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Core Functions and Capabilities of State Public Health Laboratories
A Report of the Association of Public Health Laboratories
The material in this report originated in the Public Health Practice Program Office, Edward L. Baker, M.D., Director, and the Division of Laboratory Systems, Robert Martin, Dr.P.H., Director.
Emerging natural and man-made threats to the health of the nation's population require development of a seamless laboratory network to address preventable health risks; this can be achieved only by defining the role of public health laboratories in public and private laboratory service delivery. Establishing defined core functions and capabilities for state public health laboratories will provide a basis for assessing and improving quality laboratory activities. Defining public health laboratory functions in support of public health programs is the beginning of the process of developing performance standards for laboratories, against which state public health laboratories, and eventually local public health and clinical laboratories, will establish and implement best laboratory practices. Public health is changing, and as a part of that change, public health laboratories must advocate for and implement improvements for public health testing and surveillance. These changes are outlined also in the Association of Public Health Laboratories consensus report (Association of Public Health Laboratories. Core functions and capabilities of state public health laboratories: a white paper for use in understanding the role and value of public health laboratories in protecting our nation's health. Washington, DC: Association of Public Health Laboratories, 2000).
Delivery of high-quality laboratory services is essential in our health-care system both for providing the foundation for clinical decisions and as an objective means to measure and monitor biological and environmental markers. In response to an increasing concern regarding the U.S. population's vulnerability to health risks, efforts have been made to reduce preventable risks (e.g., those related to terrorist events, antimicrobial resistance, foodborne illness, and environmental threats). Accurate and timely laboratory analyses are critical to identifying, tracking, and limiting public health threats and ultimately reducing rates of preventable morbidity and mortality (1--3). Optimal functioning of the public health system to meet these threats is dependent on uniform and high-quality laboratory testing (4). Furthermore, facing public health challenges from emerging and reemerging pathogens (e.g., West Nile virus , drug-resistant communicable disease agents , and Escherichia coli O157:H7 [7,8]), requires evaluation of the functions, responsibilities, and capacities of state public health laboratories (SPHLs) (9). This evaluation of the role of public health laboratories includes environmental threat concerns (10) and appropriate application of technological advances (i.e., tandem mass spectrometry or pulsed field gel electrophoresis [11--13]). Certain disease prevention and control programs within CDC support and promote technical capacity in SPHLs (e.g., PulseNet for molecular typing; Laboratory Response Network for bioterrorism preparedness; Epidemiology and Laboratory Capacity program; and resources for tuberculosis, human immunodeficiency virus [HIV], sexually transmitted diseases, blood lead, and others).
A key precept for public health is recognizing that the majority of testing for public health is either performed in private laboratories or is dependent on private laboratories for referral and reporting. Therefore, a function of public health, and specifically of SPHLs, is to ensure the availability, quality, and reporting of laboratory testing performed in the private sector. A minimal association exists between SPHLs and private (i.e., hospital and independent) laboratories, and this limited association can lead to a lack of communication and coordination of the laboratory testing that is necessary to support public health interventions.
An impediment to improving public-private coordination is the disparity of functions among SPHLs, because those functions evolved differently in each state. As of January 2002, approximately 174,000 laboratories were operating in the United States; this number included an estimated 2,000 public health laboratories, and the remainder included hospital, independent, and physician office laboratories (14). Laboratories are difficult to quantify or describe according to the volume and scope of work they perform. SPHLs operate autonomously, and delivery of public health testing historically has been, and will continue to be, state-based. State health systems vary in aspects that affect the delivery of quality public health testing. For example, state health systems individually determine which diseases are reportable by laboratories or clinicians (15). Technical standards exist for disease-specific testing, but no standard definitions exist for the broader role and functions of public health laboratories. Developing an effective laboratory system for public health testing requires definitions for standard functions of SPHLs, including a broader role in ensuring the quality of testing throughout the state.
