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The Role of the Public Health Laboratory and the Definition of Public Health Laboratory Services

Policy Date: 1/1/1996
Policy Number: 9614(PP)

I. Statement of the Problem

There is evidence of a continuing neglect of consideration of the role of the public health laboratory in public health programs and policy. No statement of the need for public health laboratory services appears in certain publications on the future of public health¹ nor in those on public health planning.² Perhaps as a result of this neglect, there have also been concerted assaults on public health laboratories at local, state, and national levels. This neglect and the assaults are due to the considerable lack of understanding of the role of the public health laboratory and the need for public health laboratory services. The Institute of Medicine report Emerging Infections: Microbial Threats to Health in the United States³ specifically states, "Diminishing resources have particularly threatened the state laboratories, which early this century were major contributors to public health microbiology." Decreased funding has reduced the level of services provided by some state and local laboratories. State officials have seen the volume of specimens that public health laboratories examine as a promising source of revenue and have demanded fee-for-service, not recognizing that institution of fee-for-service in lieu of budgeted funds results in a substantial loss of information vitally needed for prevention and control of disease.⁴ Laboratories cannot provide free of charge the tests needed for control of the spread of disease unless those tests are funded with public funds. Public health laboratories function for the benefit of the community and only incidentally benefit any individual patient.
Much disease occurs among the less affluent of the population, those unable to pay for service and who are often uninsured, thus placing public health laboratories in an untenable position, having to provide services to those who need them the most yet cannot pay, while being told to operate on a fee-for-service basis and still maintain the capacity for services to protect the entire population.⁵
In certain cases, it has been possible to institute fee-for-service for certain types of testing, such as neonatal screening and the examination of private water supplies. However, the collection of fees for laboratory services is only appropriate when the fees are not a replacement for budgeted funds needed for overall laboratory operation and when the fees are used for improving the laboratory services, not for other purposes.
Some see privatization of public health laboratories as an answer to the problems of laboratory service. They do not recognize the uniqueness of public health laboratory services and mistakenly equate their services with those of clinical laboratories. They do not recognize the difficulty of providing the same quality and range of expert services in a commercial laboratory setting where profit is the "bottom line."
Dowdle^6,7 defines the testing functions carried out by the public health laboratory, not as "services" but as essential "disease assessment," a key step in prevention and control of disease and necessary for the identification and investigation of outbreaks and the assessment of community illness.
Unfortunately, states and other government agencies have contracted for certain laboratory services traditionally provided by public health laboratories. As health care reform proceeds, the role of public health laboratories in the direct provision of personal health laboratory services to medically and economically indigent populations will be transferred to clinical laboratories through arrangements with managed care organizations.⁸ The clinical laboratory provides "medical care" services, which it does very well, and any laboratory testing that falls into that category may well be privatized. But the clinical laboratory is not prepared to provide "public health" care, to provide, for example, rapid response to epidemics and the laboratory research needed to discover and identify new agents.
It is not satisfactory for a state or locality to contract for the core services, defined as disease assessment, that are required to investigate and control disease outbreaks. Each outbreak is different, requiring differing tests and approaches. Even the development of new methodology may be needed to successfully determine an etiological agent, as was true for Legionnaires' disease. Much of this type of research has been performed in state health department laboratories or in the laboratories of the Centers for Disease Control and Prevention.⁶ Privatization cannot buy the mission of advocacy that is at the heart of the public health laboratory. Private laboratories cannot be expected to perform additional tests and uncompensated investigations because of a concern for the public's health or to fulfill the mission of the public health laboratory. The state's responsibility for the health of its citizens cannot be delegated.⁷
There has been substantial evidence over time that private laboratories have not always provided the accuracy and precision of laboratory testing that would be desired. Proficiency testing programs have often shown that private laboratories have not responded with the desired results.^9-11
There has also been increasing evidence that rather than providing cost-effective services to government, private contracting has helped the private sector to benefit unfairly and at times unscrupulously.¹² It has been supposed that competition in the marketplace would keep costs to government in line, but recently, large national laboratories have become the chief private laboratories in many locales in place of the more numerous smaller laboratories that once existed, so that the climate for monopoly is likely to exist.
A major concern when public health laboratory services are transferred to the private sector is the loss of control. If the public agency is no longer actively involved and has no control over day-to-day operations, the agency no longer has real control over constant quality of product or over compliance with regulations. The public agency may have authority to inspect and regulate, but experience with state supervision of private laboratories shows that it is difficult to enforce regulations and quality assurance. The public agency may, in reality, be unable to enforce the provisions of a contract or to ensure the private laboratory's ability to uphold the terms of a contract. If the private laboratory should have a substantial interruption in service or experience financial difficulties such as bankruptcy, the contracting agency will have grave difficulty in obtaining the missing services, or even find it impossible.¹³
Thus, there is need for a definition of the public health laboratories and its services that can be used to acquaint the public and all aspects of the health care system with core public health laboratory functions.

