Public Health Laboratories and Health System Change . Federal Government Role in PHL Activities

Various federal government agencies are currently involved, directly or indirectly, in clinical laboratory issues. From direct oversight of the quality of clinical laboratories to coordination of disease reporting efforts, federal agencies play a vital role in the practices of PHLs. At the present time, the CDC and FDA work most closely with PHLs and have established relationships with PHLs. The EPA and U.S. Department of Agriculture (USDA) also have smaller, indirect roles in PHL activities, and the Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS)) (HCFA(now known as CMS)) and the CDC play an important role in maintaining quality standards for all clinical laboratories through the Clinical Laboratory Improvement Amendment of 1988. This section reviews the current role of the federal government in PHL-related issues.

• Centers for Disease Control and Prevention and PHLs

  • Because of the close tie between the PHL core laboratory functions and the disease surveillance and epidemiology functions of the CDC, the greatest potential for collaboration between PHLs and the federal government lies within the CDC. The PHL relationship with the CDC is robust, and one that is important for national disease surveillance.

    The Division of Laboratory Systems (DLS) within the Public Health Practice Program Office (PHPPO) at CDC plays an important role in clinical laboratory issues at the CDC. With 90 FTEs -- laboratory scientists, statisticians, computer specialists, physicians, and administrative support personnel --DLS performs many functions on laboratory-related issues and coordinates many laboratory-related activities within the agency (see Figure 7). For example, DLS officials are represented on a newly formed working group on public health laboratory issues at CDC that serves on an advisory committee to the director of the agency. Other centers at CDC such as the National Center for Infectious Diseases (NCID) are also integrally involved in lab activities (see Figure 7).

    Figure 7: Coordination of Laboratory Activity between CDC Centers and Division of Laboratory Systems
    Name of CDC Center/Office	Lab-Related Functions	Relationship with DLS/Current Activities
    Office of the Director	N/A	There is an advisory panel to the Director of CDC on issues concerning public health labs. Representatives from all CDC Centers, including the Director of PHPPO.
    Office of Managed Care	N/A	This office is still assessing its role in regard to public health labs. A representative from DLS acts as an advisor on public health labs to the Office of Managed Care.
    National Center for Infectious Diseases (NCID)	Conducts lab and epidemiologic research for prevention of emerging diseases (lab-based surveillance) Collects, analyzes, and interprets reports of nationally notifiable infectious diseases and outbreaks submitted by state/local agencies	This center has the directive to write guidelines for diagnosing infectious diseases and consults with DLS on laboratory testing included in those guidelines. In addition, as part of the DLS responsibility for writing and implementing regulatory standards for the Clinical Laboratory Improvement Act, DLS staff consult the NCID on regulations for infectious disease testing.
    National Center for Environmental Health (NCEH)	Develops lab measurements of exposure to toxicants Conducts lab assessment of exposure and disease for health studies of toxicants (lead, mercury, dioxin, pesticides) Provides lab support during environmental health emergencies Provides technical assistance, training, and technology transfer to states	NCEH runs a blood lead program, and consulted DLS on the emergence of new hand-held technologies for field testing of blood lead.
    Epidemiology Program Office (EPO)	Publishes MMWR Coordinates CDC Surveillance Efforts (collects/analyzes data, sends out epidemiologists during outbreaks) Operates a surveillance telecommunication system between CDC and all 50 states	This link is not as close as might be expected. EPO consults DLS when the issue concerns the actual management and running of the laboratories.
    National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)	N/A	This center works jointly with DLS on implementation of the Fertility Clinic Success Rate and Certification Act of 1992. Specifically, DLS is developing and publishing the model certification program, mandated in the law, for embryo laboratories.

    In terms of the types of relationships that have emerged between CDC and PHLs, the CDC's roles in laboratory issues have included: a) laboratory regulation; b) training of PHL personnel; c) disease surveillance; and d) other activities supporting PHLs.

