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PUBLIC HEALTH SYSTEMS AND MERGING INFECTIONS Assessing the Capabilities of the Public and Private Sectors Workshop Summary Jonathan R. Davis and Joshua Lederberg, Editors Based on a Workshop of the Forum on Emerging Infections Division of Health Sciences Policy INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this workshop summary was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. Support for this project was provided by the U.S. Department of Health and Human Services' National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration; U.S. Department of State, Bureau of Oceans and Interna- tional Environmental and Scientific Affairs; U.S. Department of Veterans Affairs; Abbott Laboratories; American Society for Microbiology; Applied Microbiology, Inc.; Bristol- Myers Squibb Company; Burroughs Wellcome Fund; Eli Lilly & Company; Glaxo Well- come; F. Hoffmann-La Roche, AG; Merck; Pfizer, Inc.; SmithKline Beecham Corpora- tion; and Wyeth-Ayerst Laboratories. The views presented are those of the editors and workshop participants, and are not necessarily those of the funding organizations. This report is based on the proceedings of a workshop that was sponsored by the Fo- rum on Emerging Infections. It is prepared in the form of a workshop summary by and in the name of the editors with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editors and not those of the Forum on Emerging Infec- tions. The content of those sections is based on the presentations and the discussions that took place during the workshop. International Standard Book No. 0-309-06829-0 Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP's on-line bookstore at www.nap.edu. The full text is available on line at www.nap.edu. For information about the Institute of Medicine, visit the IOM home page at www. iom.edu. Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. COVER: The background for the cover of this workshop summary is a photograph of a batik designed and printed specifically for the Malaysian Society of Parasitology and Tropical Medicine. The print contains drawings of various parasites and insects; it is used with the kind permission of the Society.

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#~- ~ Off ~~i ~~ Oaf - Off ~~{ ~~ Oaf go. Coetbe INSTITUTE OF MEDICINE Shoplng the Future for Health

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National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council .. -: ~ ... `~ .~ I. . The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of . . Engmeer~ng. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the re- sponsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the Na- tional Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council

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FORUM ON EMERGING INFECTIONS JOSHUA LEDERBERG (Chair), Sackler Foundation Scholar, The Rockefel- ler University VINCENT I. AHONKHAI, Vice President and Director, Anti-Infectives and Biologicals, SmithKline Beecham Corporation, Collegeville, Pennsylvania STEVEN J. BRICKNER, Manager of Medicinal Chemistry, Central Research Division, Pfizer, Inc., Groton, Connecticut GAIL H. CASSELL, Vice President for Infectious Diseases Research, Drag Discovery Research, and Clinical Investigation, Eli Lilly & Company, Indi- anapolis, Indiana GARY CHRISTOPHERSON, Principal Deputy Assistant Secretary for Health Affairs and Senior Advisor for Force Health Protection, U.S. Department of Defense Reserve Affairs, Washington, D.C. GORDON H. DeFRIESE, Director and Professor of Social Medicine, Epide- miology, Health Policy, and Administration, Sheps Center for Health Serv- ices Research, University of North Carolina, Chapel Hill CEDRIC E. DUMONT, Medical Director, Office of Medical Services, U.S. Department of State, Washington, D.C.~ NANCY CARTER-FOSTER, Director, Program for Emerging Infections and HIVlAIDS, U.S. Department of State, Washington, D.C.2 JESSE GOODMAN, Acting Deputy Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Washington, D.C.i RENU GUPTA, Vice President, Medical Safety and Therapeutics, Covance, Inc., Princeton, New Jersey MARGARET A. HAMBURG, Assistant Secretary for Planning and Evalua- tion, U.S. Department of Health and Human Services, Washington, D.C. CAROLE A. HEILMAN, Director, Division of Microbiology and Infectious Disease, National Institutes of Allergy and Infectious Diseases, National In- stitutes of Health, Bethesda, Maryland DIETER HINZEN, Professor and Head of Preclinical Research, F. Hoffmann- La Roche, AG, Basel, Switzerland2 JAMES M. HUGHES, Assistant Surgeon General, and Director, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia J. STANLEY HULL, Vice President, Global Commercial Development, Glaxo Wellcome, Research Triangle Park, North Carolina ~Forum member as of October 1999. 2Forum member at time of workshop.

