oversight

Emerging Infectious Diseases: Consensus on Needed Laboratory Capacity Could Strengthen Surveillance

Published by the Government Accountability Office on 1999-02-05.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                 United States General Accounting Office

GAO              Report to the Chairman, Subcommittee
                 on Public Health, Committee on Health,
                 Education, Labor, and Pensions, U.S.
                 Senate

February 1999
                 EMERGING INFECTIOUS
                 DISEASES
                 Consensus on Needed
                 Laboratory Capacity
                 Could Strengthen
                 Surveillance




GAO/HEHS-99-26
      United States
GAO   General Accounting Office
      Washington, D.C. 20548

      Health, Education, and
      Human Services Division

      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 parvum—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. coli bacteria made more
      than 60 people seriously ill and caused the death of one person. And in
      1998, 26 children became ill from playing in a swimming pool
      contaminated 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 interpretation 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 diseases 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 gives them an increasingly important role in
      identifying pathogens and the sources of outbreaks. Specifically, you




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                   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 officials 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
                   Prevention (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
                   surveillance network, we surveyed the directors of all state public health
                   laboratories and infectious diseases epidemiology1 programs that report
                   disease-related information 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: tuberculosis, Shiga-like toxin-producing
                   E. coli (including E. coli O157:H7),3 pertussis, Cryptosporidium parvum,
                   hepatitis C virus, and penicillin-resistant Streptococcus pneumoniae. 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 diseases are in
                   appendix IV. Our work was conducted from December 1997 through
                   December 1998 in accordance with generally accepted government
                   auditing standards.


                   Surveillance and testing for important emerging infectious diseases are not
Results in Brief   comprehensive in all states, leaving gaps in the nation’s infectious diseases
                   surveillance 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. pneumoniae. Many state epidemiologists 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

                   1
                    Epidemiology is the study of the distribution and causes of disease or injury in a population.
                   2
                    Throughout this report, we refer to this group collectively as “states.”
                   3
                    Shiga-like toxin-producing E. coli belong to a group of virulent E. coli 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. coli O157:H7.



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half of the state public health laboratories have access to advanced
molecular technology, which many experts believe could be valuable to all
states’ diseases surveillance efforts. Furthermore, few states require 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
inadequate 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 information 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 advantage of technological
advances in laboratory methods, information-sharing systems, 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 recommending 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
technical, 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. However, they identified a number of ways
in which these services could be improved. 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



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             experience. State officials also pointed out that obtaining assistance with
             problems that cut across programmatic boundaries could be improved if
             CDC’s departments that focus on specific diseases communicated better
             with one another.


             Emerging infectious diseases pose a growing health threat to people in this
Background   country and around the world. The causes of this increase are complex
             and often difficult to anticipate. For example, increased development,
             deforestation, and other environmental changes have brought people into
             contact with animals or insects that harbor diseases only rarely
             encountered before. Not all emerging infections are unfamiliar diseases,
             however. Some pathogens have developed resistance to the antibiotics
             that brought them under control just a generation ago. Moreover, the
             threefold increase in international travel during the past 20 years and
             greater importation of fresh foods across national borders allow infectious
             diseases to spread rapidly. As these diseases travel, they interact with
             growing numbers of people who have weakened immunity, such as
             transplant recipients, elderly persons, patients treated with radiation, and
             those infected with HIV/AIDS.

             With the introduction of antibiotics in the 1940s and the development of
             vaccines for diseases like polio, there was widespread optimism that
             infectious diseases could be eliminated completely. As a result, public
             health officials shifted some monitoring efforts to other health problems,
             such as chronic diseases. By 1986, CDC had discontinued surveillance of
             drug-resistance trends in tuberculosis. The resurgence of tuberculosis and
             the appearance of HIV/AIDS thus caught the nation’s public health system off
             guard.

             Today, infectious diseases account for considerable health care costs and
             lost productivity. In the United States, an estimated one-fourth of all
             doctor visits are for infectious diseases. Foodborne illnesses, some of
             which were unrecognized 20 years ago, are estimated to cause up to
             33 million cases and 9,000 deaths annually and to cost as much as
             $22 billion a year. The number of pathogens resistant to one or more
             previously effective antibiotics is increasing rapidly, adding to health care
             costs and threatening to return the nation to the pre-antibiotic era.
             Antibiotic resistance limits effective treatment options, with potentially
             fatal results. Resistant infections that people acquire during
             hospitalizations are estimated to cost as much as $4 billion and cause
             19,000 deaths a year.



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Surveillance Is the Primary       Surveillance is public health officials’ most important tool for detecting
Public Health Tool to             and monitoring both existing and emerging infectious diseases. Without an
Detect and Monitor                adequate surveillance system, local, state, and federal officials cannot
                                  know the true scope of existing health problems and may not recognize
Infections                        new diseases until many people have been affected. They rely on
                                  surveillance data to focus their staff and dollar resources on preventing
                                  and controlling the diseases that most threaten populations within their
                                  jurisdictions. Health officials also use surveillance data to monitor and
                                  evaluate the effectiveness of prevention and control programs.

Passive and Active Surveillance   Because known diseases can become emerging infections by changing in
                                  unanticipated ways, the methods for detecting emerging infections are the
                                  same ones used to monitor infectious diseases generally. These methods
                                  can be characterized as passive or active.

                                  When using passive surveillance methods, public health officials notify
                                  laboratory and hospital staff, physicians, and other relevant sources about
                                  disease data they should report. These sources in turn must take the
                                  initiative to provide data to the health department, where officials analyze
                                  and interpret the information as it comes in.

                                  Under active surveillance, public health officials contact people directly to
                                  gather data. For example, state or local health department staff could call
                                  commercial laboratories each week to ask if any tests conducted for
                                  cryptosporidiosis yielded positive results. Active surveillance produces
                                  more complete information than passive surveillance, but it takes more
                                  time and costs more.

                                  Infectious diseases surveillance in the United States depends largely on
                                  passive methods of collecting disease reports and laboratory test results.
                                  Consequently, the surveillance network relies on the participation of
                                  health care providers, private laboratories, and state and local health
                                  departments across the nation.

Surveillance Depends on           States have principal responsibility for protecting the public’s health and,
Participation by Many             therefore, take the lead role in conducting surveillance. Each state decides
                                  for itself which diseases will be reported to its health department, where
                                  reports should be submitted, and which information it will then pass on to
                                  CDC.


                                  The surveillance process usually begins when a person with a reportable
                                  disease seeks care. To help determine the cause of the patient’s illness, a



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physician may rely on a laboratory test, which could be performed in the
physician’s own office, a hospital, an independent clinical laboratory, or a
public health laboratory. State and local health departments that provide
clinical services also generate laboratory test results for infectious
diseases surveillance.

Local health departments are often the first to receive the reports of
infectious diseases generated by physicians, hospitals, and others. Health
department staff collect these reports, check them for completeness,
contact health care professionals to obtain missing information or clarify
unclear responses, and forward them to state health agencies. Staff
resources devoted to disease reporting vary with the overall size and
mission of the health department. Since nearly half of local health
agencies have jurisdiction over a population of fewer than 25,000, many
cannot support a large, specialized staff to work on disease reporting.

In state health departments, epidemiologists analyze data collected
through the disease reporting network, decide when and how to
supplement passive reporting with active surveillance methods, conduct
outbreak and other disease investigations, and design and evaluate disease
prevention and control efforts. They also transmit state data to CDC,
providing routine reporting on selected diseases. Many state
epidemiologists and laboratory directors provide the medical community
with information obtained through surveillance, such as rates of disease
incidence and prevailing patterns of antimicrobial resistance.

Federal participation in the infectious diseases surveillance network
focuses on CDC activities—particularly those of the National Center for
Infectious Diseases (NCID), which operates CDC’s infectious diseases
laboratories. CDC analyzes the data furnished by states to (1) monitor
national health trends, (2) formulate and implement prevention strategies,
and (3) evaluate state and federal disease prevention efforts. CDC routinely
provides public health officials, medical personnel, and others information
on disease trends and analyses of outbreaks. Through NCID and other
units—such as the National Immunization Program and the National
Center for HIV, Sexually Transmitted Diseases, and Tuberculosis
Prevention (NCHSTP)—CDC offers an array of scientific and financial
support for state infectious diseases surveillance, prevention, and control
programs. NCID officials said that most of their 1,100 staff and $186 million
budget in fiscal year 1998 were devoted to assisting state infectious
diseases efforts. For example, CDC provides testing services and
consultation not available at the state level; training on infectious diseases



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                           and laboratory topics, such as testing methods and outbreak
                           investigations; and grants to help states conduct diseases surveillance.4
                           The Epidemiology Program Office provides training and technical
                           assistance related to software for disease reporting and oversees data
                           integration efforts.


Laboratories Play an       Public health and private laboratories are a vital part of the surveillance
Essential Role in          network because only laboratory results can definitively identify
Surveillance of Emerging   pathogens. In addition, they often are an essential complement to a
                           physician’s clinical impressions. According to public health officials, the
Infectious Diseases        nation’s 158,000 laboratories are consistent sources of passively reported
                           information for infectious diseases surveillance.5 Independent commercial
                           and hospital laboratories may also share with public health agencies
                           information gathered through their private surveillance efforts, such as
                           studies of patterns of antibiotic resistance or the spread of diseases within
                           a hospital.

                           Every state has at least one state public health laboratory to support its
                           infectious diseases surveillance activities and other public health
                           programs. Some states operate one or more regional laboratories to serve
                           different parts of the state. In five states—Iowa, Nebraska, Nevada, Ohio,
                           and Wisconsin—academic institutions, such as university medical schools,
                           provide public health laboratory testing. State laboratories conduct testing
                           for routine surveillance or as part of special clinical or epidemiologic
                           studies. These laboratories provide diagnostic tests for rare or unusual
                           pathogens that are not always available in commercial laboratories or tests
                           for more common pathogens that use new technology still needing
                           controlled evaluation. State public health laboratories provide specialized
                           testing for low-incidence, high-risk diseases, such as tuberculosis and
                           botulism. Testing they provide during an outbreak contributes greatly to
                           tracing the spread of the outbreak, identifying the source, and developing
                           appropriate control measures. Epidemiologists rely on state public health
                           laboratories to document trends and identify events that may indicate an
                           emerging problem. Many state laboratories also provide licensing and
                           quality assurance oversight of commercial laboratories.


                           4
                           The grants discussed in this report are cooperative agreements in which CDC helps direct and
                           monitor funded activities.
                           5
                            U.S. laboratories include about 90,000 laboratories in physicians’ offices; 5,800 independent clinical
                           laboratories; 9,000 hospital laboratories; and 53,000 other laboratories, such as those in state and local
                           health departments, nursing homes, and other health care facilities. In 1993, about 60 percent of the
                           nation’s approximately 3,000 local health departments provided at least some laboratory services,
                           often for a limited number of diseases.



