oversight

Emerging Infectious Diseases: National Surveillance System Could Be Strengthened

Published by the Government Accountability Office on 1999-02-25.

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

                              United States General Accounting Office

GAO                           Testimony
                              Before the Subcommittee on Public Health, Committee on
                              Health, Education, Labor and Pensions, U.S. Senate




For Release on Delivery
Expected at 9:30 a.m.
Thursday, February 25, 1999
                              EMERGING INFECTIOUS
                              DISEASES

                              National Surveillance
                              System Could Be
                              Strengthened
                              Statement of Bernice Steinhardt, Director
                              Health Services Quality and Public Health Issues
                              Health, Education, and Human Services Division




GAO/T-HEHS-99-62
Emerging Infectious Diseases: National
Surveillance System Could Be Strengthened

              Mr. Chairman and Members of the Subcommittee:

              We are pleased to be here today to discuss our report on public health
              surveillance of emerging infectious diseases, which you are releasing
              today.1 As you know, the spread of infectious diseases, once a problem
              thought to be largely under control, remains a serious public health threat.
              While some diseases are controlled through the use of antibiotics, new
              ones, such as AIDS, are constantly emerging and others, such as
              tuberculosis, re-emerge in drug-resistant forms. Surveillance—the
              monitoring of infections to identify them and their source—is essential to
              public health efforts to control or prevent the spread of infectious
              diseases. Recently, many experts have voiced concerns about the
              adequacy of our nation’s surveillance, particularly for antibiotic-resistant
              diseases.

              In light of these concerns, we examined the nation’s surveillance system,
              with a focus on the role of laboratories. New technology makes
              laboratories increasingly important in identifying pathogens, patterns of
              antibiotic resistance, and sources of outbreaks. In my remarks today, I will
              describe the nation’s surveillance network—which includes public health
              agencies, private health care providers, and laboratories—and the extent
              to which states conduct surveillance and laboratory testing of six
              emerging infections.2 I will also discuss the problems state public health
              officials face in gathering and using laboratory-related data in surveillance
              and the views of state officials on the assistance that the Centers for
              Disease Control and Prevention (CDC) provides for surveillance. For two of
              the six infections we studied—Streptococcus pneumoniae and
              tuberculosis—antibiotic-resistance is a concern. My statements today are
              based on data we gathered through nationwide surveys of state public
              health laboratory directors and epidemiologists3 and from information
              provided by health officials and experts in 30 states and at CDC.4



              1
               Emerging Infectious Diseases: Consensus on Needed Laboratory Capacity Could Strengthen
              Surveillance (GAO/HEHS-99-26, Feb. 5, 1999).
              2
               The six diseases or pathogens we studied are tuberculosis, virulent strains of E. coli that produce
              Shiga-like toxin and include E. coli O157:H7, pertussis (whooping cough), Cryptosporidium parvum,
              hepatitis C virus, and penicillin-resistant Streptococcus pneumoniae.
              3
               Epidemiologists study the causes and distribution of disease or injury in a population.
              4
               Our surveys included programs in all 50 states, 5 territories, the District of Columbia, and New York
              City. Throughout this statement, we refer to this group collectively as “states.” We received responses
              from all 57 laboratory directors and from 55 epidemiologists, for response rates of 100 percent and
              97 percent, respectively.



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             Emerging Infectious Diseases: National
             Surveillance System Could Be Strengthened




             In brief, we found that surveillance of and testing for important emerging
             infectious diseases are not comprehensive in all states. We found that
             most states conduct surveillance of five of the six emerging infections we
             asked about, and state public health laboratories conduct tests to support
             state surveillance of four of the six. However, over half of state
             laboratories do not conduct tests for surveillance of penicillin-resistant S.
             pneumoniae and hepatitis C. Also, most state epidemiologists believe their
             surveillance programs do not sufficiently study antibiotic-resistant and
             other diseases they consider important.

             Many state laboratory directors and epidemiologists reported that
             inadequate staffing and information-sharing problems hinder their ability
             to generate and use laboratory data in their surveillance. However, 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
             for policymakers to assess the adequacy of existing resources or to
             evaluate where investments are needed most. Accordingly, our report
             recommends 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.

             Most state officials said CDC’s testing and consulting services, training, and
             grant funding support are critical to their efforts to detect and respond to
             emerging infections. However, both laboratory directors and
             epidemiologists were 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.