Since the 1980s, the HIV epidemic has emphasized SHPLs' critical roles of assessing, leading, and developing health policy. Public health laboratories still consist of diverse groups and institutions (9). Public health laboratories are a loose network of federal, state, and local laboratories that work in undefined collaboration with private clinical laboratories (16). Disease outbreaks during 1992--2002 have increased the recognition of the specific testing capacities in SPHLs and reinforced the need for improving and developing communication and coordination of testing services between SPHLs and clinical laboratories (17--20). After the anthrax attacks during September--October 2001, agencies within the U.S. Department of Health and Human Services, including CDC, established laboratory priorities for bioterrorism preparedness. These priorities encourage leadership functions for policy development, laboratory improvement, and training and education for clinical laboratory personnel. Guidelines accompanying the FY 2002 supplemental emergency funding for bioterrorism preparedness and response and public health infrastructure improvement address the need for public-private integration of laboratory functions critical to public health. The need to develop these links is well-recognized and is the single critical benchmark for laboratories in the Guidance for Fiscal Year 2002 Supplemental Funds for Bioterrorism (21). That benchmark requires developing a plan to improve working relationships and communication between clinical laboratories and higher lever laboratories to ensure that core capabilities are maintained. Core capabilities concerning bioterrorism include 1) performing rule-out testing on critical bioterrorism agents; 2) safely packing and handling specimens; and 3) referring specimens and isolates to higher level laboratories for further testing.
The trend to better define the role of public health is apparent in public health policy documents (e.g., the Essential Services ). The first of the 10 essential services of public health (i.e., monitoring health status to identify and solve community health problems) is directly dependent on laboratory provision of analysis, pathogen identification, and disease monitoring. The second essential service (i.e., diagnosing and investigating health problems and health hazards in the community) is directly supported by laboratory functions (22). The significance of the Association of Public Health Laboratories (APHL) core functions and capabilities of SPHLs lies in the fact that laboratory testing is a common denominator for fulfillment of these and the majority of public health objectives, which are designed to be met by measurable indicators of goals. Attainment of these goals can only be accomplished through performance of consistent, high-quality laboratory testing, for which assessment requires a definition of laboratory capabilities.
Healthy People 2010, which also shapes the role of public health, addresses goals for building the public health infrastructure (23). Included among the goals are increasing accessibility of laboratory services and the proportion of tribal, state, and local health agencies that provide or ensure comprehensive laboratory services to support essential public health services (Objective 23-13) (23). The definition of critical laboratory services and its functions are described by APHL (24), and consensus regarding these functions of public health laboratory services is the base for assessing all laboratories. APHL's recommendations go beyond the traditional functions that are acknowledged as the responsibilities of laboratory services (i.e., specimen analysis and isolate identification, disease control and surveillance, reference and specialized testing, and food safety) to areas of leadership and strengthening laboratory infrastructure for the public health testing system (i.e., laboratory improvement and regulation, policy development, training and education, and partnership and coordination). These recommendations for core functions enable state leaders and stakeholders (e.g., state epidemiologists, state and local health officers, and state legislators) to assess the adequacy of the public health laboratory systems, allocate resources, and encourage needed relationships between the public health system and the health-care delivery system. Further, these recommendations provide a guide for assessing and monitoring the service and value of the public health laboratories by serving as a basis for creation of policy development (25). From this foundation, development of laboratory performance standards and laboratory quality assurance can evolve in the United States.
Development of the core functions document and this report represent the culmination of activities that reflect a 1988 Institute of Medicine (IOM) report (25). The IOM report stated, "public health, as a profession, as a governmental activity, and as a commitment of society is neither clearly defined, adequately supported, nor fully understood" (25). Since the early 1990s, a common theme of all public health reports has been that public health activities and practices were not well-defined and that the mission and infrastructure necessary to support public health was also not well-defined (26). In this report, we focus on one component (the state public health laboratories) of one critical piece of the public health infrastructure (laboratories) and relate the consensus view of the membership of APHL regarding the core functions and capabilities of SPHLs.