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                       State public health laboratories are increasingly able to use new advanced
                       molecular technology to identify pathogens at the molecular level. Often,
                       these tests provide information that is used not to diagnose and treat
                       individual patients but to tell epidemiologists whether cases of illness are
                       caused by the same strain of pathogen—information that is not available
                       from clinical records or other conventional epidemiologic methods. Public
                       health officials have already used this type of laboratory information to
                       identify the movement of diseases through a community in ways that
                       would not have been possible 5 years ago. For example, staff in
                       Minnesota’s laboratory use a molecular technology called pulsed field gel
                       electrophoresis (PFGE) to test “isolates” (isolated quantities of a pathogen)
                       of E. coli O157:H7 that laboratories in the state must submit. From 1994 to
                       1995, the resulting DNA fingerprint patterns identified 10
                       outbreaks—almost half of which would not have been identified by
                       traditional surveillance methods. Using the laboratory results,
                       epidemiologists were able to find the sources of contamination and
                       eliminate them, thus preventing additional infections.

                       CDC  laboratories provide highly specialized tests not always available in
                       state public health or commercial laboratories and assist states with
                       testing during outbreaks. The staff at CDC’s laboratories also have a broad
                       range of expertise identifying pathogens. These laboratories help diagnose
                       life-threatening, unusual, or exotic infectious diseases; provide
                       information on cases of infectious diseases for which satisfactory tests are
                       not widely or commercially available; and confirm public or private
                       laboratory test results that were atypical or difficult to interpret.
                       According to NCID officials, CDC laboratories provide testing services and
                       consultations on conducting tests or interpreting results to every state. CDC
                       also conducts research to develop improved diagnostic methods and trains
                       state laboratory staff to use them.


                       While state surveillance and laboratory testing programs are extensive, not
Not All States         all include every significant emerging infectious disease, leaving gaps in
Conduct Surveillance   the nation’s surveillance network. Each state decides which diseases it
and Testing for        includes in its surveillance program and which diseases it routinely
                       reports to CDC. Many state epidemiologists believe their surveillance
Important Emerging     programs need to add or focus more attention on important infectious
Infections             diseases, including hepatitis C and antibiotic-resistant diseases. Our survey
                       found that almost all states conduct surveillance of E. coli O157:H7,
                       tuberculosis, pertussis, and hepatitis C, but fewer collect information on
                       cryptosporidiosis and penicillin-resistant S. pneumoniae. State public



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                         health laboratories commonly perform tests to support state surveillance
                         programs for E. coli O157:H7, tuberculosis, pertussis, and
                         cryptosporidiosis. Most, however, do not test for hepatitis C and
                         penicillin-resistant S. pneumoniae. Slightly more than half the state
                         laboratories use PFGE, which state and CDC officials believe could be
                         valuable to most or all states’ diseases surveillance efforts. Few states
                         have followed CDC’s suggestion to improve surveillance by requiring
                         medical providers and laboratories to routinely submit specimens for
                         testing in state public health laboratories.


States Determine Which   Each year, the Council of State and Territorial Epidemiologists (CSTE), in
Diseases Are Under       consultation with CDC, reviews the list of infectious diseases that are
National and State       “nationally notifiable”—that is, important enough for the nation as a whole
                         to merit routine reporting to CDC. The list currently includes 52 infectious
Surveillance             diseases.6 States are under no obligation to adopt the nationally notifiable
                         diseases for their own surveillance programs, and state reporting to CDC is
                         voluntary. A 1997 CSTE survey of state health departments found that
                         87 percent of states included at least 80 percent of the 52 nationally
                         notifiable diseases in their surveillance programs, and about one-third of
                         states included over 90 percent.7 Lists of state reportable diseases vary
                         considerably, partly because of differences in the extent to which diseases
                         occur in different regions of the country.8


Surveillance of Some     Of the six diseases covered by our survey, nearly all the states include at
Diseases Is Not          least four in their diseases surveillance—most commonly tuberculosis, E.
Widespread               coli O157:H7, pertussis, and hepatitis C. A slightly smaller number of states
                         include cryptosporidiosis in their surveillance programs.
                         Penicillin-resistant S. pneumoniae was covered least often, with about
                         two-thirds of the states including it. For all of the diseases except
                         penicillin-resistant S. pneumoniae, most states require health care
                         providers, laboratories, and others to submit disease reports to public
                         health officials. These reports contain information such as demographic
                         characteristics of the ill person, the date disease symptoms appeared, and
                         the suspected or confirmed diagnosis. (See fig. 1.)


                         6
                          State and CDC officials periodically revise the list of nationally notifiable diseases.
                         7
                          Survey results did not include information from the District of Columbia and three of the territories.
                         8
                          States also request or require reporting of diseases of local importance that are not on the list of
                         nationally notifiable diseases. The 1997 survey revealed that a total of 74 other infectious diseases
                         were each included in the surveillance program of at least one state.



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Figure 1: State Surveillance of Selected Emerging Infections: Diseases Included, Reporting Requirements, and State Public
Health Laboratory Testing
Respondents
 60
       55 54             54               54
             53                                52                              52
                                   51
 50                                                 49
                              46                              46                    47
                                                                   43
                                                                        40
 40                                                                                               37

 30
                                                                                                       26
                                                                                         22
 20                                                                                                         19


 10


  0
       Tuberculosis   E. coli O157:H7      Pertussis      Cryptosporidiosis   Hepatitis C     Penicillin-Resistant
                                                                                              S. pneumoniae

         State Conducts Surveillance
         State Requires Reports
         State Laboratory Tests for Surveillance


                                                    Note: State surveillance and reporting requirement data include 55 states; state laboratory testing
                                                    data include 54 states that provided complete data.


                                                    Over three-quarters (44) of the responding epidemiologists told us that
                                                    their surveillance programs either leave out or do not focus sufficient
                                                    attention on important infectious diseases. Antibiotic-resistant diseases,
                                                    including penicillin-resistant S. pneumoniae, and hepatitis C were among
                                                    the diseases they cited most often as deserving greater attention.9




                                                    9
                                                     The epidemiologist in one state reported taking steps to add hepatitis C and penicillin-resistant S.
                                                    pneumoniae to the state’s list of reportable diseases. Another state epidemiologist reported adding
                                                    hepatitis C to the list of reportable diseases, and a third reported adding penicillin-resistant S.
                                                    pneumoniae.



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State Public Health       State laboratory testing to support state surveillance of the six emerging
Laboratory Testing Does   infections in our survey varies across the nation. Testing is most common
Not Always Accompany      for four of the six: tuberculosis, E. coli O157:H7, pertussis, and
                          cryptosporidiosis (see fig. 1). In 43 of the 54 state responses we analyzed,10
Surveillance              the state public health laboratory conducts testing for four or more of the
                          diseases included in its state’s surveillance program.11 Testing to support
                          state surveillance of hepatitis C and penicillin-resistant S. pneumoniae
                          occurs in fewer than half of the states.

                          State and CDC officials believe that most, and possibly all, states should
                          have PFGE technology, which can be used to study many diseases and
                          greatly improves the ability to detect outbreaks. However, for the diseases
                          we asked about in our survey, state public health laboratories are less
                          likely to use advanced molecular technology than more conventional
                          techniques. For example, slightly more than half the state laboratories
                          reported using PFGE technology to support state surveillance efforts.
                          Twenty-nine of the 54 laboratory directors responding to our survey
                          reported using PFGE to support E. coli O157:H7 surveillance, and nine of
                          these laboratories also use it for pertussis surveillance.

                          If a state laboratory provided testing in support of state-level surveillance
                          of a specific disease, we asked directors to assess the adequacy of their
                          testing equipment for that disease. Laboratory directors’ views about the
                          adequacy of the testing equipment they use varied somewhat by disease
                          but were generally positive. Eighty percent or more of the laboratory
                          directors rated their equipment as generally or very adequate for four
                          diseases—tuberculosis, E. coli O157:H7, cryptosporidiosis, and hepatitis
                          C. Percentages were slightly lower for pertussis (69 percent) and
                          penicillin-resistant S. pneumoniae (68 percent).12




                          10
                            To study the full range of state surveillance, reporting, and testing efforts for the conditions we asked
                          about, we paired the responses of laboratory directors and epidemiologists by state. For these data, we
                          analyzed only the responses of the 54 pairs of epidemiologists and laboratory directors who provided
                          complete information. We excluded the two states where only the laboratory director responded and
                          the one state where the laboratory director did not provide complete information on surveillance
                          testing.
                          11
                           The 11 other state laboratories conduct tests for one or more of these six infectious diseases. In some
                          cases, the laboratory tests three or fewer of the diseases as part of the state’s surveillance efforts; in
                          others, the laboratory tests on behalf of other public or private laboratories.
                          12
                           These results exclude laboratories that do not provide surveillance-related testing for the specific
                          disease.



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                        State epidemiologists’ views about the adequacy of the testing information
                        provided by state laboratories vary considerably by disease.13 More than
                        94 percent rated their state laboratory as very or generally adequate to
                        provide testing information for tuberculosis and E. coli O157:H7. More
                        than 70 percent said their state laboratory is generally or very adequate for
                        generating information on pertussis and cryptosporidiosis. In contrast,
                        only about one-third of epidemiologists said the information generated by
                        their state laboratory for hepatitis C (32 percent) and penicillin-resistant S.
                        pneumoniae (37 percent) is generally or very adequate.

                        We also found that many states do not require other public and private
                        laboratories or medical providers to submit to the state public health
                        laboratory specimens or isolates from persons with certain diseases. CDC
                        has urged states to consider developing such laws because gathering
                        specimens from across the state helps ensure that the state’s surveillance
                        data include a diverse sample of the state’s population. Such action by
                        states also contributes to more comprehensive national data. In all, 29
                        states require specimens for one or more of the six diseases in our survey:
                        5 states require specimens for four diseases, 4 states require specimens for
                        three diseases, 9 states for two, and 11 for one disease.14 Specimens of
                        tuberculosis and E. coli O157:H7 are required most frequently.


                        As part of our survey and field interviews, we asked state officials to
Officials Report That   identify the problems they considered most significant in conducting
Staffing Constraints    surveillance of emerging infectious diseases. The problems they cited fall
and Weak Information    principally into two categories: staffing and information sharing. State
                        epidemiologists reported that staffing constraints prevent them from
Sharing Impede          undertaking surveillance of diseases they consider important. Laboratory
Surveillance of         directors told us they do not always have enough staff to conduct tests
                        needed for surveillance; furthermore, their staff need training to remain
Emerging Infections     current with technological advances. Epidemiologists and laboratory
                        officials both said that public health officials often lack either basic
                        computer equipment or integrated data systems that would allow them to
                        rapidly share surveillance-related information with public and private
                        partners.


                        13
                          If testing by the state laboratory was part of state-level surveillance of a specific disease, we asked
                        state epidemiologists to assess the state laboratory’s adequacy in generating the data needed for
                        surveillance.
                        14
                         Twenty-two states require no specimens but ask for voluntary submission of specimens for one or
                        more of the six diseases, usually for special studies rather than routinely. Three states neither require
                        nor ask that specimens of these diseases be sent to their state public health laboratory.



