, but you can work on plans how to deal with people if you have a major event. Mr. Bell. Dr. Foldy. Dr. Foldy. I would concur. I would also add that issues like isolation are particularly thorny for local government. I believe that Wisconsin is typical of many States where the responsibility for bearing the cost of isolation lay in the local jurisdiction, which means that a single case of tuberculosis can wipe out the budget of a small health department overnight. It seems somewhat ridiculous. Those kinds of costs need to be socialized in some manner over a larger territory than the small local jurisdiction. Mr. Bell. Thank you, Mr. Chairman. Mr. Shays. I thank the gentleman. Dr. Hall, when I look at that map at the back, it has surveillance of human influenza. And I look at India and it has one--I guess just greater than one laboratory. But how many? Not many? It's not a network. Is that your point? Dr. Hall. Yes. I mean, what's missing there is, yes, a national network so that all areas within that country can be detected, that some polls can be taken from patients and that they can be assessed and evaluated properly. Mr. Shays. I look at the two largest in terms of population, China and India, and that they don't have a network system yet. Walk me through really--I'm not looking in great detail, but I will tell you I am somewhat haunted by--maybe others as well, but this was one story, the story of the mom leaving Hong Kong, going to Toronto. She's infected. She dies. Her son dies. I mean, what a horrible--not only do you lose your life, but someone who you brought into life loses their life. And that could have been prevented--correct--had we known sooner in China, had China participated sooner and acknowledged the problem, correct? Dr. Hall. Well, certainly what we have seen is that within 24 hours of that occurring, of the cases landing in Toronto, WHO put out a global alert. And since the global alert, because of the heightened vigilance all around the world, with the exception of Taiwan we haven't seen that rapid transmission of disease anywhere else. So, yes, the early detection and the early release of information and the heightened vigilance that has occurred has meant that, while cases have occurred, say, in the United States, they are isolated cases, and we haven't seen that level of transfer. So that the real lesson of SARS is that the more transparent countries are, the quicker they report the cases, the quicker the international assistance can get there to look and help with the diagnosis if that's necessary, then the greater the window of opportunity for the rest of the world to be able to protect themselves against these diseases that can in a matter of hours fly around the world. Mr. Shays. Right. What I'm trying to sort out, though, is we up on the panel are thinking we could do so much better. But you say we have a network; and we are looking at this network and saying, it could be so much better. Correct? Dr. Hall. Um-hmm. Mr. Shays. So even when I look at the dark-colored parts and all of Russia and the Scandinavian countries and most of Europe, I'm looking at some of the European nations I guess not--I am--you do agree that, when you look at this network, this network could be so much better. Correct? Dr. Hall. Absolutely. Yes. I mean, it's just an example of just the FluNet, but it's pretty reflective of surveillance on the global level for virtually any disease. Mr. Shays. When you talked about early detection and early intervention. And I think that's kind of where my colleague Mr. Janklow and I are wrestling, as well as Mr. Bell. The question is, we have a system now that may not provide for early intervention. When you look at those countries that have a network, what don't they have? In other words, you could compare to the network ones and say, compared to China and India, you know, they are way ahead. But what don't we have in the United States, as far as you can tell? Dr. Hall. I mean, I think the rest of the panel have been explaining exactly where the problems are. Mr. Shays. But I'm using your--I'm taking advantage of your global view to say how much better it could be. Dr. Hall. Right. I mean, I think the key issues are about the timeliness of reporting and standardizing reporting as well, so that you get a similar report from all around the world. And that I'm sure will probably apply to the States within the United States. So that you can actually compare and you can compile that information to get a much better picture. Quite often, in the emergence of a disease--and this would be the same, the bioterrorist threats--it's unknown, it's different, it follows a pattern you have not seen before. So what is key is to be able to rapidly piece little pieces of the jigsaw puzzle together? And I would imagine that in the United States, as most countries around the world, suffering the problems of reporting in a standardized manner so it can be compared from different bits of the States and reporting in a timely manner so that those pieces can be very rapidly put together in a better picture. Mr. Shays. Now, you talk about a learning curve, but I'm struck by the fact that--I've