    Laboratory Regulation

    Among DLS's most central responsibilities is implementing and authoring, with HCFA(now known as CMS), the Clinical Laboratory Improvement Amendment (CLIA) regulations. Congress passed CLIA in 1988 to establish baseline quality standards for all clinical laboratories in the United States. HCFA(now known as CMS) has the responsibility for registering laboratories and collecting fees, while CDC has responsibility for technical and scientific issues related to the regulation, such as test categorization, decisions on waivers, and evaluating the impact of the regulations on the public. HCFA(now known as CMS) and CDC share responsibility for authoring and refining the regulatory standards.

    Training of PHL Personnel

    DLS sponsors symposia on best practices in laboratory operations. In 1995, DLS sponsored The Institute on Critical Issues in Health Laboratory Practice. The Institute brought together presentations and discussions on different areas of laboratory practice research:⁷

    • proficiency testing
    • laboratory personnel
    • quality assurance
    • detection of problems affecting patient outcomes
    • establishment of analytical performance goals for the laboratory
    • measurement of the impact of change on laboratory testing
    • laboratory-focused health systems research

    In addition, DLS also has cooperative agreements with ASTPHLD to conduct laboratory training courses on clinical, environmental, and public health laboratory topics. The National Laboratory Training Network (NLTN), a joint venture of ASTPHLD and DLS, provides laboratory training courses in clinical, environmental, and public health topics to laboratory personnel.

    Disease Surveillance

    While exhaustive characterization of CDC disease surveillance activities is beyond the scope of this study, it is important to describe briefly the interplay between PHLs and the CDC on this issue. As the national health agency responsible for disease surveillance / epidemiology and disease prevention, the CDC's mission complements those of the PHLs.

    PHLs play a critical role in national disease surveillance; the emergence of new infectious agents and the re-emergence of infectious disease threats are focusing attention on the need for a strong public health laboratory infrastructure.⁸ PHLs, along with other providers, report the occurrence of notifiable diseases to state and local health agencies. Requirements for reporting diseases are mandated by state laws or regulations, and reportable diseases vary by state.

    The data generated by PHLs are necessary for monitoring disease trends and evaluating the effectiveness of public health interventions. More specifically, data on a number of infectious diseases are aggregated into a national database at the CDC called the National Notifiable Diseases Surveillance System (NNDSS). A list of diseases included in the NNDSS is provided below in Figure 8. The national data from the NNDSS are published weekly in the CDC's Morbidity and Mortality Weekly Report (MMWR). In addition to the NNDSS, other conditions of public health interest are provided by state health departments to the CDC through supplementary surveillance systems.⁹

    Figure 8: Diseases in the National Notifiable Diseases Surveillance System (NNDSS)
    Source: CDC Case Definitions for Public Health Surveillance. MMWR 39(RR-13), October 19, 1990.
    AIDS Amebiasis Anthrax Aseptic meningitis Botulism Brucellosis Chancroid Cholera Congenital rubella syndrome Diphtheria Encephalitis Gonorrhea Granuloma inguinale Hansen's disease	Hepatitis A, B, non-A or B Legionellosis Leptospirosis Lyme disease Lymphogranuloma venereum Malaria Measles Meningococcal infections Mumps Pertussis Plague Poliomyelitis, paralytic Psittacosis Rabies	Rheumatic fever Rocky Mountain spotted fever Rubella Salmonellosis Shigellosis Syphilis Tetanus Toxic shock syndrome Trichinosis Tuberculosis Tularemia Typhoid fever Varicella Yellow fever

    The interchange among providers, PHLs, state health agencies , and the CDC is illustrated in the example of the surveillance system for antimicrobial-resistant pneumococci. Figure 9 below shows an idealized flow of information through a computerized, laboratory-based surveillance system. The physician sends the patient's pneumococcal isolate to the PHL, which then performs susceptibility testing to determine the level of resistance of the isolate to various antibiotics. The susceptibility data are recorded electronically into the laboratory's database, which then transmits this information to the state health agency via an HL7 message. The state health agency communicates the local trends for pneumococci back to the physician and to the CDC. Finally, the CDC communicates the national trends on antibiotic resistance of pneumococci back to the state, physician, and public health community.¹⁰  Efforts to develop such a system are actively being pursued through a collaboration involving the CDC, Council of State and Territorial Epidemiologists (CSTE), and ASTPHLD.