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Staffing and Training                         Public health officials reported that the nation’s infectious diseases
Limitations Affect Ability                    surveillance system is basically sound but could improve its ability to
to Expand Laboratories’                       detect emerging threats. Most state officials believe they need to expand
                                              their infectious diseases surveillance programs. However, both state
Role                                          laboratory directors and epidemiologists said that such expansion has
                                              been constrained by staffing and training limitations. Most of the 44
                                              epidemiologists who reported that they need to expand coverage of
                                              important infectious diseases said insufficient staff and funding resources
                                              prevent them from taking this action. Some noted that they need more and
                                              better trained staff just to do a better job on diseases already included in
                                              their programs.

                                              We found considerable variability among states in laboratory and
                                              epidemiology staffing per 1 million population. In total, we found that
                                              during fiscal year 1997, states devoted a median of 8 staff years per
                                              1 million population to laboratory testing of infectious diseases.
                                              Laboratory staff year medians for individual types of testing ranged from
                                              0.4 for foodborne pathogens to 2.4 for all other infectious diseases not
                                              specifically listed in table 1. The median for total epidemiology staff years
                                              per 1 million population was 14; the range was from 0.1 for foodborne
                                              pathogens to 5 for HIV/AIDS. (See table 1.)


Table 1: State Public Health Laboratory and Epidemiology Staff Years Per 1 Million Population in Fiscal Year 1997
                                                                                                          Epidemiology staff
                                                                               Laboratory staff years            years
Disease or condition                                                                          Median          Range          Median          Range
Tuberculosis                                                                                       1.2           0-21             1.8           0-45
         a
HIV/AIDS                                                                                             1         0.2-33             5.1         0-193
Sexually transmitted diseases                                                                      1.4         0.1-50             3.3           0-72
Foodborne diseases                                                                                 0.4           0-17             0.1           0-33
Other emerging infectious diseases                                                                 0.7           0-14             0.2           0-33
All other infectious diseases                                                                      2.4           0-16             3.2           0-50
Total staff years devoted to infectious diseases programs                                          8.1         1.3-89              14       2.1-321
                                              a
                                               HIV/AIDS was excluded from the “other emerging infectious diseases” category.



                                              The majority of state laboratory directors indicated that their staffing
                                              resources are generally adequate to generate test results for the diseases
                                              in our study.15 For each of the four diseases that state laboratories most

                                              15
                                               This represents the views of laboratory directors whose staff conduct tests to support surveillance of
                                              at least one of the diseases we asked about.



                                              Page 13                          GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
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                        commonly support, more than 75 percent of directors rated their staff as
                        generally or very adequate to perform the tests.16 Among the smaller
                        number of state laboratories that conduct tests to support surveillance of
                        hepatitis C and penicillin-resistant S. pneumoniae, a smaller percentage of
                        laboratory directors considered their staff resources at least adequate
                        (68 percent and 58 percent, respectively).

                        Some state laboratory and epidemiology officials told us that staffing
                        constraints prevent them from making full use of testing capacity. For
                        example, the laboratory director in a state that had acquired PFGE
                        technology cited lack of staff time as one reason for not routinely using
                        PFGE in surveillance of E. coli O157:H7. As a result, he said, the incidence
                        of E. coli O157:H7 in his state is probably understated. If resources were
                        available, he would also like laboratory staff to test pertussis specimens
                        collected during a recent outbreak to determine whether the increase in
                        reported cases was a true outbreak or the result of increased
                        awareness—and reporting—of the disease following the death of a child.
                        Thirty-six state laboratory directors reported having vacancies during the
                        past year and said the vacancies had negatively affected their laboratory’s
                        ability to support their state’s infectious diseases surveillance activities.
                        Nine rated the impact as great or significant. Administrative and financial
                        constraints, such as hiring freezes or budget reductions, were most often
                        responsible for the vacancies.

                        Laboratory officials noted that advances in scientific knowledge and the
                        proliferation of molecular testing methods have created a need for training
                        to update the skills of current staff. They reported that such training is
                        often either unavailable or inaccessible because of funding or
                        administrative constraints. For example, several state officials said that in
                        reducing costs, training budgets are often cut first. In other states, staff are
                        subject to per capita limits on training or travel expenses. Therefore, if CDC
                        or another source provided additional funding, these funds could not be
                        used.


Lack of Equipment and   For health crises that need an immediate response—as when a serious and
Cumbersome Systems      highly contagious disease appears in a school or among restaurant
Hinder Information      staff—rapid sharing of surveillance information is critical. Public health
                        officials told us, however, that many state and local health departments do
Sharing                 not have the basic equipment to efficiently share information across the


                        16
                          The specific percentages for the four diseases are E. coli O157:H7 (82 percent), tuberculosis
                        (75 percent), pertussis (78 percent), and cryptosporidiosis (77 percent).



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surveillance network. Computers and other equipment, such as answering
or fax machines, that can shorten the process of sharing surveillance
information from weeks to a day or less are not always available.

Our survey responses indicate that state laboratory directors use
electronic communication systems much less often than state
epidemiologists use them. Although about three-quarters of responding
state laboratory directors use electronic systems to communicate within
their laboratories, they do not frequently use electronic systems to
communicate with others. Almost 40 percent of laboratory directors
reported using computerized systems to little or no extent for receiving
surveillance-related data, and 21 percent use them very little for
transmitting data. While state epidemiologists use electronic systems more
than laboratory directors, they also use them less commonly to receive
information (42 percent) than to report it (62 percent).

One reason for the limited use of electronic systems may be the lack of
equipment. A 1996 CDC survey found that, on average, about 20 percent of
staff in most state health agencies did not have access to desktop
computers that were adequate for sharing information rapidly. Forty
percent of local health officials responding to a 1996 survey conducted by
the National Association of City and County Health Officials said they
lacked such equipment.17 State and local health officials most often
attributed the lack of computer equipment and integrated data processing
and management systems to insufficient funding.

The absence of equipment means some tasks that could be automated
must be done by hand—and in some cases must be done by hand even
after data have already been processed in electronic form. For example,
representatives from two large, multistate private clinical laboratories told
us that data stored electronically in their information systems had to be
converted to paper so that it could be reported to local health
departments. In one state we visited, a local health department mails data
stored on disk to the state health agency because it lacks the equipment to
transfer the data electronically.

Even with adequate computer equipment, the difficulty of creating
integrated information systems can be formidable. Not only does
technology change rapidly, but public health data are currently stored in
thousands of places, including the record and information systems of

17
  Questionnaires were mailed to a random sample of 800 health officials in local health agencies; 384
responded.



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                           public health agencies and health care institutions, individual case files,
                           and data files of surveys and surveillance systems. These data are in
                           isolated locations that have differing hardware and software structures
                           and considerable variation in how the data are coded, particularly for
                           laboratory test results.

                           CDC  operates over 100 data systems to monitor over 200 health events,
                           such as specific infectious diseases. Many of these systems collect data
                           from state surveillance programs. This patchwork of data systems arose,
                           in part, to meet CDC and state needs for more detailed information for
                           particular diseases than was usually reported. For example, while
                           information collected to determine incidence rates of many nationally
                           notifiable diseases consists of minimal geographic and demographic data,
                           the information collected to determine incidence rates of tuberculosis
                           includes information on personal behavior, the presence of other diseases,
                           and stays in institutional settings, as well as geographic and demographic
                           data. The additional information collected on tuberculosis also helps guide
                           prevention and control strategies.

                           Public health officials told us that the multitude of databases and data
                           systems, software, and reporting mechanisms burdens staff at state and
                           local health agencies and leads to duplication of effort when staff must
                           enter the same data into multiple systems that do not communicate with
                           one another. Furthermore, the lack of integrated data management
                           systems can hinder laboratory and epidemiologic efforts to control
                           outbreaks. For example, in 1993 the lack of integrated systems impeded
                           efforts to control the hantavirus outbreak in the Southwest. Data were
                           locked into separate databases that could not be analyzed or merged with
                           others, requiring public health investigators to analyze individual paper
                           printouts.


Other Concerns May Also    State officials also raised concerns about a lack of complete data for
Affect Use of Laboratory   surveillance and the increased reliance on fees to fund state laboratories,
Data                       which they believe undermine their infectious diseases surveillance
                           efforts.

Completeness of Data       Public health officials and experts acknowledge that, even when states
                           require reporting, the completeness of data reported varies by disease and
                           type of provider. As might be expected, reporting of severe and
                           life-threatening diseases is more complete than reporting of mild diseases.
                           However, when mild diseases are not reported, outbreaks affecting a large



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number of people may go unnoticed until deaths occur among people at
higher than normal risk. In addition, reporting by practitioners in frequent
contact with infectious diseases, such as family practitioners, is more
complete than reporting by those who are not, such as surgeons. Although
surveillance need not be complete to be useful, underreporting can
adversely affect public health efforts by leading to erroneous conclusions
about trends in incidence, risk factors for contracting a disease,
appropriate prevention and control measures, and treatment effectiveness.

Completeness of reporting is a concern for the surveillance of illnesses
that can produce mild symptoms, such as diarrheal illnesses, which
include many foodborne and waterborne conditions. Reported cases of
some illnesses represent the tip of the iceberg, at best. A recent
CDC-sponsored study estimated that 340 million annual episodes of acute
diarrheal illness occurred in the United States, but only 7 percent of
people who were ill sought treatment. The study further estimated that
physicians requested laboratory testing of a stool culture for 22 percent of
those patients who sought treatment, which produced about 6 million test
results that could be reported.18 In cases of mild diarrheal illness,
physicians may not request laboratory tests to identify the pathogen
because patients with these diseases can get better without treatment or
effective treatments do not exist.

Public health officials expressed varying views about how managed care
growth and the consolidation of the laboratory industry might affect the
completeness of surveillance data. Some public health officials and
physicians believe that managed care—with its emphasis on controlling
costs—could lead doctors to order fewer diagnostic tests, particularly
those not needed for treatment decisions. Also, to the extent that managed
care organizations less frequently use specialists, results from specialized
tests they employ would not be generated. Concerns about laboratory
consolidation—particularly when specimens are shipped to central testing
facilities in other states—stem from fears that out-of-state testing centers
will not report test results needed for surveillance, possibly because they
might not be aware of state reporting requirements regarding what
information should be reported and where to direct it. In two states we
visited, representatives of large multistate independent laboratories said
their policy is to report test results in accordance with state requirements.
One representative provided us with documentation showing the various
reporting requirements of states in one region served by the laboratory.

18
 H. Herikstad and others,”Population-Based Estimates of the Burden of Diarrheal Illness: FoodNet
1996-1997” (Atlanta, Ga.: International Conference on Emerging Infectious Diseases, 1998).



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                                Each of these laboratories is participating in electronic laboratory
                                reporting pilot programs in different states.