             Emerging infectious diseases pose a growing health threat to people
Background   everywhere. Some emerging infections result from deforestation,
             increased development, and other environmental changes that bring
             people into contact with animals or insects that harbor diseases only
             rarely encountered before. However, others are familiar diseases that have
             developed resistance to the antibiotics that brought them under control
             just a generation ago.



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                              Emerging Infectious Diseases: National
                              Surveillance System Could Be Strengthened




                              Infectious diseases account for considerable health care costs and lost
                              productivity. In this country, about one-fourth of all doctor visits involve
                              infectious diseases. The number of pathogens resistant to one or more
                              previously effective antibiotics is increasing rapidly, reducing treatment
                              options and adding to health care costs.


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

                              The states have principal responsibility for protecting the public’s health
                              and, therefore, take the lead role in surveillance efforts. Each state decides
                              for itself which diseases physicians, hospitals, and others should report to
                              its health department and which information it will then pass on to CDC.
                              Most state surveillance programs include infections from the list of
                              “nationally notifiable” diseases, which the Council of State and Territorial
                              Epidemiologists (CSTE), in consultation with CDC, reviews annually.
                              Nationally notifiable diseases are ones that are important enough for the
                              nation as a whole to routinely report to CDC. However, states are under no
                              obligation to include nationally notifiable diseases in their own
                              surveillance programs, and state reporting to CDC is voluntary.

                              The methods for detecting emerging infections are the same as those used
                              to monitor infectious diseases generally. These methods can be
                              characterized as passive or active. Passive surveillance relies on
                              laboratory and hospital staff, physicians, and other relevant sources to
                              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, health department staff could call clinical laboratories each
                              week to ask if any samples of S. pneumoniae tested positive for resistance
                              to penicillin. 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



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                           Emerging Infectious Diseases: National
                           Surveillance System Could Be Strengthened




                           health care providers, private laboratories, and state and local health
                           departments across the nation. Even when states require reporting of
                           specific diseases, experts acknowledge that the completeness of reporting
                           varies by disease and type of provider.

                           Surveillance usually begins when a person with a reportable disease seeks
                           care and the physician—in an effort to determine the cause of the
                           illness—runs a laboratory test, which could be performed in the
                           physician’s office, a hospital, an independent clinical laboratory, or a
                           public health laboratory. Reports of infectious diseases generated by such
                           tests are often sent first to local health departments, where staff check the
                           reports for completeness, contact health care professionals to obtain
                           missing information or clarify unclear responses, and forward the reports
                           to state health agencies.

                           At the state level, state 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 or 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. CDC also offers an array of
                           scientific and financial support for state infectious diseases surveillance,
                           prevention, and control programs.


Laboratories Play an       Public health and private laboratories are a vital part of the surveillance
Essential Role in          network because only laboratory test results can definitively identify
Surveillance of Emerging   pathogens. In addition, test results are often an essential complement to a
                           physician’s clinical impressions. According to public health officials, the
Infectious Diseases



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Emerging Infectious Diseases: National
Surveillance System Could Be Strengthened




nation’s 158,000 laboratories are consistent sources of passively reported
information for infectious diseases surveillance.5

Every state has at least one state public health laboratory that conducts
testing for routine surveillance or as part of special clinical or
epidemiologic studies. State public health laboratories also 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.

State public health laboratories are increasingly using advanced
technology to identify pathogens at the molecular level. These tests
provide information that can enable epidemiologists to tell whether
individual cases of illness are caused by the same strain of
pathogen—information that is not available from clinical records or other
epidemiologic methods. Public health officials have used advanced
molecular technology to trace the movement of diseases in ways that
would not have been possible 5 years ago. For example, DNA fingerprints
developed by laboratories in a CDC-sponsored network showed that
drug-resistant strains of tuberculosis first found in New York City have
spread to other parts of the country. The fingerprints also showed that
tuberculosis can be transmitted during brief contact among people—an
important discovery that improved treatment and control programs.

CDC  laboratories provide highly specialized tests not always available in
state public health or commercial laboratories and assist states with
testing during outbreaks. Specifically, CDC laboratories help diagnose
life-threatening, unusual, or exotic infectious diseases; confirm public or
private laboratory test results that are difficult to interpret; and conduct
research to improve diagnostic methods.




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.