Although state public health laboratories have been in existence for longer than 100 years, no organization had yet defined necessary activities of SPHLs. However, the lack of defined activities is understandable, considering that this group of >50 laboratories was created independently by states and from the outset had different charters that gave them a heterogeneous character. Despite their diversity, in the aggregate, they represent a critical component of our nation's public health infrastructure, and public health is well-served to have a defined list of core functions and capabilities that all state public health laboratories have endorsed.
This attempt to define the core functions of SPHLs began in approximately 1993 when APHL (then the Association of State and Territorial Public Health Laboratory Directors) developed an internal unpublished report that addressed the need to distinguish public health laboratories from other laboratories (e.g., those in clinical and hospital settings) (G. Anderson, A. DiSalvo, and W. Hausler in "Task Force Report on the Public Health Laboratory: A Critical National Resource; Report to the Association of State and Territorial Public Health Laboratory Directors," unpublished, 1993). In 1993, a perspective regarding the evolution of public health laboratories since their creation was published (27).
APHL continued to review the need for a more formal definition of core functions for public health laboratories, and in 1995, an internal report (R. L. Cada, S. L. Inhorn, P. Bouchard, J. M. Counts, and M. W. Kimberly in "Core Functions of Public Health Laboratories: A Report to the Association of State and Territorial Public Health Laboratory Directors by a Task Force, unpublished, 1995) was distributed to the membership. The report started the process of more clearly identifying the core functions of SPHLs and related the core functions of laboratories to assessment, quality assurance, and policy development --- the core functions of public health established in the 1988 IOM report (25). In 1996, professionals within the laboratory section of the American Public Health Association issued an internal report on the role of public health laboratories. In 1999, health officials stated that the United States needed a national laboratory system (17,19,20), and the General Accounting Office stated, "public health officials have not developed a consensus definition of the minimum capabilities that state and local health departments need to conduct infectious disease surveillance" (28). By that time, APHL had already charged its Leadership Development Task Force with developing a definitive statement concerning the core functions of state public health laboratories. APHL's resulting strategic plan reflected the priority needs and activities of APHL and guided their mission in defining the role of SPHLs in two of their strategic goals for 1999--2001: 1) to ensure that essential laboratory services are available to support public health activities in the changing health-care environment, and 2) to advocate effectively for public health laboratories through legislation, policy development, and public information (29).
The work of the APHL Task Force in defining core functions and capabilities of SPHLs was performed in collaboration with and support from CDC's Public Health Practice Program Office, Division of Laboratory Systems (PHPPO/DLS). Since 1987, APHL has had a cooperative agreement with CDC through PHPPO/DLS. A component of this agreement has focused on the National Laboratory Partnership (NLP), which is a multifaceted program that allows collaboration among APHL members, professional and scientific staff, and CDC for work related to public health laboratory practice. NLP activities with CDC have supported APHL's development of this report. Representatives from PHPPO/DLS actively participated in APHL meetings and discussions that led to the consensus vote regarding the APHL position. The value of defining core functions for SPHLs lies in the support given to CDC initiatives for developing laboratory infrastructure for testing (e.g., foodborne disease investigations and vaccine-preventable diseases). PHPPO also views the core function report as a prerequisite to developing performance standards for public health laboratories. The report (24) was adopted in its entirety by unanimous vote as the consensus position of APHL at the 2000 APHL annual meeting. Those adopted core functions are stated in this report.
These recommendations describe the broader functions and elements that are necessary to ensure the laboratory capability to execute the core functions. The term core function is a role assumed by the laboratory that underlies the laboratory's ability to support public health. The term capability denotes a specific activity that ensures the successful implementation of an associated function. For each capability, each state public health laboratory has a capacity for performing a specified number of tests within a certain time. Laboratory capacity is a key concern in light of strengthening bioterrorism preparedness and the federal mandate to address infectious disease outbreaks, other public health threats, and emergencies (24).