been chairman now for 9 years of either--the first 4 years was overseeing CDC and FDA and HHS, among other departments and agencies; and now I'm involved with my colleagues on the national security side. But there is some real compatibility. I mean, thank goodness I had that knowledge to bring in here. One of the things I wrote down is, you can't push science. You know, when we were looking at Gulf War illnesses, they said, you know, it make take 10, 15 years for us to understand why people are sick. And I'm thinking up here, well, they are dying and they are sick and so on, and it's going to take 15 years. And it's like, we can't push science. But I wonder, this isn't pushing science. This is different than pushing science. This is saying we have information. We need to find a way to identify it sooner. We need to find a way to identify the illnesses sooner, have a standard. This to me isn't science. This is like logic. And yet I think I'm hearing scientists saying, thinking like that this is going to be a long process. Ms. Ignagni, how are you reacting to what I'm saying? Ms. Ignagni. I think it is like putting down pylons. If you think about creating the architecture, doing something here that collects the system of systems, you really just--in constructing a building, you construct buildings the same way all around the world and all around our country. And so, just to be very simple about it, I think you are on the right track. I think that what we've learned is there's a real value in consistency. I think Dr. Hall is making a very compelling point here. I think what--our colleagues from the States and the local area are sending messages, let's figure out a way to have the consistency of drawing the data but at the same time not quash their ability to be nimble in reacting to that. And I think that--so the question is, where do you put the fulcrum on those two--on the continuum? And I think you are on the right track. Mr. Shays. I also am thinking that--and this is a slight exaggeration. But health departments have been so beaten down in terms of the contest with other departments in the cities and in the States that they have low expectations, and they have learned to be very patient people. Maybe the science tells you to be patient, but it strikes me that the expectation should be a lot higher; and I didn't really come to that conclusion until really wrestling with the first panel now and the second. There is really no reason why--I mean, some of this, as I am struck thinking about it, is some of this is just common sense stuff. And Ms. Selecky, do you want to just comment? Ms. Selecky. We in public health have to be ready to move on a moment's notice, because communicable disease does not work. We can't---- Mr. Shays. Does not what? Ms. Selecky. Does not wait. Excuse me. We can't wait for someone to say, here is the perfect system that is going to be used nationally. So that's why I think you have things that grow up like the one that's in southwest Pennsylvania, as was described earlier, or other places, in the local community to say how do we get our arms around Milwaukee, Seattle, eastern Washington, whatever it is. How do we get ourselves to talk to one another in real-time to work on instant reporting of something that is a terrorist event? It's an unusual disease that's showing up. We are all starting to see it, and we need to move on it. I guess I'm struggling with how to answer your questions about should we nationalize and have a common data reporting system. How do you then get everybody using the same software in the local doctor's office that's part of a health plan who also have four or five other health plans there because they have requirements, the local health department, who is part of the city infrastructure, or the county infrastructure? And we can't wait for that, because communicable disease does not wait. Whether it is electronically, whether it is by the telephone, whether it is by paper, public health is impatient to get the information. The sense of urgency is that our science is based on early detection, quick action and prevention. Otherwise, we wouldn't have some of the good health that we do experience in this country or the ability to begin to look at the work that the World Health Organization, all of a sudden connected to me in my job in Washington State and in my community. So if we haven't talked about urgency, it's about--it's not about the sense of urgency of participating in a good, thoughtful discussion about what's the best system. The urgency exists by virtue of a public health or an organism problem that we have to act on, regardless of what system exists. Mr. Shays. Go ahead. Dr. Foldy. Well, just since--over the last several years, we have done everything possible we can do without spending a lot of money; and that included getting 15 local health jurisdictions to all report to a one-stop location and which can rapidly take in the report, determine that something is going on. Our first--you know, E-coli operated--the first five cases came from five suburbs. Fortunately, they all report to one location. We could put it together and act immediately. Our use of this