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APPENDIX C Emerging infectious Diseases . O O Consensus on Needed Laboratory Capacity Could Strengthen Surveillance SUMMARY Pursuant to a congressional request, GAO reviewed the nation's infectious diseases surveillance network, focusing on the: (1) extent to which states con- duct public health surveillance and laboratory testing of selected emerging in- fectious diseases; (2) problems state public health officials face in gathering and using laboratory-related data in the surveillance of emerging infectious diseases; and (3) assistance that the Department of Health and Human Services' Centers for Disease Control and Prevention (CDC) provides to states for laboratory- related surveillance and the value of this assistance to state officials. GAO noted that: (1) surveillance and testing for important emerging infec- tious diseases are not comprehensive in all states, leaving gaps in the nation's infectious diseases surveillance network; (2) GAO's survey found that most states conduct surveillance of five of the six emerging infectious diseases GAO asked about, and state public health laboratories conduct tests to support state surveillance of four of the six; (3) over half of the state laboratories do not con- duct tests for surveillance of hepatitis C and penicillin-resistant S. pneumonias; (4) many state epidemiologists believe that their infectious diseases surveillance programs should expand, and they cited a need to gather more information on antibiotic-resistant diseases; (5) just over half of the state public health laborato- This Appendix reprints material extracted from the U.S. General Accounting Office Report, Emerging Infectious Diseases: Consensus on Needed Laboratory Capacity Could Strengthen Surveillance, Report to the Chairman, Subcommittee on Public Health, Com- mittee on Health, Education, Labor, and Pensions, U.S. Senate (February 1999, Rep. No. GAO/HEHS-99-26). 90

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APPENDIX C 91 ries have access to advanced molecular technology, which could be valuable to all states' diseases surveillance efforts; (6) few states require the routine submis- sion of specimens or isolated quantities of a pathogen from patients with certain diseases for testing in state laboratoriesa step CDC has urged them to adopt to improve the quality of surveillance information; (7) many state laboratory di- rectors and epidemiologists reported that inadequate staffing and information- sharing problems hinder their ability to generate and use laboratory data to con- duct infectious diseases surveillance; (8) participants in the surveillance network often lack basic computer hardware or integrated systems to allow them to rap- idly share information; (9) many state officials told GAO that they did not have sufficient staffing and technology resources, and public health officials have not agreed on a consensus definition of the minimum capabilities that state and local health departments need to conduct infectious diseases surveillance; (10) this lack of consensus makes it difficult to assess resource needs; (11) most state laboratory directors and epidemiologists placed high value on CDC's testing and consulting services, training, and grant funding and said these services were critical to their ability to use laboratory data to detect and monitor emerging infections; (12) state officials said CDC needs to better integrate its data systems and help states build systems that link them to local and private surveillance partners; and (13) state officials would like CDC to provide more hands-on . . . training experience. Continued on next page

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92 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS LETTER United States General Accounting Office Health, Education, and Human Services Division Washington, DC 20548 B-280933 February 5, 1999 The Honorable Bill Frist Chairman, Subcommittee on Public Health Committee on Health, Education, Labor, and Pensions United States Senate Dear Mr. Chairman: The spread of infectious diseases is a public health problem once thought to be largely under control. However, outbreaks over the last decade illustrate that infectious diseases remain a serious public health threat. For example, in 1993, more than 400,000 people became ill from a city's drinking water contaminated with Cryptosporidium parvam a common parasite resistant to chlorination and other water treatment measures. Over 4,000 people were hospitalized, and 55 died. In 1996, drinking apple juice contaminated with a virulent strain of E. cold bacteria made more than 60 people seriously ill and caused the death of one per- son. And in 1998, 26 children became ill from playing in a swimming pool con- taminated by a virulent strain of E. coli. Four of the children developed a serious complication that affects the blood and kidneys. The resurgence of some infectious diseases is particularly alarming because previously effective forms of control are breaking down. For example, some pathogens (disease-causing organisms) have become resistant to antibiotics used to bring them under control or have developed strains that no longer respond to the antibiotics. Monitoring infectious diseases identifying diseases and their sources is critical for determining control and prevention efforts. Public health officials refer to this activity as surveillance the ongoing collection, analysis, and inter- pretation of disease-related data to plan, implement, and evaluate public health actions. Many public health experts have raised concerns about the adequacy of the nation's infectious diseases surveillance network, especially for those dis- eases considered to be emerging that is, ones more prevalent now than 20 years ago or ones that show signs of becoming more prevalent in the near future. In light of these concerns, you asked us to examine the nation's surveillance network and to focus on the contribution of laboratories, since new technology