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SAMUEL L. KATZ, Chairman of the Board, Burroughs Wellcome Fund, and Wilburt C. Davison Professor, Department of Pediatrics, Duke University Medical Center KENNETH W. KIZER, Undersecretary for Health, Veterans Health Admini- stration, U.S. Department of Veterans Affairs, Washington, D.C.2 3 WILLIAM KOHLBRENNER, Director, Antiviral Research, Abbott Laborato- ries, Abbott Park, Illinois2 JOHN R. LaMONTAGNE, Deputy Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland2 MARCELLE LAYTON, Bureau of Communicable Diseases, New York City Department of Health CARLOS LOPEZ, Executive Director, Infectious Disease Research, Eli Lilly Research Laboratories, Indianapolis, Indiana STEPHEN S. MORSE, Assistant Professor of Epidemiology, Columbia Uni- versity School of Public Health, and Defense Advanced Research Projects Agency/Defense Sciences Office, Washington, D.C. SOLOMON MOWSHOWITZ, Vice President, Research and Development, Applied Microbiology, Inc., Tarrytown, New York2 4 STUART L. NIGHTINGALE, Associate Commissioner for Health Affairs, U.S. Food and Drug Administration, U.S. Department of Health and Human Services, Rockville, Maryland2 MICHAEL T. OSTERHOLM, State Epidemiologist and Chief, Acute Disease Epidemiology Section, Minnesota Department of Health, Minneapolis5 MARC RUBIN, Vice President of Infectious Diseases Therapeutic Develop- ment Group, Glaxo Wellcome, Research Triangle Park, North Carolinas DAVID M. SHLAES, Vice President, Infectious Disease Research, Wyeth- Ayerst Research, Pearl River, New York City JANET SHOEMAKER, Director, Public Affairs, The American Society for Microbiology, Washington, D.C.~ JOHN D. SIEGFRIED, Deputy Vice-President, Science and Regulatory Affairs, Pharmaceutical Research and Manufacturers of America, Washington, D.C. P. FREDERICK SPARLING, Chair of Medicine, University of North Caro- lina at Chapel Hill, and President, Infectious Diseases Society of America, Washington, D.C. C. DOUGLAS WEBB JR., Senior Medical Director, Infectious Diseases Global Marketing, Bristol-Myers Squibb, Princeton, New Jersey CATHERINE E. WOTEKI, Undersecretary for Food and Safety, U.S. De- partment of Agriculture, Washington, D.C.~ 3At time of printing, President and Chief Executive Officer, National Quality Fo- rum, Washington, D.C. 4At time of printing, President, Diligen, New York City. sAt time of printing, Chairman and Chief Executive Officer, Infectious Control Ad- visory Network, Eden Prairie Minnesota. V1

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Liaisons to the Forum BARRY R. BLOOM, Investigator, Howard Hughes Medical Institute, and A1- bert Einstein College of Medicine, Yeshiva University ENRIQUETA C. BOND, President, Burroughs Wellcome Fund, Morrisville, North Carolina MICHAEL HUGHES, Office of the Undersecretary, Veterans Health Adrnini- stration, U.S. Department of Veterans Affairs, Washington, D.C. STEPHANIE JAMES, Parasitology and International Programs Branch, Divi- sion of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland PATRICK W. KELLEY, Colonel, U.S. Army, and Director, Division of Preven- tive Medicine, Walter Reed Army Institute of Research, Washington, D.C.6 STEPHEN M. OSTROFF, Acting Deputy Director, and Associate Director for Epidemiologic Science, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia GARY ROSELLE, Program Director for Infectious Disease, Veterans Health Administration, U.S. Department of Veterans Affairs, Cincinnati, Ohio JAMES M. SIGG, Contract Liaison Officer, Office of Management and Con- tract, Centers for Biologics Evaluation and Research, U.S. Food and Drug Administration, Washington, D.C.6 FRED TENOVER, Chief, Nosocomial Pathogens Laboratory Branch, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia KAYE WACHSMUTH, Deputy Administrator, Office of Public Health and Science, Food Safety Insection Service, U.S. Department of Agricultures Study Staff JONATHAN R. DAVIS, Senior Program Officer VIVIAN P. NOLAN, Research Associate NICOLE AMADO, Project Assistant KATHI MANNA, Consultant MICHAEL HAYES, Copy Editor Division Staff ANDREW M. POPE, Division Director SARAH PITLUCK, Research Assistant ALDEN CHANG, Project Assistant THELMA COX, Project Assistant CARLOS GABRIEL, Financial Associate 6Liaison to the Forum as of October 1999 . . V11