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                        Emerging Infectious Diseases: National
                        Surveillance System Could Be Strengthened




                        While state surveillance and laboratory testing programs are extensive, not
Not All States          all include every significant emerging infection, leaving gaps in the nation’s
Conduct Surveillance    surveillance network. Our surveys found that almost all states conducted
and Testing for         surveillance of tuberculosis, pertussis, hepatitis C, and virulent strains of
                        E. coli; slightly fewer collected information on cryptosporidiosis. About
Important Emerging      two-thirds collected information on penicillin-resistant S. pneumoniae.
Infections              Similarly, state public health laboratories commonly performed tests to
                        support state surveillance of tuberculosis, pertussis, cryptosporidiosis, and
                        virulent strains of E. coli. However, over half of the laboratories did not
                        test for hepatitis C, and about two-thirds did not test for
                        penicillin-resistant S. pneumoniae.

                        Over three-quarters 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.6

                        Moreover, our surveys found that about half of the state laboratories used
                        a molecular technology called pulsed field gel electrophoreses (PFGE) to
                        support state surveillance of the diseases we asked about. State and CDC
                        officials believe that most, and possibly all, states should have PFGE
                        because it can be used to study many diseases and greatly improves the
                        ability to detect outbreaks.


                        As part of our surveys and field interviews, we asked state officials to
Officials Report That   identify the problems they considered most important in conducting
Staffing Constraints    surveillance of emerging infectious diseases. The problems they cited fell
and Weak Information    principally into two categories: staffing and information sharing.
Sharing Impede          State epidemiologists and laboratory directors told us that staffing
Surveillance of         constraints prevent them from undertaking surveillance and testing for
                        diseases they consider important. Furthermore, laboratory officials noted
Emerging Infections     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 was often either unavailable
                        or inaccessible because of funding or administrative constraints.


                        6
                         One state epidemiologist 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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                        Emerging Infectious Diseases: National
                        Surveillance System Could Be Strengthened




                        We found considerable variability among states in laboratory and
                        epidemiology staffing. During fiscal year 1997, states devoted a median of
                        8 staff years per 1 million population to laboratory testing of infectious
                        diseases, with individual states reporting from 1.3 to 89 staff per 1 million
                        population. The variation in epidemiology staffing was even greater,
                        ranging from 2.1 to 321 in individual states, with a median 14 staff years
                        per 1 million population.


Lack of Equipment and   Epidemiologists and laboratory officials alike said that public health
Cumbersome Systems      departments often lack either basic equipment, such as computers and fax
Hinder Information      machines, or integrated data systems that would allow them to rapidly
                        share surveillance-related information with public and private partners.
Sharing                 For health crises that need an immediate response—as when a serious and
                        highly contagious disease appears in a school or among restaurant
                        staff—rapid sharing of surveillance information is critical. Officials most
                        often attributed the lack of computer equipment and integrated data
                        systems to insufficient funding.

                        Without such equipment, some tasks that could be automated must be
                        done by hand. In some cases, the lack of equipment has required data in
                        electronic form to be reverted to paper 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 it could be reported to local health departments.

                        Our survey responses indicate that state laboratory directors use
                        electronic communications systems much less often than do state
                        epidemiologists. Although most laboratory directors use electronic
                        systems to communicate within their laboratories, they often do not use
                        them to communicate with others. For example, almost 40 percent
                        reported rarely using computerized systems to receive surveillance-related
                        data, and 21 percent used them very little to transmit such data.

                        Even with adequate computer equipment, the difficulty of creating
                        integrated information systems can be formidable. Not only does
                        technology change rapidly, but computerized public health data are stored
                        in thousands of isolated locations, including the record and information
                        systems of public health agencies and health care institutions, individual
                        case files, and data files of surveys and surveillance systems. These
                        independent systems have differing hardware and software structures and




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                            Surveillance System Could Be Strengthened




                            considerable variation in how the data are coded, particularly for
                            laboratory test results.

                            CDC alone operates over 100 data systems to monitor over 200 health
                            events, such as diagnoses of specific infectious diseases. Many of these
                            systems collect data from state surveillance programs. CDC’s patchwork of
                            data systems arose, in part, to meet federal and state needs for more
                            detailed information for particular diseases than was usually reported.

                            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. Further, 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, causing
                            public health investigators to analyze paper printouts by hand.


Public Health Consensus     Although many state officials are concerned about their staffing and
on Core Capacities Needed   technology resources, public health officials have not developed a
to Conduct Surveillance     consensus definition of the minimum capabilities that state and local
                            health departments need to conduct infectious diseases surveillance. For
Does Not Exist              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; and laboratory and information-sharing technology
                            each state should have.