                                Other CDC and state public health officials believe that managed care
                                organizations and concentrated ownership of laboratories could provide
                                information that is potentially more consistent, complete, and reliable than
                                what public health officials now routinely obtain through passive
                                reporting. They argue that because information on a large number of
                                patients is concentrated in a small number of organizations, the number of
                                contacts for active surveillance projects is smaller and more manageable
                                and information can be analyzed from large databases. Moreover, they
                                add, these organizations are likely to collect and store laboratory data
                                electronically, which could speed disease reporting.

                                Our survey asked epidemiologists whether they or other agencies in their
                                states had evaluated the impacts of managed care and laboratory
                                consolidation on surveillance data; we could identify no systematic
                                evaluations on this issue. Similarly, researchers who conducted a survey
                                for HHS did not find data that address concerns about the impact of
                                managed care.19

Increased Reliance on Fees to   Another concern state officials frequently mentioned is an increasing
Fund State Laboratories         reliance on fees to fund the operations of state public health laboratories.
                                Over 30 laboratory directors responding to our survey said their budgets
                                were partly supported by fees for genetic screening and tests for
                                regulatory and licensure programs. State officials told us that an
                                imbalance of fees in relation to appropriated funding shifts the focus of
                                laboratory operations away from testing services beneficial to the entire
                                community and toward services that can be successfully marketed—a
                                shift that they believe could jeopardize fulfilling their public health
                                mission. One state laboratory director said that over the past 15 years,
                                state funding has declined by more than half and fees are expected to
                                cover the difference. He believes that if the laboratory loses contracts for
                                genetic or blood lead-level testing, he will have to reduce other testing,
                                such as for sexually transmitted diseases or CDC’s influenza surveillance.




                                19
                                  Public Health Laboratories and Health System Change, The Lewin Group, Oct. 6, 1997.



                                Page 18                         GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
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No Public Health         Although many state officials are concerned about their staffing and
Consensus Defines Core   technology resources, public health officials have not developed a
Capacities Needed for    consensus definition of the minimum capabilities that state and local
                         health departments need to conduct infectious diseases surveillance. For
Surveillance System      example, according to CDC and state health officials, there are no
                         standards for the types of tests state public health laboratories should be
                         able to perform; nor are there widely accepted standards for the
                         epidemiological capabilities state public health departments need. Public
                         health officials have identified a number of elements that might be
                         included in a consensus definition, such as the number and qualifications
                         of laboratory and epidemiology staff; the pathogens that each state
                         laboratory should be able to identify and, where relevant, test for
                         antibiotic resistance; specialized laboratory and epidemiology capability
                         that should be available regionally; laboratory and information-sharing
                         technology each state should have; and support services that CDC should
                         provide.

                         Recognizing this lack of guidance, CSTE, the Association of Public Health
                         Laboratories (APHL), and CDC have begun collaborating to define the staff
                         and equipment components of a national surveillance system for
                         infectious diseases and other conditions. Their work is to include
                         agreements about the laboratory and epidemiology resources needed to
                         conduct surveillance, diseases that should be under surveillance, and the
                         information systems needed to share surveillance data. One goal of
                         reaching this consensus would be to give state and local health agencies
                         the basis for setting priorities for their surveillance efforts and determining
                         the resources needed to implement them.


                         CDC  provides state and local health departments with a wide range of
CDC Services Are         technical, financial, and staff resources to help maintain or improve their
Wide-Ranging and         ability to detect and respond to disease threats. Many state laboratory
Generally Perceived      directors and epidemiologists said this assistance has been essential to
                         their ability to conduct infectious diseases surveillance and to take
as Valuable              advantage of new laboratory technology. However, a small number of
                         laboratory directors and epidemiologists believe CDC’s assistance has not
                         added much to their ability to conduct surveillance of emerging infections,
                         and many state officials indicated that further improvements are needed,
                         particularly in the area of information-sharing systems.




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Services Include Both         CDC’s various units, particularly NCID, provide an array of technical and
Technical and Financial       financial support for state infectious diseases surveillance programs. In
Assistance                    general, this support falls into the following six areas: testing and
                              consulting, training, grant assistance, funding for regional laboratories,
                              staffing assistance, and information-sharing systems.

                          •   Laboratory testing and consultation. CDC staff and laboratories support
                              state infectious diseases surveillance efforts with technical assistance and
                              testing services that may not be available at the state level. CDC staff
                              provide consultation services on such matters as epidemiological methods
                              and analysis, laboratory techniques, and interpretation of laboratory
                              results. Almost all of the state laboratory directors and epidemiologists
                              responding to our survey said they use CDC’s laboratory testing services
                              and frequently consult with CDC staff.
                          •   Training. CDC provides public health and medical personnel with training
                              on a wide range of topics. The training is offered through such means as
                              interactive audio- or video-conferences, computer-assisted instruction,
                              seminars, and hands-on workshops. Since 1989, CDC has offered laboratory
                              training through a collaboration with APHL. An APHL and CDC assessment
                              identified the need for training on current advances in food microbiology,
                              fungal and viral infections, rabies, tuberculosis, and new and emerging
                              pathogens. To meet these needs, CDC developed a series of courses
                              incorporating hands-on experience, offered in various locations around
                              the country. State laboratory directors and epidemiologists indicated they
                              use CDC training extensively, and most said they participated in
                              CDC-sponsored training in 1997.
                          •   Grant programs. CDC’s various grant and staffing assistance programs
                              provide at least some support to the infectious diseases surveillance
                              programs of all states. In fiscal year 1998, NCID distributed $31.2 million of
                              its $185.7 million budget to state and local health agencies for infectious
                              diseases programs. NCID supports three major grant programs that aid state
                              surveillance programs for emerging infectious diseases (see table 2).20
                              Together these three grant programs provided about $20 million to state
                              and local health departments in fiscal year 1997.




                              20
                               CDC’s NCHSTP provides grants that aid state surveillance of HIV/AIDS, sexually transmitted
                              diseases, and tuberculosis.



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Table 2: NCID’s Grant Assistance for State Infectious Diseases Programs During Fiscal Year 1997
Program description                                       FY 1997 funding                  1997 recipients
Tuberculosis grants
Helps state laboratories improve their testing ability to        $9.6 million, with awards ranging          All 50 states, Los Angeles, and New
support state tuberculosis surveillance and elimination          from $8,000 to $1.3 million                York City
efforts.
Emerging Infections Program (EIP) grants
Helps states improve their surveillance of emerging          $5.8 million, with annual awards               California, Connecticut, Georgia,
infections and produce information of national significance. ranging from $645,000 to $1.2                  Maryland, Minnesota, New York,
States have used funds for active surveillance of            million                                        Oregon
drug-resistant infections, foodborne and waterborne
diseases, and vaccine-preventable conditions; to conduct                                                    (CDC intends to add 3 states by
applied research on epidemiologic and laboratory                                                            2000, bringing the total to 10.)
methods; and to implement prevention projects. CDC
began EIP with funding for programs in four states.
Epidemiology and Laboratory Capacity (ELC) grants
Helps states and large local health departments strengthen $4.3 million, with awards ranging                California, Colorado, Florida,
and enhance their basic capacity for surveillance of and   from $128,000 to $379,000                        Georgia, Hawaii, Illinois, Kansas,
response to infectious diseases. Funds allow states to                                                      Louisiana, Maine, Massachusetts,
implement new technology, upgrade information systems,                                                      Michigan, New Jersey, New York,
hire and train staff, and purchase office and laboratory                                                    New York City, Ohio, Pennsylvania,
equipment. Projects include building electronic reporting                                                   Tennessee, Utah, Vermont,
systems; using molecular laboratory methods in outbreak                                                     Washington, West Virginia, Wisconsin
investigations; and enhancing surveillance of hepatitis C,
diarrheal illnesses, and other conditions. CDC awarded                                                      (CDC added 8 states in 1998 and
ELC grants initially to 10 states.                                                                          plans to involve all 50 state health
                                                                                                            departments as well as many
                                                                                                            territorial and large local health
                                                                                                            departments by 2002.)

                                                 EIP and ELC grants, designed to strengthen and enhance state surveillance
                                                 abilities, are components of CDC’s overall plan to address emerging
                                                 infectious diseases.21

                                             •   Funding for regional laboratory networks. To help with both state-specific
                                                 and nationwide control and prevention efforts, CDC has sponsored
                                                 development of regional laboratory networks that give states access to
                                                 molecular testing services that may not be available in their own state
                                                 laboratory. The two main laboratory networks are PulseNet, which
                                                 currently focuses on E. coli O157:H7, and the Tuberculosis Genotyping
                                                 Network (see table 3).




                                                 21
                                                   Centers for Disease Control and Prevention, Preventing Emerging Infectious Diseases: A Strategy for
                                                 the 21st Century (Atlanta, Ga.: Department of Health and Human Services, Sept. 1998).



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Table 3: CDC-Sponsored Regional Laboratory Networks
Description                             Laboratories participating                                 Notable results
PulseNet
EIP and ELC funding helped build PulseNet,      In 1998, the network included 4 state              In 1997, Colorado’s public health
a laboratory network that uses PFGE to study    public health laboratories that provide            laboratory, using PFGE to develop DNA
E. coli O157:H7. Salmonella typhimurium         testing to nearby states, 20 public health         fingerprints of E. coli O157:H7 isolates
and other non-typhoidal Salmonella were         laboratories that test specimens from within       submitted from laboratories in the state,
recently added to the organisms under           their borders, and U.S. Department of              found identical fingerprint patterns in
study; more will be added in the future.        Agriculture (USDA) and Food and Drug               samples from 13 different patients.
Participating laboratories are electronically   Administration laboratories that test food         Subsequent testing at a USDA laboratory
linked to rapidly share PFGE patterns of        products.                                          matched the fingerprints with those of E.
foodborne pathogens for comparison.                                                                coli O157:H7 isolates recovered from
                                                                                                   ground beef taken from packages used by
                                                                                                   two of the patients. State officials
                                                                                                   concluded the cases were linked to the
                                                                                                   meat, which had been distributed
                                                                                                   nationally. The manufacturer, in
                                                                                                   cooperation with federal officials, removed
                                                                                                   25 million pounds of potentially
                                                                                                   contaminated ground beef from U.S.
                                                                                                   markets.
Tuberculosis Genotyping Network
This network of enhanced tuberculosis           CDC selected seven regional laboratories           CDC and participating laboratories
surveillance uses restriction fragment length   in April 1996. In 1997, CDC gave these             established a national database of
polymorphism—a DNA fingerprint                  laboratories a total of over $900,000.             tuberculosis fingerprints. Patterns in the
technology—to trace the spread of specific                                                         database showed that drug-resistant
strains of the disease. The laboratories also                                                      strains first found in New York City have
help states investigate outbreaks and                                                              spread to other parts of the country. The
identify instances of laboratory                                                                   fingerprints also showed that tuberculosis
contamination that resulted in false                                                               can be transmitted during brief contact
diagnoses.                                                                                         among people who do not work or live
                                                                                                   together, an important discovery that led to
                                                                                                   improved treatment and control programs.