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REVIEWERS All presenters at the workshop have reviewed and approved their respective sections of this report for accuracy. In addition, this workshop summary has been reviewed in draft form by independent reviewers chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine (IOM) in making the published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The Forum and IOM thank the following individuals for their participation in the review process: Kenneth Bart, San Diego State University Graduate School of Public Health Donna Crane, American Public Health Association Walter R. Dowdle, Emory University School of Public Health Task Force for Child Survival and Development Laura Efros, White House Office of Science and Technology Policy Adel Mahmoud, Merck Vaccines, Inc. David Smith, Texas Tech University Health Sciences Center Although the independent reviewers have provided many constructive comments and suggestions, responsibility for the final content of this workshop summary rests solely with the editors. . . . vail

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Preface The Forum on Emerging Infections was created in 1996 in response to a re- quest from the Centers for Disease Control and Prevention and the National In- stitutes of Health. The goal of the Forum is to provide structured opportunities for representatives from academia, industry, professional and interest groups, and government* to examine and discuss scientific and policy issues that are of shared interest and that are specifically related to research and prevention, de- tection, and management of emerging infectious diseases. In accomplishing this task, the Forum provides the opportunity to foster the exchange of information and ideas, identify areas in need of greater attention, clarify policy issues by enhancing knowledge and identifying points of agreement, and inform decision makers about science and policy issues. The Forum seeks to illuminate issues rather than resolve them directly, hence it does not provide advice or recom- mendations on any specific policy initiative pending before any agency or or- ganization. Its strengths are the diversity of its membership and the commitment of individual members expressed throughout the activities of the Forum. A critical part of the work of the Forum is a series of workshops. The first of these, held in February 1997, addressed the theme of public- and private- sector collaboration (IOM, 1997b). The second workshop took place in July 1997 and explored aspects of antimicrobial resistance (IOM, 1998~. The third workshop (IOM, 2000), examined the implications of managed care systems and Representatives of federal agencies serve in an ex officio capacity. An ex officio member of a group is one who is a member automatically by virtue of holding a particu- lar office or membership in another body. 1X

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x PREFACE the ability to address emerging infectious diseases in the age of managed care. The fourth workshop, which this document summarizes, examined the core ca- pacities of the public and private health sectors in emerging infectious disease surveillance and response. The fifth workshop, October 1999, examined the in- ternational aspects of emerging infections. The summary of that workshop is in production. The topic of zoonotic diseases will be the focus for the Forum's sixth workshop, to be held in June 2000. ABOUT THE WORKSHOP The changing face of health care poses new challenges for the detection, treatment, and prevention of infectious diseases. Historically, local public health departments, hospitals, and clinics have been at the forefront of infectious dis- ease outbreak detection and treatment. However, the health care system has changed, and managed care organizations and privatized public health laborato- ries (often privatized for political reasons) continue to grow in response to the needs of the communities they serve. Yet, simultaneously, many of the system's abilities to perform its functions of public health laboratories and epidemiologi- cal services may be eroding. Along with that erosion, local public health systems may have a diminished capacity to detect and respond to an emerging infectious disease. In an effort to increase our knowledge and understanding of the role of the private and public health sectors in emerging infectious disease surveillance and response, this workshop, entitled Public Health Systems: Assessing Capacities to Respond to Emerging Infections, explored how the privatization of public health laboratories and the modernization of public health care may effect infectious disease surveillance and outbreak detection. A central theme running throughout the workshop was the problematical capacity of public health systems at the state and local levels to detect and respond to an infectious disease outbreak. The workshop served to open a dialogue on public health systems to identify and dis- cuss issues of mutual concern among representatives from the affected parties and groups. These issues were broken down into the following four thematic ar- eas, which addressed various components of the public health system: 1. epidemiological investigation; 2. surveillance; 3. communication, coordination, and education and outreach; and 4. strategic planning, resource allocation, and economic support. Representatives from the public health community, hospitals, government agencies, pharmaceutical companies, and academia were invited to give panel presentations moderated by Forum members. Each panelist was asked to high- light important issues, suggest possible practical solutions, and indicate impedi-