                            CSTE, the Association of Public Health Laboratories, and CDC have begun
                            collaborating to define the staff and equipment components of a national
                            surveillance system for infectious diseases and other conditions. They plan
                            to develop 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



                            Page 8                                                      GAO/T-HEHS-99-62
                             Emerging Infectious Diseases: National
                             Surveillance System Could Be Strengthened




                             data. According to state and federal officials, this consensus would 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. Many state laboratory directors
Wide-Ranging and             and epidemiologists said such assistance has been essential to their ability
Generally Perceived          to conduct infectious diseases surveillance and to take advantage of new
                             laboratory technology; however, a small number of laboratory directors
as Valuable                  and epidemiologists believe CDC’s assistance has not significantly
                             increased their ability to conduct surveillance of emerging infections. Yet
                             many state officials indicated that improvements are needed, particularly
                             in the area of 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. More than half of those responding to our surveys indicated that
                             these three services greatly or significantly improved their state’s ability to
Critical                     conduct surveillance. State officials indicated that CDC’s testing for rare
                             pathogens and the ability to consult with experienced CDC staff are
                             important, particularly for investigating cases of unusual diseases, and that
                             CDC’s training was even more significant for improving their ability to
                             conduct surveillance of emerging infections.

                             Over 70 percent of epidemiologists responding to our survey said that
                             when they need assistance, knowledgeable staff at CDC are easy to locate,
                             but many noted that help with matters involving more than one CDC unit is
                             difficult to obtain. Many state officials said that this problem arose when
                             staff in different units did not communicate well with one another. One
                             official described CDC’s units as separate towers that do not interact. State
                             officials and survey respondents also said they would like CDC to provide
                             more timely test results in non-urgent situations and additional training in
                             new laboratory techniques.


Most Respondents See         Most survey respondents said that NCID’s disease-specific grants and
Substantial Value in Grant   epidemiology and laboratory capacity grants had made great or significant
Assistance Programs          improvements in their ability to conduct surveillance of emerging
                             infectious diseases. For example, after state laboratories began receiving



                             Page 9                                                        GAO/T-HEHS-99-62
                      Emerging Infectious Diseases: National
                      Surveillance System Could Be Strengthened




                      funds from CDC’s tuberculosis grant program—which go to programs in all
                      states and selected localities—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 contrast, only eight states receive CDC funding for active surveillance
                      and testing for penicillin-resistant S. pneumoniae. Where almost all states
                      and most state laboratories reported that they monitor
                      antibiotic-resistance in tuberculosis, far fewer reported monitoring
                      penicillin-resistant S. pneumoniae. Moreover, while all but one state
                      require health care providers to submit tuberculosis reports, fewer than
                      half require reporting of penicillin-resistant S. pneumoniae.


Information-Sharing   Over the past two decades, CDC has developed and made available to states
Systems Need          several general and disease-specific information management and
Improvement           reporting programs. State and federal officials we spoke with said CDC’s
                      systems have limited flexibility for adapting to state program needs—one
                      reason states have developed their own information management systems.
                      Officials told us that two systems used by most laboratory directors and
                      epidemiologists often cannot share data with each other or with other
                      CDC-or state-developed systems. CDC officials responsible for these
                      programs said that the most recent versions can share data more readily
                      with other systems, but the lack of training in how to use the programs
                      and high staff turnover at state agencies may limit the number of state
                      staff able to use the full range of program capabilities.

                      Many state officials 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. The inability to share
                      data between systems also hinders identifying multiple records on one
                      case and undermines efforts to improve reporting by providers.

                      In response to state and local requests for greater integration of systems,
                      CDC established a board to formulate and enact policy for integrating
                      public health information and surveillance systems. The board brings
                      together federal and state public health officials to focus on issues such as
                      data standards and security, assessing hardware and software used by
                      states, and identifying gaps in CDC databases.




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           Emerging Infectious Diseases: National
           Surveillance System Could Be Strengthened




           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). 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. Integrated systems can dramatically improve communication.
           For example, in Washington, electronic information sharing systems
           reduced passive reporting time from 35 days to 1 day and gave local
           authorities access to health data for analysis.7


           Mr. Chairman, this concludes my prepared statement. I will be happy to
           answer any questions you or other members of the Subcommittee may
           have.




           7
            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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