                                            •   Staffing assistance. CDC provides a small number of staff resources to
                                                assist state infectious diseases programs through 2-year Epidemic
                                                Intelligence Service (EIS) placements and fellowships in state or local
                                                health departments or laboratories. About one-fourth of the 60 to 80 EIS
                                                participants selected each year work in state and local health departments.
                                                Additionally, by February 1998, CDC had trained 18 laboratory fellows to
                                                work in state, local, and federal public health laboratories through its
                                                Emerging Infectious Diseases Laboratory Fellow Program, a collaborative
                                                effort with APHL; CDC plans to make 9 emerging diseases laboratory
                                                fellowships available through APHL and the CDC Foundation.22 One goal of
                                                the fellowships is to strengthen the relationship of public health


                                                22
                                                 The CDC Foundation is a nonprofit corporation established under the authority of the Preventive
                                                Health Amendments of 1992 (42 U.S.C. section 280 d-11) to support CDC’s mission.



                                                Page 22                         GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
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                                  laboratories to infectious diseases and drug-resistance surveillance,
                                  prevention, and control efforts.
                              •   Information sharing. Over the past several decades, CDC has developed and
                                  made available to states several general and disease-specific information
                                  management and reporting programs. Virtually all states use two of these
                                  programs to report data on some infectious diseases to CDC—the Public
                                  Health Laboratory Information System (PHLIS) and the National Electronic
                                  Telecommunications System for Surveillance (NETSS). PHLIS is used
                                  primarily by laboratories; NETSS is used primarily by epidemiology
                                  programs.


State Officials Value CDC’s       Our surveys showed that overall state laboratory directors and
Assistance but See a Need         epidemiologists highly value the support CDC provides for their
for Improvement in                surveillance efforts. Usage and satisfaction levels were highest in the areas
                                  of testing and consultation, training, and grant support. The area most
Information-Sharing               often identified as needing improvement was the development of
Systems                           information-sharing systems.

Laboratory Testing,               Many state laboratory directors and epidemiologists told us that CDC’s
Consultation, and Training        testing, consultation, and training services are critical to their surveillance
Assistance Are Viewed as          efforts. In all three areas of assistance, more than half of those responding
Critical                          to our survey indicated that the services greatly or significantly improved
                                  their state’s ability to conduct surveillance (see fig. 2). According to
                                  officials who spoke with us, CDC’s testing for unusual or exotic pathogens
                                  and the ability to consult with experienced CDC staff are important,
                                  particularly for investigating cases of unusual diseases. However, about
                                  15 percent of survey respondents said CDC’s testing services made only
                                  modest improvements in their state’s surveillance capacity.




                                  Page 23                  GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
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Figure 2: Views of State Laboratory
Directors and Epidemiologists on
Extent CDC’s Testing, Consultation,
                                        Testing                                       Consultation
and Training Improved Emerging
Infectious Diseases Surveillance
Ability


                                                    57%                                               61%




                                                                                                                      7%
                                                                15%

                                                   28%                                                 32%




                                        Training




                                                                                            Greatly or Significantly Improved
                                                     65%
                                                                                            Moderately Improved

                                                                                            Somewhat or Slightly Improved

                                                                 11%


                                                          24%




                                      Over 70 percent of epidemiologists responding to our survey said that
                                      knowledgeable staff at CDC are easy to locate when they need assistance,
                                      but many noted that help with matters involving more than one CDC unit is
                                      very difficult to obtain. Many state officials who spoke with us thought
                                      that this problem arose because staff in different units do not seem to
                                      communicate well with each other. One official described CDC’s units as
                                      separate towers that do not interact.




                                      Page 24                     GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
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A number of state officials commented that CDC provides tests and
consultation very promptly when people are at risk—for example during
outbreaks of life-threatening diseases—but less quickly in other
circumstances. To provide more timely consultation, CDC has developed an
on-line image-sharing ability that allows CDC staff and health professionals
in remote locations to view an organism under a microscope at the same
time. In one state, staff at CDC and a surgeon in another state used this
capacity during an operation to identify a parasite as the cause of the
patient’s eye problem, allowing the surgeon to rule out cancer as a
diagnosis and eliminating the need to remove the patient’s eye.

Some state officials and survey respondents said that in less urgent
circumstances, CDC’s test results were often not returned quickly enough
to be useful to physicians or, in some cases, to epidemiologists. For
example, state officials have waited up to a year for CDC to return test
results on unusual organisms, making it difficult—if not impossible—to
recognize any subsequent encounters with these organisms. Some of these
officials suggested that competing priorities at CDC often prevented the
timely return of test results in the absence of immediate need.

Training is another CDC service that state officials believe is important. As
figure 2 shows, the percentage of respondents indicating that training
greatly or significantly improved their ability to conduct surveillance of
emerging infections was even higher than for testing and consultation.
Participant evaluations of recent courses offered in collaboration with
APHL were generally consistent with our survey results. These evaluations
indicated that the courses provided information the participants needed
on the most current technologies available. However, about 11 percent of
our survey respondents did not believe that the training they received
appreciably improved their surveillance ability.23

Although state officials generally valued the training CDC provides, they
also said more training is needed, especially hands-on, skill-based training
in new laboratory techniques. Laboratory officials in particular said that
the use of distance learning through audio- or video-conferences—as
opposed to hands-on workshops in CDC laboratories—diminished
opportunities to develop close collaboration between state and CDC
laboratory staff. According to CDC officials, the use of distance learning
became desirable when downsizing of staff in state public health

23
  The officials who considered the benefits from training moderate consisted of 29 percent of
responding laboratory directors and 19 percent of epidemiologists. The 11 percent who felt the
benefits were minimal represented 15 percent of responding epidemiologists and 6 percent of
laboratory directors.



Page 25                          GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
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                             laboratories and the costs of sending staff to Atlanta led to declining
                             attendance at courses at CDC headquarters. State officials also cited a need
                             for training and technical assistance in information-sharing systems.

Most Respondents See         Most state officials responding to our survey reported that funding
Substantial Value in Grant   through CDC’s disease-specific grants and epidemiology and laboratory
Assistance Programs          capacity grants had made great or significant improvements in their ability
                             to conduct surveillance for emerging infectious diseases (see fig. 3).24 Over
                             70 percent of responding laboratory directors and 80 percent of
                             responding epidemiologists—comprising more than three-quarters of all
                             survey respondents—said disease-specific funding had greatly or
                             significantly enhanced their state’s capacity to conduct infectious diseases
                             surveillance. With one exception, epidemiology, laboratory, and combined
                             capacity grants were similarly valued, with at least 68 percent of recipients
                             saying the enhancement was great or significant. Laboratory directors
                             reported benefitting more from grants specifically directed to laboratory
                             or combined laboratory and epidemiology capacity than from grants
                             specifically designed to enhance epidemiology capacity.




                             24
                              More states received disease-specific grant funding than epidemiology, laboratory, or combined
                             capacity building grants.



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Figure 3: Views of State Laboratory Directors and Epidemiologists on Extent CDC’s Funding Assistance Improved Efforts
to Use Laboratory Data in Emerging Infectious Diseases Surveillance


 Disease-Specific Grants                                 Epidemiology Capacity Grants




                                                                       68%

         78%

                           8%
                                                                                       11%


                     14%                                                      21%




 Laboratory Capacity Grants                             Combined Capacity Grants




           73%                                                        85%



                           9%                                                             6%

                                                                                     9%
                   18%




                                  Greatly or Significantly Improved
                                  Moderately Improved
                                  Somewhat or Slightly Improved

                                           Note: Sixty-five officials provided views on disease-specific grants, 28 provided views on
                                           epidemiology capacity grants, 34 on laboratory capacity, and 33 on combined capacity.




                                           Page 27                           GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
                                   B-280933




                                   Officials cited several examples in which CDC assistance was instrumental
                                   in helping states improve their surveillance and laboratory testing efforts
                                   for high-priority conditions, such as antibiotic-resistant diseases.

                               •   After state laboratories began receiving funds from CDC’s tuberculosis
                                   grant program, they markedly improved their ability to rapidly identify the
                                   disease and indicate which, if any, antibiotics could be used effectively in
                                   treatment. State laboratory officials attributed this improvement to the
                                   funding and training they received from CDC.
                               •   In addition to supporting such core activities as active surveillance of
                                   antibiotic-resistant conditions, four states use EIP funds to conduct active
                                   surveillance of unexplained deaths and severe illnesses in previously
                                   healthy people under age 50—a potentially critical source of information
                                   to detect new or newly emerging diseases. This project will also provide
                                   information on known infectious diseases that health care professionals
                                   are not recognizing in their patients. The epidemiologist in one of these
                                   states said that although reporting of such cases had been required for a
                                   long time, efforts to improve the completeness of the reporting and
                                   analyze the data began only after the state received CDC funds.

                                   Our survey provided one other possible indication of the effect of CDC’s
                                   assistance on state surveillance and testing for antibiotic-resistant
                                   conditions. In comparison to its funding for tuberculosis, which goes to
                                   programs in all states and selected localities, CDC funds active surveillance
                                   and testing for penicillin-resistant S. pneumoniae in only eight states. This
                                   pattern of funding parallels the pattern of testing reported by our survey
                                   respondents. Of the 54 states that reported conducting surveillance for
                                   tuberculosis, 49 have laboratories that test for antibiotic-resistance. In
                                   contrast, of the 37 states that reported conducting surveillance for
                                   penicillin-resistant S. pneumoniae, only about half have laboratories that
                                   provide testing support. Moreover, while all but one of the states require
                                   health care providers to submit tuberculosis reports to public health
                                   officials, fewer than half require reporting of penicillin-resistant S.
                                   pneumoniae.25

Regional Laboratory Networks       Although CDC-sponsored regional laboratory networks are intended to
Seen as Valuable, but Fewer        expand states’ access to advanced testing services, our survey responses
Than Half of States Use Them       indicate that only about half of the states have used these laboratories
                                   during the past 3 years. Among those state officials who did use the
                                   networks, views on their usefulness are generally favorable, although

                                   25
                                     In the 55 states where epidemiologists responded to our survey regarding their surveillance programs
                                   for the conditions we asked about, only 54 laboratory directors provided complete information on
                                   their testing to support state surveillance.



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                                                    B-280933




                                                    networks were not valued as highly as other types of assistance (see fig.
                                                    4). Of the 19 laboratory directors who used the services of regional
                                                    laboratories, 10 reported great improvement in their surveillance capacity
                                                    as a result, 6 reported moderate improvement, and the remaining 3 said
                                                    improvement was minimal. Of the 21 epidemiologists who used regional
                                                    laboratory services, 11 reported the services made great improvement, 5
                                                    said the improvement was moderate, and 5 said the improvement was
                                                    slight.