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PREFACE X1 meets that must be overcome to improve infectious disease surveillance and response, communication and coordination, and education and outreach. ORGANIZATION OF THE WORKSHOP SUMMARY This report of the Forum-sponsored workshop is prepared in the form of a workshop summary by and in the name of the editors with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the edi- tors and not those of the Forum on Emerging Infections, nor its sponsors. The content of those sections is based on the presentations that took place during the workshop. The workshop summary is organized as a topic-by-topic description of the presentations and discussions that occurred during the workshop. Its purpose is to present lessons from relevant experience, delineate a range of pivotal issues and their respective problems, and put forth some potential responses as de- scribed by the workshop participants. The Summary and Assessement chapter discusses the core messages that emerged from the speaker presentations and ensuing discussions. Chapter 1 is an introduction to the topic and overview of the main issues confronting public health systems. Chapters 2 to 5 begin with opening statements that provide context and background information by the editors, followed by descriptions of the presentations that were made by the in- vited participants. Appendix A is a glossary and list of acronyms useful for the topics. Appendix B presents the workshop agenda. A summary of the GAO re- port on Emerging Infectious Diseases is found in Appendix C. Forum members and staff biographies are presented in Appendix D. Although this workshop summary provides an account of the individual presentations, it also reflects a very important aspect of the Forum philosophy. The workshop functions as a dialogue among representatives from different sectors and presents their beliefs on which areas may merit further attention. However, the reader should be aware that the material presented here expresses the views and opinions of those participating in the workshop and not the delib- erations of a formally constituted Institute of Medicine study committee. These proceedings summarize only what participants stated in the workshop and are not intended to be an exhaustive exploration of the subject matter.

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X11 PREFACE ACKNOWLEDGMENTS The Forum and the Institute of Medicine wish to express their warmest ap- preciation to the individuals and organizations who gave valuable time to pro- vide information and advice to the Forum through participation in the workshop. Each of the following contributed greatly: Scott Becker, Association of Public Health Laboratories (APHL); Cheryl Beversdorf, Association of State and Ter- ritorial Health Officials (ASTHO); Eric Blank, APHL; Judy Buckalew, Office of Senator Lauch Faircloth; Jack Chow, Senate Appropriations Committee, Labor, Health, and Human Services Subcommittee; Donna Crane, American Public Health Association; Ellen Gadbois, Office of Senator Edward Kennedy; Mary Gilchrist, University of Iowa Hygienic Laboratory; JoAnne Glisson, American Clinical Laboratory Association; James Hadler, Connecticut Department of Health; Peggy Hamburg, Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services; Tracey Hooker, National Confer- ence of State Legislators; Eileen Koski, Quest Diagnostics; Marsha Lillie- Blanton, U.S. General Accounting Office; Laurence McCarthy, MRL Pharma- ceuticals, Inc.; Joe McDade, Centers for Disease Control and Prevention; Linda Miller, SmithKline, Beecham; Ellen Morrison, U.S. Food and Drug Administra- tion; Steve Ostroff, National Center for Infectious Diseases (NCID), CDC; Patricia Quinlisk, Iowa Department of Health, Council of State and Territorial Epidemiologists; James Pearson, Division of Consolidated Laboratory Services, Commonwealth of Virginia; Gianfranco Pezzino, Kansas Department of Health and Environment; Robert Pinner, NCID/CDC; William L. Roper, Dean, School of Public Health, University of North Carolina; Robert Rubin, The Lewin Group; Ted Shortliffe, Stanford University; Catherine Slemp, West Virginia Department of Health; Larry Strausbaugh, Portland VA Medical Center; Bala Swaminathan, NCID/CDC; Fred Edgar Thompson, Jr., Mississippi Department of Health, ASTHO; Helene Toiv, GAO; and Kathleen Young, Alliance for the Prudent Use of Antibiotics. The Forum is indebted to the IOM staff who contributed during the course of the workshop and the production of this workshop summary. On behalf of the Forum, I gratefully acknowledge the efforts led by Jonathan Davis, study direc- tor for the Forum and co-editor of this report, who dedicated much effort and time to developing this workshop's agenda and for his thoughtful and insightful approach and skill in translating the workshop proceedings and discussion into this workshop summary. I would also like to thank the following IOM staff for their valuable contributions to this activity: Vivian Nolan assisted with the de- velopment of the workshop agenda, provided detailed support to facilitate the development of the workshop summary, and assisted with editing various sec- tions of the workshop summary in response to the review process; Nicole Amado assisted in developing the Glossary and Acronyms list and provided comprehensive administrative support; and Sarah Pitluck, Alden Chang, Thelma