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APPENDIX C 93 gives them an increasingly important role in identifying pathogens and the sources of outbreaks. Specifically, you asked us to (1) determine the extent to which states conduct public health surveillance and laboratory testing of selected emerging infectious diseases, (2) identify the problems state public health offi- cials face in gathering and using laboratory-related data in the surveillance of emerging infectious diseases, and (3) describe the assistance that the Department of Health and Human Services' (HHS) Centers for Disease Control and Preven- tion (CDC) provides to states for laboratory-related surveillance and the value of this assistance to state officials. To provide information on the contribution of laboratories to the surveil- lance network, we surveyed the directors of all state public health laboratories and infectious diseases epidemiology programs that report disease-related in- formation directly to CDC, including officials in all 50 states, 5 territories, the District of Columbia, and New York City.2 We also conducted case studies in Kentucky, New York, and Oregon; spoke with additional state and local public health officials around the country; and interviewed CDC officials. We focused our work on six specific emerging infectious diseases or pathogens: tuberculo- sis, Shiga-like toxin-producing E. cold (including E. cold 0157:H7~3 pertussis, Cryptosporidium parvum, hepatitis C virus, and penicillin-resistant Streptococ- cus pneumonias. Our methodology is described in more detail in appendix I, the results from our surveys are in appendixes II and III, and details on the six dis- eases are in appendix IV. Our work was conducted from December 1997 through December 1998 in accordance with generally accepted government auditing standards. Results in Brief Surveillance and testing for important emerging infectious diseases are not comprehensive in all states, leaving gaps in the nation's infectious diseases sur- veillance network. Our survey found that most states conduct surveillance of five of the six emerging infectious diseases we asked about, and state public health laboratories conduct tests to support state surveillance of four of the six. However, over half of the state laboratories do not conduct tests for surveillance of hepatitis C and penicillin-resistant S. pneumo7~iae. Many state epidemiolo- gists believe that their infectious diseases surveillance programs should expand, and they frequently cited a need to gather more information on antibiotic- resistant diseases. Just over half of the state public health laboratories have ac- ~Epidemiology is the study of the distribution and causes of disease or injury in a population. 2Throughout this report, we refer to this group collectively as "states." 3Shiga-like toxin-producing E. cold belong to a group of virulent E. cold that can produce severe intestinal bleeding. Throughout this report, we will refer to the group by the name of its most well-known member, E. cold 0157:H7.

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94 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS cess to advanced molecular technology, which many experts believe could be valuable to all states' diseases surveillance efforts. Furthermore, few states re- quire the routine submission of specimens or isolated quantities of a pathogen from patients with certain diseases for testing in state laboratories a step CDC has urged them to adopt to improve the quality of surveillance information. Many state laboratory directors and epidemiologists reported that inade- quate staffing and information-sharing problems hinder their ability to generate and use laboratory data to conduct infectious diseases surveillance. For example, they believe that the number of laboratory staff to perform tests and the number of epidemiology staff who can analyze data and translate surveillance informa- tion into disease prevention and control activities are insufficient. They also cited a need for training to ensure that their staffs have the skills to take advan- tage of technological advances in laboratory methods, information-sharing sys- tems, or both. Participants in the surveillance network, particularly at the local level, often lack basic computer hardware or integrated systems to allow them to rapidly share information. State officials also expressed concerns about CDC's many separate data reporting systems, which result in duplication of effort and drain scarce staff resources. Although many state officials told us that they did not have sufficient staffing and technology resources, public health officials have not agreed on a consensus definition of the minimum capabilities that state and local health departments need to conduct infectious diseases surveillance. This lack of consensus makes it difficult to assess resource needs. We are rec- ommending that the Director of CDC lead an effort to help federal, state, and local public health officials create consensus on the core capacities needed at each level of government. CDC provides state and local health departments with a wide range of tech- nical, financial, and staff resources to help maintain or improve their ability to detect and respond to emerging infectious disease threats. Most state laboratory directors and epidemiologists placed high value on CDC's testing and consulting services, training, and grant funding and said these services were critical to their ability to use laboratory data to detect and monitor emerging infections. How- ever, they identified a number of ways in which these services could be im- proved. Specifically, most state officials said CDC needs to better integrate its data systems and help states build systems that link them with local and private surveillance partners. Many state officials would also like CDC to provide more hands-on training experience. State officials also pointed out that obtaining as- sistance with problems that cut across programmatic boundaries could be im- proved if CDC's departments that focus on specific diseases communicated better with one another.