Figure 4: Views of State Laboratory Directors and Epidemiologists on Extent CDC’s Regional Laboratories Improved
Emerging Infectious Diseases Surveillance Ability


                                                                                                          11

    Epidemiologists                                            5

                                                               5



                                                                                                   10

Laboratory Directors                                                 6

                                             3


                       0           2               4               6               8             10            12
                                                       Number of Respondents


                           Greatly or Significantly Improved

                           Moderately Improved

                           Somewhat or Slightly Improved



                                                    Note: Officials are from 29 states.


Mixed Views on Staffing                             Almost two-thirds of the 33 epidemiologists and about half of the 13
Assistance                                          laboratory directors who had hosted CDC field placements reported that
                                                    their staff had greatly or significantly improved their program’s capacity to
                                                    conduct surveillance. State officials we spoke with generally highly
                                                    praised field placement programs because participants—who might




                                                    Page 29                            GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
                              B-280933




                              continue their careers in federal or state government—gained hands-on
                              experience working in state programs. An epidemiologist commented that
                              these placements, which spanned most of the past 20 years, had been
                              invaluable as they provided staff to supplement his state’s surveillance
                              program. One state official, however, said that the benefits of such
                              placements are limited because it takes almost 2 years of training for new
                              staff to effectively assist in state programs.

Information-Sharing Systems   According to officials who spoke with us, CDC’s information-sharing
Seen as Area Needing          systems have limited flexibility for adapting to state program needs—one
Considerable Improvement      reason many states have developed their own information management
                              systems to capture more or different data, they said. State and federal
                              officials told us that NETSS and PHLIS often cannot share data for reporting
                              or analysis with each other or with state- or other CDC-developed systems.
                              CDC officials responsible for these programs said that the most recent
                              versions can share data more readily with other systems but that the lack
                              of training in how to use the programs and high staff turnover at state
                              agencies may limit the number of state staff and officials able to use the
                              full range of program capabilities.

                              NETSS supports the collection and management of information such as
                              patient demographics and residence, the suspected or confirmed
                              diagnosis, and the date of disease onset. PHLIS contains more definitive
                              information on the pathogen provided by the laboratory test. Both
                              programs also offer optional disease-specific reporting modules states may
                              use to gather additional data. When epidemiologists cannot electronically
                              merge data from different sources, they must manually match the records
                              to analyze disease trends and determine the relevant risk factors needed
                              for effective prevention and control efforts. Sharing data between systems
                              also identifies multiple records on the same case and can help
                              epidemiologists take steps to improve reporting.

                              Epidemiologists responding to our survey rated NETSS more highly for
                              flexibility and overall helpfulness than laboratory directors rated PHLIS.
                              About half (48 percent) of responding epidemiologists said NETSS was
                              highly flexible for meeting their needs while only one-quarter (27 percent)
                              of laboratory directors said the same for PHLIS.26 Fifty-eight percent of
                              epidemiologists said NETSS greatly helped them conduct surveillance, while
                              22 percent said it was moderately helpful and the remaining 20 percent
                              said it was minimally helpful. In contrast, 76 percent of laboratory

                              26
                                Twenty-four percent of epidemiologists said NETSS was not very flexible, while 57 percent of
                              laboratory directors said PHLIS had little flexibility. The remaining 28 percent of epidemiologists and
                              16 percent of laboratory directors said the programs were moderately flexible.



                              Page 30                          GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
B-280933




directors said PHLIS was of little help, 13 percent said it was very helpful,
and 11 percent said it was moderately helpful.

Many epidemiologists and laboratory directors thought the system they
use does not share data well with other systems. About two-thirds of the
laboratory directors who use PHLIS and one-quarter of the epidemiologists
who use NETSS said the systems have little to no ability to share data. Many
officials we spoke with complained about a substantial drain on scarce
staff time to enter and reconcile data into multiple systems, such as their
own system plus one or more CDC-developed systems. One large local
health department has one person working full time to enter and reconcile
data for a single disease.

As some of CDC’s disease-specific electronic reporting and information
management systems become outdated and need to be replaced, CDC has
responded to state and local requests for greater integration of reporting
systems and for flexibility in the use of grant funds to build information
systems. In late 1995, CDC established the Health Information and
Surveillance System (HISS) Board to formulate and enact policy for
integrating public health information and surveillance systems.
Subcommittees of the HISS Board bring together federal and state public
health officials to focus on issues such as data standards and coding
schemes, legislation for data security, assessing hardware and software
used by states, and identifying gaps in CDC databases.27 As of August 1998,
the HISS Board or its subcommittees had identified barriers to
implementing effective laboratory reporting standards and some solutions,
established mechanisms to assess information needs and gaps in state and
local data systems, and begun to assess ways to integrate NETSS and PHLIS.

CDC  provides some training and technical assistance related to NETSS and
PHLIS, although state officials we interviewed said such training and
assistance are in short supply. Responses to our survey suggest that CDC’s
training for these two systems was less widely used and less highly valued
than its technical assistance. Nearly all respondents used CDC’s technical
assistance for these two programs, while two-thirds of laboratory directors
and 82 percent of epidemiologists used the training. Almost half of the

27
  Integrating data systems also requires agreement on policy issues, such as access, sharing, and
confidentiality of data. Our work did not address these issues. A recent federal mandate requiring the
use of uniform standards when medical records are shared electronically has begun to intensify efforts
to reach these types of agreements. Section 262 of the Health Insurance Portability and Accountability
Act of 1996 (P.L. 104-191) provided for electronic data exchange standardization for certain
administrative and financial transactions, while protecting the security and confidentiality of
transmitted data. HHS, through its Data Council, is responsible for establishing data and privacy
standards. CDC is a member of the Data Council.



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epidemiologists and 40 percent of the laboratory directors found the
technical assistance highly valuable, but less than 30 percent of either
group found the training highly valuable. Staff at two local health
departments told us that no training was offered to them by state or CDC
staff and the wait for technical assistance could last a month or more.
State and local officials appreciated the help CDC offered but said CDC had
few staff or other resources devoted to helping them use these reporting
systems.

CDC and the states have made progress in developing more efficient
information-sharing systems through one of CDC’s grant programs. The
Information Network for Public Health Officials (INPHO) is designed to
foster communication between public and private partners, make
information more accessible, and allow for rapid and secure exchange of
data. By 1997, 14 states had begun INPHO projects. Some had combined
these funds with other CDC grant moneys to build statewide networks
linking state and local health departments and, in some cases, private
laboratories. In New York, state officials developed a network that will
link all local health agencies with the state health department and over
4,500 health care facilities and diagnostic laboratories. The network
provides electronic mail service and access to surveillance data collected
by the state. In Washington, systems for submitting information
electronically reduced passive reporting time from 35 days to 1 day and
gave local authorities access to health data for analysis.28

In addition to funding specific projects through INPHO grants, in April 1998
CDC adopted a policy that allows states to submit proposals to use disease
grant funds to build integrated information systems. As of November, no
states had submitted proposals, although several indicated they planned to
do so. This initiative involves no new funding but allows states to use
money from existing grants in more flexible ways.

While state officials were supportive of additional CDC efforts in this area,
they also recognized that progress in developing effective networks could
be affected by the actions—or lack of action—of others in the surveillance
network. For example, officials in some states said autonomous local
health departments may elect not to adopt or link with state-developed
systems, thereby continuing some level of fragmentation among data
systems regardless of efforts undertaken by CDC or others.


28
  J. Davies and D. B. Jernigan, “Development and Evaluation of Electronic Laboratory-Based Reporting
for Infectious Diseases Surveillance” (Atlanta, Ga.: International Conference on Emerging Infectious
Diseases, 1998).



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              Public health officials agree that the importance of infectious diseases
Conclusions   surveillance cannot be overemphasized. The nation’s surveillance network
              is considered the first line of defense in detecting and identifying emerging
              infectious diseases and providing essential information for developing and
              assessing prevention and control efforts. Laboratories play an increasingly
              vital role in infectious 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 laboratories. 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
              surveillance 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 integrating 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 surveillance and
              reporting responsibilities.

              The lack of a consensus definition of what constitutes an adequate
              infectious diseases surveillance system may contribute to some of the
              shortcomings in the surveillance network. For example, state public health



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                      B-280933




                      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 local surveillance responsibilities. Moreover, public health officials
                      make decisions about how to spend federal dollars to enhance state
                      surveillance activities without such criteria to evaluate where investments
                      are needed most.


                      To improve the nation’s public health surveillance of infectious diseases
Recommendation to     and help ensure adequate public protection, we recommend that the
the Director of CDC   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 consensus should address such matters as the number
                      and qualifications of laboratory and epidemiologic staff, laboratory and
                      information technology, and CDC’s support of the nation’s infectious
                      diseases surveillance system.


                      CDC officials reviewed a draft of this report. They generally concurred with
Agency Comments       our findings and recommendation and provided technical or clarifying
                      comments, 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 surveillance 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
                      earlier, 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 Director of CDC, the directors of the state epidemiology programs and




                      Page 34                  GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
B-280933




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




Page 35                 GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
Contents



Letter                                                                                                  1


Appendix I                                                                                             38
Objectives, Scope,
and Methodology
Appendix II                                                                                            42
Laboratory Directors’
Survey Results
Appendix III                                                                                           57
Epidemiologists’
Survey Results
Appendix IV                                                                                            73
                        Shiga-Like Toxin-Producing E. Coli, Including E. Coli O157:H7                  73
Six Emerging            Tuberculosis                                                                   74
Infectious Diseases     Pertussis                                                                      75
                        Penicillin-Resistant Streptococcus Pneumoniae                                  76
                        Cryptosporidiosis                                                              77
                        Hepatitis C Virus                                                              78


Appendix V                                                                                             80
Major Contributors to
This Report
Tables                  Table 1: State Public Health Laboratory and Epidemiology Staff                 13
                          Years Per 1 Million Population in Fiscal Year 1997
                        Table 2: NCID’s Grant Assistance for State Infectious Diseases                 21
                          Programs During Fiscal Year 1997
                        Table 3: CDC-Sponsored Regional Laboratory Networks                            22
                        Table I.1: Emerging Infectious Diseases Covered in Our Review                  39


Figures                 Figure 1: State Surveillance of Selected Emerging Infections:                  10
                          Diseases Included, Reporting Requirements, and State Public
                          Health Laboratory Testing




                        Page 36                GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
Contents




Figure 2: Views of State Laboratory Directors and                              24
  Epidemiologists on Extent CDC’s Testing, Consultation, and
  Training Improved Emerging Infectious Diseases Surveillance
  Ability
Figure 3: Views of State Laboratory Directors and                              27
  Epidemiologists on Extent CDC’s Funding Assistance Improved
  Efforts to Use Laboratory Data in Emerging Infectious Diseases
  Surveillance
Figure 4: Views of State Laboratory Directors and                              29
  Epidemiologists on Extent CDC’s Regional Laboratories
  Improved Emerging Infectious Diseases Surveillance Ability




Abbreviations

APHL       Association of Public Health Laboratories
CDC        Centers for Disease Control and Prevention
CSTE       Council of State and Territorial Epidemiologists
EIP        Emerging Infections Program
EIS        Epidemic Intelligence Service
ELC        Epidemiology and Laboratory Capacity Program
HHS        Department of Health and Human Services
HISS       Health Information and Surveillance System
HUS        hemolytic uremic syndrome
INPHO      Information Network for Public Health Officials
NCHSTP     National Center for HIV, Sexually Transmitted Diseases, and
                Tuberculosis Prevention
NCID       National Center for Infectious Diseases
NETSS      National Electronic Telecommunications System for
                Surveillance
PFGE       pulsed field gel electrophoresis
PHLIS      Public Health Laboratory Information System
TTP        thrombotic thromobocytopenic purpura
USDA       U.S. Department of Agriculture


Page 37                GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
Appendix I

Objectives, Scope, and Methodology


                     The Chairman of the Subcommittee on Public Health of the Senate
                     Committee on Health, Education, Labor, and Pensions asked us to study
                     the nation’s public health surveillance of emerging infectious diseases,
                     focusing on the contribution of laboratories. This report discusses (1) the
                     extent to which states conduct public health surveillance and laboratory
                     testing of selected emerging infectious diseases, (2) the problems state
                     public health officials face in gathering and using laboratory-related data
                     in the surveillance of emerging infectious diseases, and (3) the assistance
                     CDC provides to states for laboratory-related surveillance and the extent to
                     which state officials consider it valuable.