This report is the beginning of a process to improve public health testing, which will also require the definition of core functions of public health laboratories at the local level. This will help meet the need identified in the 1988 IOM report to better define and understand one of the critical infrastructure components of public health.
SPHL Core Functions
SPHLs should accomplish the following 11 core functions as part of their organizational capacity:
Disease Prevention, Control, and Surveillance
Integrated Data Management
Reference and Specialized Testing
Environmental Health and Protection
Laboratory Improvement and Regulation
Public Health-Related Research
Training and Education
Partnerships and Communication
Before development of the APHL Core Functions and Capabilities of State Public Health Laboratories (24), a concise and thorough definition of public health laboratory functions in support of public health programs did not exist. Typically, public health laboratories had been recognized only for the service they provided in analyzing specimens, both human and environmental, and for identification and confirmation of microorganisms. Funding was available for these visible functions of the laboratory, but recognition and noncategorical funding was not available for functions related to infrastructure, including training and workforce development; communication among laboratories, medical colleagues, and the public; and leadership for laboratory personnel. Certain external activities directly related to the analysis function have not been recognized (e.g., transport of isolates and specimens to referral laboratories --- the cost and logistics have been left to the individual laboratories, both public and private, to work out on their own [state-supported laboratory transport systems exist in only a limited number of states]).
The APHL core functions and this report are advancements in understanding the unique roles and activities provided by public health laboratories in the United States. Other national public health activities --- including bioterrorism preparedness --- will benefit from recognition of these roles and functions. The timing of efforts that are the logical outgrowth of the core functions is critical during this period of strengthening public health infrastructure and preparedness for bioterrorist events and other public health emergencies. The definition of laboratory core functions will provide a basis for assessment and improvement of laboratory activities, followed by policy development and quality assurance.
The National Laboratory System, a cooperative initiative of CDC and APHL, is dependent on and supportive of the laboratory core functions, including those external functions that integrate with clinical laboratories. The National Laboratory System is a strategic priority for APHL and includes the objectives of assessing and monitoring private and public laboratory capacities, increasing coordination and communication among laboratories, and building partnerships between public and private laboratories, workforce development through training and education, and promotion of laboratory standards. As federal guidelines have emphasized the need for effective working relationships and communication between clinical laboratories and higher-level laboratories, pilot projects in four states have demonstrated the benefits of systematic integration of laboratories, with attention toward upgrading laboratory function.
Another key continuation of the definition of laboratory core functions is the need to develop performance standards. Performance standards are critical for public health in providing potential benefits of improved accountability; better resource deployment; enhanced capacity building for community, state, and national public health systems; widespread use of best practices; and increased focus on mission and goals (30). The same premise is true for benefits of performance standards for laboratories. Work is in progress to create performance standards for the nation's laboratories through collaborative efforts of APHL and CDC.
The outcome from the definitions within the APHL 2000 Consensus White Paper on the Core Functions and Capabilities of State Public Health Laboratories will extend through the following needed initiatives:
Collectively, these efforts will enable all laboratories in the United States to actively support and participate in major public health activities that keep the population healthy and free of disease and unhealthy environmental exposures.
The preparers of this report are grateful for the contributions of Jon Counts, Dr.P.H., University of Washington, Seattle, Washington; Roger Carlson, Ph.D., Pennsylvania Department of Environmental Protection, Harrisburg, Pennsylvania; Jack DeBoy, Dr.P.H., State Department of Health and Mental Hygiene, Baltimore, Maryland; Leonard Green, M.P.S., Gregory Hayes, Dr.P.H., and Ray Lundgren, Jr., Ph.D., retired, Providence, Rhode Island; and Steve Hinrichs, M.D., University of Nebraska Medical Center, Omaha, Nebraska.
* This report was supported in part by an appointment to the Research Participation Program at CDC, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Department of Health and Human Services, CDC.
Not listed in order of priority or significance.
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