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APPENDIX C 95 Conclusions Public health officials agree that the importance of infectious diseases sur- veillance cannot be overemphasized. The nation's surveillance network is con- sidered the first line of defense in detecting and identifying emerging infectious diseases and providing essential information for developing and assessing pre- vention and control efforts. Laboratories play an increasingly vital role in infec- tious diseases surveillance, as advances in technology continually enhance the specificity of laboratory data and give public health officials new techniques for monitoring emerging infections. Public health officials who spoke with us said that the nation's surveillance system is essentially sound but in need of improvement. They point to outbreaks rapidly identified and contained as visible indications of the system's strength. Our survey results tend to support this view: surveillance of five of the six emerging infectious diseases we asked about is widespread among states, and surveillance of four of the six is supported by testing in state public health labo- ratories. Officials also view CDC's support as essential and are generally very satisfied with both the types and levels of assistance CDC provides. However, our survey also revealed gaps in the infectious diseases surveil- lance network. Just over half of the state public health laboratories have access to molecular technology that many experts believe all states could use, and few states require the routine submission of specimens to their state laboratories for testing a step urged by CDC. In addition, many state epidemiologists believe their surveillance programs do not sufficiently study all infectious diseases they consider important, including antibiotic-resistant conditions and hepatitis C. Both laboratory directors and epidemiologists expressed concerns about the staffing and technology resources they have for surveillance and information sharing. They were particularly frustrated by the lack of integrated information systems within CDC and the lack of integrated systems linking them with other public and private surveillance partners. CDC's continued commitment to inte- grating its own data systems and to helping states and localities build integrated electronic data and communication systems could give state and local public health agencies vital assistance in carrying out their infectious diseases surveil- lance and reporting responsibilities. The lack of a consensus definition of what constitutes an adequate infec- tious diseases surveillance system may contribute to some of the shortcomings in the surveillance network. For example, state public health officials assert that they lack sufficient trained epidemiologic and laboratory staff to adequately study infectious diseases, as well as sufficient resources to take full advantage of advances in laboratory and information-sharing technology. Without agreement on the basic surveillance capabilities state and local health departments should have, however, it is difficult for policymakers to assess the adequacy of existing resources or to identify what new resources are needed to carry out state and

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96 PUBLIC HEALTH SYSTEMS AND EMERGING INFECTIONS local surveillance responsibilities. Moreover, public health officials make deci- sions about how to spend federal dollars to enhance state surveillance activities without such criteria to evaluate where investments are needed most. Recommendation to the Director of CDC To improve the nation's public health surveillance of infectious diseases and help ensure adequate public protection, we recommend that the Director of CDC lead an effort to help federal, state, and local public health officials create consensus on the core capacities needed at each level of government. The con- sensus should address such matters as the number and qualifications of labora- tory and epidemiologic staff, laboratory and information technology, and CDC's support of the nation's infectious diseases surveillance system. Agency Comments CDC officials reviewed a draft of this report. They generally concurred with our findings and recommendation and provided technical or clarifying com- ments, which we incorporated as appropriate. Specifically, CDC agreed that a clearer definition of the needed core epidemiologic and laboratory capacities at the federal, state, and local levels would be useful and that integrated surveil- lance systems are important to comprehensive prevention programs. CDC noted that it is working with other HHS agencies to address these critical areas. We also provided the draft report to APHL and CSTE. APHL officials said the report was comprehensive and articulated the gaps in the current diseases surveillance system well. They also provided technical comments, which we incorporated as appropriate. CSTE officials did not provide comments. As agreed with your office, unless you publicly announce its contents ear- lier, we plan no further distribution of this report until 30 days from the date of this letter. At that time, we will send copies to the Secretary of HHS, the Direc- tor of CDC, the directors of the state epidemiology programs and public health laboratories included in our survey, and other interested parties. We will make copies available to others upon request. If you or your staff have any questions, please contact me or Helene Toiv, Assistant Director, at (202) 512-7119. Other major contributors are included in appendix V. Sincerely yours, Bernice Steinhardt Director Health Services Quality and Public Health Issues