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PREFACE X111 Cox, and Hattie Wilfert provided expert support at various developmental stages of the workshop summary. Other IOM staff also provided invaluable help: Sue Barron, Clyde Behney, Claudia Carl, Michael Edington, Carlos Gabriel, and Andrew Pope. Consultant and technical writer, Kathi Hanna, contributed signifi- cantly to writing many sections of the workshop summary. The extensive com- mentary and suggestions made by the copy editor, Michael Hayes, are gratefully acknowledged. Finally, the Forum also thanks its sponsors that supported this activity. Fi- nancial support for this project was provided by the U.S. Department of Health and Human Services' National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration; U.S. Department of State, Bureau of Oceans and International Environmental and Scientific Affairs; U.S. Department of Veterans Affairs; Abbott Laboratories; American Society for Microbiology; Applied Microbiology, Inc.; Bristol-Myers Squibb Company; Burroughs Wellcome Fund; Eli Lilly & Company; Glaxo Wellcome; F. Hoff- mann-La Roche; Merck Co., Inc.; Pfizer; SmithKline Beecham; and Wyeth- Ayerst Laboratories. Joshua Lederberg Chair

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Contents SUMMARY AND ASSESSMENT Assessing the Capability, 3 Strengthening the Capability, 11 Concluding Remarks, 22 1 INTRODUCTION 24 Background, 24 Changing Landscape of Public Health, 26 EPIDEMIOLOGICAL INVESTIGATION 29 Overview, 29 National Perspective on Outbreak Investigations, 30 State Perspectives on Outbreak Investigations, 33 County-Level Perspective on Outbreak Investigations, 36 Perspectives of Physicians' Community, 37 Public Health Practice and the Role of Academic Public Health, 39 3 SURVEILLANCE Overview, 42 GAO Report on Public Health Surveillance of Emerging Infectious Diseases, 43 Emerging Infections Program Cooperative Agreement, 44 Large National Commercial Laboratories, 50 xv 42

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XVI CONTENTS Role of the Public-Sector Laboratory at the National Level, 52 Role of the Public-Sector Laboratory at the State Level, 54 4 COMMUNICATION, COORDINATION, AND EDUCATION AND OUTREACH 57 Overview, 57 Communication and Coordination at the National Level: The Pulsenet Model, 57 Communication and Coordination at the State Level, 60 Nongovernmental Organizations and State Partnerships, 62 Continuing Education: The Role of Professional Organizations, 64 Role of Medical Information in Detection and Management of Emerging Infections, 65 STRATEGIC PLANNING, RESOURCE ALLOCATION, AND ECONOMIC SUPPORT Overview, 68 Legislation and Mandates at the Federal Level, 68 Congressional Response to the Threat of Infectious Diseases, 70 State Health Official Perspective, 71 Laboratory-Based Reporting Issues, 72 REFERENCES APPENDIXES A Glossary and Acronyms, 77 B Workshop Agenda, 84 C Emerging Infectious Diseases: Consensus on Needed Laboratory Capacity Could Strengthen Surveillance, 90 D Forum Member and Staff Biographies, 97 68 75

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PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS

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