regional emergency medical Internet, it simply fell into our hands. With more resources, we can do great things. However, my local tax base, as the support for my department has gone from 45 percent down to--it's starting to approach--I'm sorry--55 percent, starting to approach 40. The State is cutting back. We are really looking at hard times and sustaining these systems can't go on indefinitely. Mr. Shays. My time has run out. But, Dr. Hall, what would you like to say? Dr. Hall. Just to say that certainly, from our point of view at Global Alert and Response, we spend far too much time being reactive and not enough time being proactive; and that is simply because of a lack of investment in the system. It means we have enough money to buy the brakes, but we haven't got enough money or time to get the motor to stick it all together. And what you see--that systems I'm sure all around the world building up, building on experience like we have built on the experience of ebola and meningitis outbreaks and other things but never quite enough time to glue that together so that you actually have a system that is stream--that means that information can flow very quickly and very rapidly. Ms. Ignagni. Mr. Chairman, can I make a quick comment? One of the things that I think has probably been implicit in the discussion, particularly from the previous panel, but wasn't said very specifically is that in the last couple of years there has been a dramatic progress in the ability to unite the systems and create a system of systems. What now we have the capacity to do, like we do in defense where we have command centers tracking what's going on around the country, the Secretary has created a command center in terms of getting the information in, looking and arraying the information. If you go into that command center, what you see are different geographic locations and the ability just to put up on the wall where blips are coming up. And I think perhaps what you have been hearing this afternoon is a reflection on how far that has gone and come from where we were. But I think, just as we have learned in this country that we need to take a new approach to thinking about defense as well, I think that the consensus in the public health community is that we need to think more like that in public health. So I think that there has been a dramatic progress over the last couple of years and now it's the question of how we get to where you are suggesting we need to go, and I believe that there is tremendous consensus about that objective, and I think we can do it. There is probably more interest in achieving that now post SARS and some other experiences than there was a year or so ago throughout the country. Mr. Shays. Thank you very much. I appreciate the patience of my colleagues. I don't always do this, but Dr. Kelley, Colonel Kelley, do you have any observation you would want to put on the record? I would have to swear you in, but if you would like to, I would be happy to have you come up. So the answer first has to be yes or no. Colonel Kelley. Yes. Mr. Shays. OK. And with the indulgence of the committee, I would just swear you in. If you would raise your right hand, please. [Witness sworn.] Mr. Shays. I appreciate you, Dr. Kelley, staying for this hearing. I know your superior was here. I mean--but what observation would you like to make? STATEMENT OF PATRICK W. KELLEY, M.D., DR PH, COLONEL, MEDICAL CORPS, DIRECTOR, DEPARTMENT OF DEFENSE, GLOBAL EMERGING INFECTIONS SURVEILLANCE AND RESPONSE SYSTEM Colonel Kelley. I think I would like to make several observations. You know, money can go only so far. But what we really need is leadership to make it clear that these are our priorities that need to be followed. In our various organizations, civilian and military, there are many, many issues that we are trying to balance back and forth and prioritize. We have to prioritize not only budgets but time, and it's very critical I think that our leaders understand that this needs to be a priority. I think one thing we have to realize, too, is that surveillance implies a response. I can't put a precise figure on this, but I would guess for every dollar you spend on surveillance you need several available to fund the response that is implied by the generation of this new information, and I know various health departments outside the military that find that a particular challenge. Now that their surveillance systems are getting better, they have to--they find themselves constrained in reacting to the wonderful data that they are generating. Mr. Shays. We will note for the record that Ms. Selecky and Dr. Foldy were nodding their heads continuously as you were talking about that. OK, anything else? Colonel Kelley. No, sir. Thank you for the opportunity. Mr. Shays. Well, you are welcome. But thank you for staying, and thank you for your good work as well. Is there anything? Mr. Janklow, any other comments you want to make again? Mr. Janklow. Could I ask a couple quick questions, Mr. Chairman? Mr. Shays. You sure can. Mr. Janklow. With respect to the--Dr. Foldy, if I could ask you--and let me ask you, Ms. Selecky, first. In the State of Washington, are