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    Figure 9: Idealized Information Flow in Electronic Disease Surveillance System

    

    Source: MMWR, February 16, 1996, p. 8

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    The CDC is also involved in helping state PHLs respond to disease epidemics and outbreaks. For example, during the 1994 Hantavirus Outbreak in the Four Corners region of the Southwest United States, CDC epidemiologists provided technical expertise in helping the state health agencies determine the cause of the outbreak. In general, the CDC provides as much assistance as the state health agencies request, which can range considerably. For example, during the recent E. coli outbreak in apple juice from California and Washington State, CDC involvement was minimal, while the FDA played a substantial role.

    Other

    In addition to the aforementioned functions, the CDC provides other ancillary support services for PHLs. For example, DLS often serves as a source of technical support for PHLs. In limited instances, the CDC funds PHL programs through grants. For example, the CDC's National Center for Infectious Diseases (NCID) recently provided a grant to the Washington State PHL and Office of Epidemiology to create an innovative system for electronic disease reporting in hopes of lessening the burden of reporting, improving accuracy, and expediting reporting.

• Other Federal Agencies and PHLs

  • Most federal involvement with state PHLs is via the CDC. In addition, several other federal health agencies operate laboratories related to public health.

    FDA, EPA, USDA

    The FDA, the USDA, and the EPA may interact with PHLs on food safety and limited environmental issues.¹¹ In general, the USDA focuses on the safety of raw agricultural products, the EPA focuses on pesticides and associated acute toxicity, and the FDA focuses on finished food products (although they may help USDA with analytics in terms of testing). The interactions among the various players are multiple and complex, with shared communications and memoranda of understanding. Figure 10 depicts the interrelationships among these agencies in food safety functions, the primary area of interchange pertinent to this study.

    Figure 10: Federal Agencies Involved in Food Safety Activities

    

    The various federal agencies' roles during a food-borne disease outbreak offer some additional guidance for understanding their relationships and responsibilities:

    • FDA focuses on collecting food samples, analyzing them, and working with industry to contain the problem within food products (e.g., pulling the product off store shelves).
    • USDA focuses on examining raw agricultural products as a possible source of disease.
    • CDC focuses on epidemiology B consulting with physicians and patients, tracing the source of outbreaks, and working with the FDA to establish links between food products and disease outbreaks where appropriate.

    The FDA has primary oversight responsibilities for food product safety and applied nutrition, and for drugs, devices, biologicals, agricultural products, and veterinary products. Given these roles, the FDA activities bear directly upon PHL functions, and the remainder of this section will discuss relevant FDA activities. However, since the FDA is primarily focused on products and enforcement as opposed to medical/clinical testing, they essentially perform different operations than state PHLs, and the level of interaction with them is minimal. In addition, the FDA's role, by statute, is limited to interstate commerce (i.e., they have no purview over intrastate commerce).

    The FDA and the CDC often provide assistance to state health agencies during food-borne disease outbreaks, especially those that cross state lines. For example, the FDA played a significant role during the recent outbreak of E. coli in Odwalla apple juice in California and Washington. While the Washington and California SHAs initially responded to the outbreak, the FDA used its regulatory authority to pull the apple juice from store shelves, helped locate where shipments of the apple juice had gone, helped the SHAs in the inspection of apple juice plants, and conducted its own microbiologic tests of apple juice samples to test for presence of E. coli. During the outbreak, the CDC's involvement was minor; it coordinated with the Washington State Office of Epidemiology to confirm the number of E. coli related illnesses.

    Most FDA laboratory work is coordinated through field offices with laboratories, and centers around oversight and enforcement. For example, the FDA collects food samples to look for pesticides and pathogens. They also perform some analytical chemistry, often in cooperation with CDC and other agencies, to respond to food-borne disease outbreaks. The FDA also focuses on development of methods for laboratory testing of foods, since it is one of the primary organizations that engages in this activity extensively. Finally, the FDA is currently developing genetic markers and performing analyses that overlaps somewhat with the genetics work of state PHLs. The FDA is performing much less work than it had previously on chemical carcinogens and pesticide residues in food, and now places much more emphasis on more immediate microbiological concerns. In fact, the emphasis of the FDA is currently on acute toxicology, rather than chronic toxicity.