Scope of Our Study   Although laboratories are only one part of the surveillance network, they
                     merit attention because newly developed laboratory technology is an
                     increasingly important means to more quickly identify pathogens and the
                     source of outbreaks. We could describe laboratories’ contributions in
                     more detail only by focusing on a small sample of diseases because the
                     specific contribution of laboratory testing to surveillance varies with each
                     disease. Due to the lack of a consensus definition of the types of public
                     health laboratory testing that should occur and the lack of explicit, widely
                     accepted standards to assess epidemiologic capacity, we were not able to
                     assess the overall adequacy of the nation’s emerging infectious diseases
                     surveillance efforts.

                     We selected—with the assistance of officials from CDC, APHL, CSTE, and the
                     American Society for Microbiology—a sample of six bacterial, viral, and
                     parasitic pathogens that can be identified using laboratory tests and pose
                     nationwide health threats (see table I.1). Our sample includes diseases
                     transmitted by food and water as well as ones that had previously been
                     controlled by the use of antibiotics and vaccines. These diseases affected
                     up to 1.5 million people in the United States in 1996 and caused an
                     unknown number of deaths.




                     Page 38                 GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
                                                Appendix I
                                                Objectives, Scope, and Methodology




Table I.1: Emerging Infectious Diseases Covered in Our Review
Disease or pathogen                        Public health threat
Tuberculosis                                    The appearance of strains resistant to one or more commonly used antibiotics threatens
                                                U.S. efforts to control the spread of tuberculosis.
Shiga-like toxin-producing E. coli, including   This deadly—often foodborne—group of E. coli first appeared in 1982. No effective
E. coli O157:H7                                 treatment exists and infection can result in death or long-term disability.
Pertussis (whooping cough)                      Pertussis is one of the nation’s most commonly reported vaccine-preventable childhood
                                                diseases. Incidence is increasing despite high rates of immunization.
Cryptosporidium parvum (Cryptosporidiosis) This parasite is frequently found in the nation’s surface and treated water supplies and
                                           the risks of low-level exposure from its presence are unknown. The disease it causes has
                                           no effective treatment.
Hepatitis C virus                               Identified only in 1988, hepatitis C is a leading cause of chronic liver disease and is the
                                                nation’s most common bloodborne infection. Chronic liver disease related to hepatitis C
                                                is also the most frequent indication for liver transplantation.
Penicillin-resistant Streptococcus              S. pneumoniae, a leading cause of death and illness, is rapidly becoming resistant to
pneumoniae                                      penicillin, with resistance rates as high as 30 percent of cases in some areas.

                                                These six emerging infectious diseases or pathogens are described in more
                                                detail in appendix IV.


Survey Development and                          To gather nationwide data on state public health surveillance efforts for
Distribution                                    the sample of six emerging infections, we surveyed the directors of all
                                                state public health laboratories and infectious diseases epidemiology
                                                programs that report disease-related information directly to CDC. These
                                                include programs in each of the 50 states, the District of Columbia, New
                                                York City, and 5 U.S. territories (American Samoa, the Commonwealth of
                                                the Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands).

                                                To develop questions used in our surveys, we reviewed documentation on
                                                surveillance and emerging infectious diseases prepared by CDC,
                                                professional organizations representing state public health laboratorians
                                                and epidemiologists, professional laboratorians, and public health experts.
                                                We also spoke with officials and representatives from each of these
                                                groups. We worked with officials from professional organizations of public
                                                and private laboratories and CDC to judgmentally select a sample of six
                                                emerging infections with nationwide significance and to identify
                                                appropriate laboratory tests used to generate data for state public health
                                                surveillance efforts.

                                                We pretested our surveys in person with both laboratory directors and
                                                epidemiologists in each of four states and asked knowledgeable people at




                                                Page 39                      GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
                  Appendix I
                  Objectives, Scope, and Methodology




                  CDC and in the laboratory and public health fields to review the
                  instruments. We refined the questionnaire in response to their comments
                  to help ensure that potential respondents could provide the information
                  requested and that our questions were fair, relevant, answerable with
                  readily available information, and relatively free of design flaws that could
                  introduce bias or error into our study results.

                  We mailed 57 questionnaires to laboratory directors in April 1998 and 57
                  questionnaires to epidemiologists in May 1998. We sent at least one
                  follow-up mailing and conducted telephone follow-ups to nonrespondents.
                  We ended data collection in July 1998. At that time, we had received
                  responses from all 57 laboratory directors and from 55 epidemiologists, for
                  response rates of 100 percent and 97 percent, respectively.


Survey Analysis   In preparing for our analysis, we reviewed and edited the completed
                  questionnaires and checked the data for consistency. We tested the
                  validity of the respondents’ answers and comments by comparing them
                  with data we gathered through interviews with public health experts and
                  other public health officials in a total of 30 states and with documentation
                  obtained at CDC and in case study states.

                  We combined responses from epidemiologists and laboratory directors, by
                  state, to analyze for each of our six specific diseases the extent to which
                  state public health laboratories supported state surveillance efforts and
                  the views of epidemiologists and laboratory directors on the adequacy of
                  testing equipment, staff, and the resulting surveillance information. To
                  analyze the extent to which state public health laboratories supported
                  state surveillance efforts, we selected only those states that met the
                  following conditions: for each disease, (1) the state public health
                  laboratory director indicated the laboratory performed tests that
                  generated results used in state surveillance and (2) state epidemiologists
                  indicated that the state conducted surveillance. Using these criteria, we
                  analyzed responses from 54 states.


Case Study Work   We also conducted on-site work at CDC and in three states—New York,
                  Kentucky, and Oregon. These three states were selected as a nonrandom
                  judgmental sample representing diverse geographic areas and public
                  health surveillance programs. In the three states, we interviewed state and
                  local public health officials as well as other interested groups, including
                  representatives from hospitals, large private clinical laboratories, managed



                  Page 40                     GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
Appendix I
Objectives, Scope, and Methodology




care organizations, and medical associations. At CDC, we interviewed
officials responsible for infectious diseases surveillance and laboratories,
information systems development, and support services for states. We
interviewed officials and obtained documentation to determine how these
various programs were organized and how they interacted with other
public health and private parties to obtain, analyze, and share
disease-related data for surveillance. In addition, we reviewed the general
literature on public health surveillance and emerging infectious diseases
and interviewed officials from organizations representing state public
health laboratory directors, state epidemiologists, state and local public
health officials, laboratory professionals, and public health experts.

Our work was conducted from December 1997 through December 1998 in
accordance with generally accepted government auditing standards.




Page 41                     GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
Appendix II

Laboratory Directors’ Survey Results




               Page 42   GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




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Appendix II
Laboratory Directors’ Survey Results




Page 56                     GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
Appendix III

Epidemiologists’ Survey Results




               Page 57   GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
Appendix III
Epidemiologists’ Survey Results




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Appendix III
Epidemiologists’ Survey Results




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Appendix III
Epidemiologists’ Survey Results




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Appendix III
Epidemiologists’ Survey Results




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Appendix III
Epidemiologists’ Survey Results




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Appendix III
Epidemiologists’ Survey Results




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Appendix IV

Six Emerging Infectious Diseases


                           Given the multitude of infectious diseases and varying state surveillance
                           programs, we consulted experts to select a sample of emerging disease
                           threats of nationwide significance. These six conditions are described in
                           greater detail below.



Shiga-Like
Toxin-Producing E.
Coli, Including E. Coli
O157:H7

The Pathogen and Disease   E. coli are normal bacterial inhabitants of the intestines of most animals,
                           including humans, where they suppress the growth of harmful bacteria
                           and synthesize vitamins. For reasons not completely understood, a
                           minority of strains cause illness in humans. Shiga-like toxin-producing E.
                           coli are one of five recognized classes of E. coli that cause gastroenteritis
                           in humans. The group derives its name from producing potent toxins,
                           closely related to those produced by Shigella dysenteriae, which cause
                           severe damage to the lining of the intestine. E. coli O157:H7, first identified
                           as a human pathogen in 1982, causes severe abdominal cramping and
                           diarrhea that can become heavily bloody. Although people usually get well
                           without treatment, the illness can be fatal.

                           E. coli O157:H7 is easily killed by heat used in pasteurization and cooking.
                           However, it can live in acid environments. The amount of bacteria needed
                           to cause illness is thought to be low.


Complications              Three to 5 percent of victims develop hemolytic uremic syndrome (HUS),
                           which is characterized by kidney failure and anemia. Some elderly victims
                           develop thrombotic thromobocytopenic purpura (TTP), consisting of HUS
                           plus fever and neurologic symptoms. Approximately 1 percent of HUS
                           victims die, though many more develop long-term complications. Death
                           rates from TTP can be as high as 50 percent.


Transmission               The disease is often associated with consumption of undercooked ground
                           beef, but sources of contamination are diverse. Recent outbreaks of E. coli
                           O157:H7 have been linked to consumption of contaminated apple juice and




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                           cider, raw vegetables such as lettuce, raw milk, and processed foods such
                           as salami. Illness can also be caused by ingesting contaminated water at
                           recreational sites such as swimming pools or spread from child to child in
                           day care settings.


Costs and Prevalence       For E. coli O157:H7, the estimated annual cost in the United States from
                           the acute and long-term effects of illness and from lost productivity is $302
                           to $726 million, most of which is due to lost productivity. The number of
                           reported cases fluctuates seasonally, peaking in June though September.
                           Northern states report more cases than southern states. In the Pacific
                           Northwest, E. coli O157:H7 may be second only to Salmonella as a cause
                           of bacterial diarrhea. The true prevalence is unknown and the disease has
                           only recently been added to the list of nationally notifiable diseases. CDC
                           received reports of over 2,741 cases from 47 states in 1996.