you satisfied that you are where you want to be in the State with respect to the reporting system for State purposes? Ms. Selecky. No, and the reason I say no is because we all can do better; and I think that last comment is part of that. You not only need the way you do the reporting, you need to have the foot soldiers to do the work at both the State and local level. The communications system's in place to work to make sure that the public and private people across the State are getting the information to take the action. Can we do it better? Absolutely. We need to upgrade electronic capability across the State. We have already reviewed our reportable diseases in Washington State. We updated them just 2 years ago. We updated our quarantine and isolation rules just in December. We have those kinds of tools. But we have to continue to work on the common data, elements that all of us will agree on come together in Washington State. We are doing better than we were. Mr. Janklow. Are there a set--do you have common data elements in place? Ms. Selecky. We have common reporting from all our private providers as well as public providers in and around the list of communicable diseases that includes emerging diseases like SARS, and in real-time in Washington State we have those kinds of reports to know what we have going on with that. Whether it's E-coli from spouts--we have that from this summer--E-coli from lettuce--it was multi-state. We had it this summer. It's about getting that information to move into action. When I hear you all talk about and when we talk about a common system, I get concerned that we are waiting for the perfect system when what we really need to have are the foundations to be able to use whatever system exists. Mr. Janklow. When I talk about electronics, ma'am--I understand an earthquake can be disruptive. But I don't see a national earthquake coming. I mean, if anything, it would be very regional in terms of its scope; and so I don't know of another effective means other than electronics in war. If we have to go to paper, we can. But to the extent we go to paper, we've lost. Once we have to take the war dealing with someone deliberately injuring our people with bacteria or a toxin or a virus, at that point we have lost. So what I'm wondering is, putting a system in place, what does it take to do it? Because electronically the world is there. It's there. The kids know it. Napster knows it. The only people that don't know it most of the time are the governments and the adults, but the kids have figured it out, whether it's with their chatrooms or whatever. Second of all, I don't think it's that difficult. I realize there could be arguments, but I don't think it's that difficult to come up with a list of sicknesses, diseases, symptoms, differential diagnosis, whatever you want to call it, that are reportable events. The third thing is, there has been a huge amount of Federal money, of national money, our money, that has gone in in the previous couple of years. All the States received very sizable grants, one for their laboratories and two for their planning for this type of thing. And so I understand it's not enough, but it's a huge amount of money if it was somehow coordinated better than we all coordinate it. So I realize our time is up on this stuff, but I just--the point that I'm trying to raise is, is there--and I realize we need more trained people and we need more money. But, absent those things, is it OK the way the States and local governments are doing it? Or is there something that all of us can do in a national wartime scope that would make this more effective and more efficient in terms of the wartime side of this issue? Ms. Selecky. One of the things we clearly do have to work on, and are working on, are secure ways of getting this information sent between State and local; and that is using the common standards you heard Dr. Fleming talk about. So we are working on that. You are saying, speed it up. You are saying, get it done because we are in a wartime kind of thing. It's not about laissez-faire. And I would absolutely agree with you, your point about it makes sense to come up with a common list of diseases. States have those. States work with State and local. We are based on that. So that one you rest assured on. Your point about the earthquake is well made. What we have to do is not falsely rely on it as the exclusive way of doing things. The investments made by Congress over 2 years have moved us along, but I want to have a digital signature in every clinician's office at some point, that clinician can have someone enter the data from their office, from their outlying remote clinic or from their ER room so that the local health department and the State health department have access to that immediately and we transmit it to the Feds. Mr. Shays. We can keep going on and on and on, but I think this is probably a good time to stop. You have been a wonderful panel. You have helped put the whole thing together for us, and we appreciate your participation. Thank you very much. With that, we will adjourn the hearing. Thank you. 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