    The FDA has eighteen field laboratories across the country that collect food samples and test them. The main emphasis of the laboratories is on food safety regulation, and the FDA central offices coordinate these activities. In addition, there are some food laboratories in Washington, D.C. that develop methods for food surveillance; and these are disseminated to and used by the field laboratories. The central office focuses more on immediate crises (e.g., outbreaks) and less on routine surveillance of industry. In addition, there are several FDA laboratories that serve as national research centers. For example, there is a large toxicology laboratory in Alabama that concentrates on inspecting seafood from the Gulf of Mexico. The FDA's National Center for Food Technology in Chicago also serves as a major testing development site and focal point for creating and overseeing the Hazard Assessment and Critical Control Points initiative, whereby industry implements quality control measures to ensure food safety. Finally, FDA maintains a primary research site (with no regulatory functions), the National Center for Toxicological Research, in Little Rock, Arkansas.

    In addition to the activities described above, the FDA is involved with the CDC in a special public health program called the Sentinel Sites Initiative. The purpose of the Sentinel Sites Initiative is to obtain improved estimates of presence of food-borne disease agents. The program is being conducted by the CDC with support (both collaboration and funding) and coordination from the FDA and the USDA. The CDC program is coordinated through state PHLs, but county and city laboratories, private laboratories, and FDA field laboratories are also involved.

    Under current surveillance procedures, the CDC collects epidemiologic data on many diseases. The CDC uses estimation techniques to multiply the reported numbers to reflect the likely actual number of cases for a given disease. The Sentinel Sites Initiative aims to improve these estimates by conducting extensive food culturing for four main pathogens (each of which causes similar diarrhea and feverish symptoms):

    • E. coli 0157:H7
    • Salmonella
    • Campylobacter jejuni
    • Listeria monocytogenes

    The culturing, coupled with heightened disease surveillance, is intended to help establish stronger links between the presence of micro-organisms in foods and incidence of food-related illnesses. In turn, these stronger links and better data should allow for more precise estimation of the true incidence of food-borne illnesses, and ultimately the cost of these illnesses to society. The initiative should increase understanding of these diseases and their associated costs, and also help FDA, CDC, and PHLs justify their core functions.

    HCFA(now known as CMS) Role In Public Health Laboratory-Related Issues

    HCFA(now known as CMS) is the agency responsible for the licensing of all clinical laboratories in the United States, with the exception of research laboratories, through the Clinical Laboratory Improvement Amendments, 1988 (CLIA ' 88). Many state PHLs are the licensing entities for CLIA ' 88, thereby assuming responsibility for assuring the quality of clinical lab testing in the state. Two states (WA and OR) have full exemptions from HCFA(now known as CMS) to operate programs accepted as the equivalent of CLIA ' 88. CLIA ' 88 requires laboratories to obtain certification, and to comply with regulations in six broad areas of laboratory operations:

    • proficiency testing
    • personnel
    • inspections
    • patient test management
    • quality control
    • quality assurance

    HCFA(now known as CMS) is responsible for the enforcement of CLIA '88, including the approval of proficiency testing programs, accreditation programs, and state exemption applications for clinical laboratories.¹² In order to comply with CLIA ' 88, clinical laboratories must first register themselves with HCFA(now known as CMS). After registration, HCFA(now known as CMS) surveys the laboratory and determines the laboratory's level of compliance with CLIA ' 88 guidelines. Upon determination of compliance, HCFA(now known as CMS) issues a certificate and collects the appropriate fees from the laboratory. In many instances, clinical laboratories can demonstrate compliance with CLIA ' 88 by using a HCFA(now known as CMS)-approved accreditation organization (e.g., Joint Commission on Accreditation of Healthcare Organizations, College of American Pathologists, Commission on Office Laboratory Accreditation).¹³