                           Despite the high visibility of E. coli O157:H7 due to recent outbreaks,
                           clinicians often do not consider it when diagnosing patients or collect
                           appropriate specimens. Although laboratory testing to detect E. coli
                           O157:H7 is relatively straightforward and inexpensive, a recent study
                           showed that at the end of 1994 only about half of the clinical laboratories
                           in the United States were screening stool samples for it.



Tuberculosis

The Pathogen and Disease   Tuberculosis, caused by Mycobacterium tuberculosis, was the leading
                           cause of death from infectious diseases in the United States at the turn of
                           the century; it remained the second leading cause of death until the
                           development of antibiotics in the 1950s. Worldwide, about one-third of all
                           people are infected. Tuberculosis kills over 2.9 million people a
                           year—making it a leading cause of death. Tuberculosis of the lungs
                           destroys lung tissue and, if left untreated, half of victims die within 2 years.
                           The risk of contracting the disease is highest in the first year after
                           infection and then drops sharply, although reactivation can occur years
                           later. Only about 10 percent of healthy people infected with the pathogen
                           develop clinical disease. Tuberculosis is difficult to treat, requiring a
                           6-month regimen of multiple antibiotics to effect a cure and prevent the
                           emergence of antibiotic-resistant strains. When health care is adequate and
                           compliance with treatment is maintained, cure rates should exceed




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                           90 percent, even in those whose immune systems have been compromised
                           by HIV/AIDS.


Complications              The emergence of strains resistant to one or more antibiotics puts not only
                           tuberculosis patients at risk, but also health care workers, social workers,
                           and any other people in frequent contact with them. For cases of
                           multidrug-resistant tuberculosis, fatality rates can exceed 80 percent for
                           immuno-compromised and 50 percent for previously healthy individuals.
                           Multidrug-resistant cases are extraordinarily difficult to treat, and most
                           patients do not respond to therapy.


Transmission               Tuberculosis is spread primarily by the respiratory route from patients
                           with active disease. Shouting, sneezing, and coughing can easily spread the
                           pathogens in the environment. The risk of transmission varies with the
                           length of exposure, degree of crowding and ventilation, virulence of the
                           strain, and health of the person exposed.


Costs and Prevalence       From the 1950s through the early 1980s, the incidence of tuberculosis
                           declined in the United States, then began to increase in 1988, reaching a
                           peak in 1992. The HIV/AIDS epidemic, immigration from countries with high
                           rates of tuberculosis, and outbreaks in facilities such as correctional
                           institutions and nursing homes have contributed to the resurgence.
                           Treatment costs for an individual with multidrug-resistant tuberculosis can
                           be as much as $150,000, 10 times the cost of treating a nonresistant case.
                           In 1996, 54 states reported 21,337 cases to CDC.



Pertussis

The Pathogen and Disease   Pertussis, caused by the bacterium Bordetella pertussis, is characterized
                           by uncontrollable spells of coughing in which one cough follows another
                           too quickly to allow a breath in between. An intake of breath that
                           produces a high-pitched “whooping” sound follows each coughing spell,
                           hence the name whooping cough. The illness lasts about 2 weeks and
                           responds to antibiotic therapy. In the early to mid-1900s, pertussis was a
                           common childhood disease and a leading cause of death among children in




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                           the United States. Today, pertussis is one of the nation’s most commonly
                           reported childhood vaccine-preventable diseases.


Complications              Complications associated with pertussis may be severe, especially among
                           infants. Secondary bacterial pneumonia causes most pertussis-related
                           deaths. Other complications include seizures, encephalopathy, and ear
                           infections. About 1 percent of affected infants died in 1993. The risk of
                           complications is highest among infants and under-vaccinated preschool
                           aged children. In 1994, a strain resistant to the antibiotic preferred for
                           treatment appeared in the United States.


Transmission               Immunity to pertussis can decrease with age. Consequently, young adults
                           and adolescents who contract the disease can be an important source in
                           transmitting it to unimmunized infants. Pertussis among adults and
                           adolescents is often not diagnosed by physicians—despite the presence of
                           a persistent cough—because they do not expect to see the disease in this
                           age group. Pertussis is endemic in the United States.


Incidence                  Pertussis incidence is cyclical, with peaks every 3 to 4 years. Incidence has
                           decreased from 150 cases per 100,000 population prior to 1940 to about 1.2
                           cases per 100,000 by 1991. In 1996, 7,796 cases were reported to CDC, an
                           estimated 10 percent of the true number. Although the total number of
                           reported cases remains well below the annual number reported during the
                           pre-vaccine era, the total number of cases has increased steadily in each
                           peak year since 1977. The reasons for the increase in reported cases are
                           unclear but appear unrelated to decreased vaccination rates or reduced
                           vaccine efficacy. Because few pertussis specimens are tested for
                           resistance, the prevalence of antibiotic-resistant strains is unknown.



Penicillin-Resistant
Streptococcus
Pneumoniae

The Pathogen and Disease   Worldwide, S. pneumoniae infections are among the leading causes of
                           illness and death for young children, individuals with underlying medical
                           conditions, and elderly people. S. pneumoniae is the most common cause



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                           of bacterial pneumonia and is implicated in infections of the ears, sinuses,
                           lungs, abdominal cavity, bloodstream, and tissues that envelop the brain
                           and spinal column. A vaccine that controls the 23 most common strains
                           has been available since the 1980s, but it is largely underutilized. In the
                           past, S. pneumoniae uniformly responded to treatment with penicillin,
                           allowing physicians to treat even severely ill patients without testing for
                           antibiotic resistance. During the 1990s, however, resistance to penicillin
                           spread rapidly in the United States, and strains resistant to multiple
                           antibiotics account for a small, but growing, proportion of cases.


Complications              Case fatality rates—which vary by age, type of infection, and underlying
                           medical condition—can be as high as 40 percent among some high-risk
                           patients, despite appropriate antibiotic therapy.


Transmission               Transmission occurs through contact with infected saliva.

Prevalence                 In the United States, S. pneumoniae causes up to 3,000 cases of
                           meningitis, 135,000 cases of hospitalized pneumonia, and as many as
                           7 million ear infections each year. Resistance to penicillin varies widely by
                           region and age group but accounts for 30 percent of cases in some
                           communities. The prevalence of resistance for most areas of the United
                           States is unknown, possibly because the condition was not nationally
                           reportable until 1996. Limited knowledge of local patterns of resistance
                           and the lack of a rapid diagnostic test often result in therapy that uses
                           either unnecessary or overly broad antibiotics, thereby contributing to the
                           development of resistant strains.



Cryptosporidiosis

The Pathogen and Disease   Cryptosporidiosis, caused by the parasite Cryptosporidium parvum, can
                           affect human intestinal and, rarely, respiratory tracts. The disease has long
                           been known to veterinarians but was first recognized as a human pathogen
                           in 1976. The intestinal disease is generally characterized by severe watery
                           diarrhea and can include abdominal cramps, nausea, vomiting, and
                           low-grade fever. Most healthy individuals recover after 7 to 10 days.
                           Infection of the respiratory tract is associated with coughing and a
                           low-grade fever, often accompanied by severe intestinal distress. Unlike




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                           many bacterial infections, the infective dose of cryptosporidiosis is
                           thought to be small, perhaps as few as 10 organisms, each about half the
                           size of a red blood cell. An infected person or animal can shed millions of
                           organisms per milliliter of feces. Once in the environment, the organisms
                           can remain infective for many months. No safe and effective treatment for
                           cryptosporidiosis has been identified.


Complications              Among persons with weakened immune systems, the disease can lead to
                           dehydration and death.


Transmission               The infectious stage of the parasite is passed in the feces of infected
                           humans and animals. Infection can be transmitted from person to person,
                           from animal to person, through ingesting contaminated food or water, or
                           through contact with fecally contaminated environmental surfaces.


Prevalence                 The parasite is common among herd animals and is present in virtually all
                           the surface—and much of the treated—waters of the United States. The
                           parasite, small enough to slip through most water filters, is resistant to
                           chlorine treatment. The public health risk of contracting the disease from
                           tap water is unknown. Tests on body fluids indicate as many as 80 percent
                           of the United States population have had cryptosporidiosis. Throughout
                           the world, the organism has been found wherever it was sought. In 1996,
                           42 states reported 2,426 cases to CDC.



Hepatitis C Virus

The Pathogen and Disease   The virus that causes hepatitis C was discovered in 1988 and is the major
                           cause of chronic liver disease worldwide. Since 1990, molecular-based
                           laboratory tests have allowed detection of specific antibodies in the blood
                           of infected people. Prior to 1990, diagnosis of hepatitis C was made by
                           excluding both hepatitis A and hepatitis B. The incubation period for acute
                           hepatitis C averages 6 to 7 weeks. Typically, adults and children with acute
                           hepatitis C are either asymptomatic or have a mild clinical illness. More
                           severe symptoms of hepatitis C are similar to those of other types of viral
                           hepatitis and include anorexia, nausea, vomiting, and jaundice. Most
                           patients do not achieve a sustained response to treatment.




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Complications          At least 85 percent of persons infected with hepatitis C develop persistent
                       infection. Chronic disease develops in 60 to 70 percent of infected
                       individuals, and up to 20 percent may develop cirrhosis over a 30-year
                       period. Hepatitis C is a leading cause of chronic liver disease in the United
                       State and a major reason for liver transplants. An estimated 8,000 to 10,000
                       people die annually from hepatitis C and its related chronic disease.


Transmission           Hepatitis C is most efficiently transmitted through large or repeated
                       contact through the skin with infected blood. Intravenous drug use is the
                       most common risk factor for acquiring hepatitis C. Currently,
                       transfusion-associated hepatitis rarely occurs due to donor screening
                       policies instituted at blood banks and to routine testing of blood donors
                       for evidence of infection.


Costs and Prevalence   In the United States, the annual number of newly acquired acute hepatitis
                       C infections has ranged from an estimated 180,000 cases in 1984 to an
                       estimated 28,000 in 1995. The prevalence of hepatitis C in the general
                       population is about 1.8 percent, which corresponds to approximately
                       3.9 million people with chronic infection. Hepatitis C and related chronic
                       diseases cost about $600 million annually (in 1991 dollars).




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Appendix V

Major Contributors to This Report


                  Helene Toiv, Assistant Director, (202) 512-7162
GAO Contacts      Cheryl Williams, Evaluator-in-Charge, (503) 235-8451


                  In addition to those named above, the following individuals made
Staff             important contributions to this report: Linda Bade, Senior Health Policy
Acknowledgments   Analyst; Nila Garces-Osorio, Health Policy Analyst; Julian Klazkin,
                  Attorney; Susan Lawes, Senior Social Science Analyst; and Stan Stenersen,
                  Reports Analyst.




(108351)          Page 80                GAO/HEHS-99-26 Surveillance of Emerging Infectious Diseases
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