II. Description of the Public Health Laboratory

The primary function of a public health laboratory is to offer support for public health programs. Its services are directed at the prevention and control of disease and the improvement of the community's health¹⁴ and to offer disease assessments to the epidemiologist and disease control personnel.⁷
Unlike the clinical laboratory, the public health laboratory is concerned with the health of the community and not with that of any individual patient. The core functions of a public health laboratory are distinct in many ways from the functions of a clinical laboratory and may include the following:
1. Examination of specimens for the identification of disease outbreaks, with isolation and identification of a causative agent; determination of the source of infection; identification of carriers; discovery of insect or animal vectors; location of sources of infection in the environment and on fomites. These functions are exemplified in the investigation of infectious disease outbreaks such as Salmonella and Campylobacter food poisonings, staphylococcal toxic shock syndrome, legionellosis, and many mycotic and parasitic diseases. These services require rapid response and interactions with epidemiologists and disease control personnel. They may require research to develop new methodologies for determination of previously unknown or unexpected disease agents.
2. Reference services, including those for identification of rare and unusual microorganisms, such as agents of plague, anthrax, bartonellosis and brucellosis; complicated specification and determination of epidemiological markers of disease agents to define an outbreak, such as E coli 0157:H7 in meat-borne food poisoning; and confirmation testing for screening tests done in other laboratories, as exemplified by HIV (human immunodeficiency virus) testing. The public health laboratory, which will receive specimens from a number of laboratories and has past experience with unusual organisms, can maintain needed reagents, equipment, and expertise in a more cost-effective manner than a clinical laboratory. Clinical laboratories may do screening tests for infectious agents, antigens, or antibodies where instrumentation permits high-volume testing at minimal cost. However, all positive results should be confirmed with more sophisticated and costly tests done at low volume. Without confirmation, false-positive screening tests would go undetected and cause unwarranted suffering, with the results not contributing properly to discovery and control of disease spread. False-negative reports, less easily identified, result in undetected disease and further spread of infection.
3. Testing for diseases of public health importance that are too rare and unusual to be identified by other laboratories, such as rabies, botulism, and drug-resistant tuberculosis. In many areas, only the public health laboratory has the capacity and expertise to provide diagnosis for viral diseases. These are areas of testing of grave importance to the community, yet involve low-volume testing and experienced personnel.
4. Testing for diseases that are prevalent in populations traditionally not willing to approach private medicine and generally unable to pay, such as testing for sexually transmitted diseases, e.g., syphilis, gonorrhea, AIDS (acquired immunodeficiency syndrome), herpes, and chlamydial infections. A major concern in privatization is access to service because this population does not readily seek medical care.
5. Population surveillance studies, such as neonatal screening for metabolic disorders, immune status screening, screening for risk factors, screening for chronic diseases such as diabetes, and blood lead and cholesterol testing.
6. Environmental testing, both microbiological and chemical, for quality of water and air; pollution of large bodies of water; safety of swimming pools and beaches; testing of milk, water, and food for contamination leading to food poisoning; testing of water, soil, and fomites as sources of disease transmission, for example, testing of cooling towers in legionellosis investigations; and testing for cancer-causing agents, for example, pesticides and radiation.
Legislation (HR 2154) has been proposed nationally to require state and federal agencies to use private, for-profit laboratories to perform environmental testing. Although certain environmental testing is already done by private laboratories in some areas, it does not appear cost-effective to close presently well-operated public health laboratories with such expensive equipment and expertise and to transfer their functions to private laboratories. In a situation where testing is just beginning and private laboratories could show they were equipped to handle such testing in a more cost-effective manner than public health laboratories not so equipped, it seems feasible to adopt private testing. However, such a step should require evidence that private testing is cost-effective in comparison with public health laboratory testing. It seems highly improbable that, had all environmental testing been done in private laboratories at the time of the legionellosis outbreaks, the Legionella organisms would have been identified and associated with the outbreaks.
The Environmental Protection Agency (EPA) has described those factors that make it difficult, if not impossible, for it to carry out its mandated functions when using private laboratory services. It was stated that contract laboratories not assured of continued contracts and without other revenue would be unable to maintain the equipment and expertise needed over time. EPA laboratories carry out research to develop new, less costly methodologies and develop innovative technologies for use in the field. Contracting would not permit the use of these newer, less costly techniques and would preclude their development. Industrial security is also a concern, since EPA collects and analyses process wastes generated by manufacturers, who do not want to risk the results falling into the hands of competitors. To be objective and credible, enforcement of environmental regulations cannot be dependent upon contractors. It appears there are no data to show that privatization of environmental testing is any more cost-effective and productive than privatization of other laboratory services.
7. Research aimed at the discovery of new and emerging pathogens in what is or may become an outbreak situation; research aimed at improvement of chronic disease testing; and research directed toward development of new methodology to meet newly developing situations.
8. Centralization of data for rapid transmission to epidemiologists, infectious disease specialists, and other decision makers. The public health laboratory is a center where information from all types of laboratories is collected, analyzed, and transmitted.
9. Training of personnel in clinical and other laboratories; regulation, certification, and licensing of laboratories are all means by which the public health laboratory protects the health of the public by setting standards for laboratory testing and training technical personnel.
These core services serve to protect the public from the spread of infectious diseases, to identify disease conditions early for appropriate treatment to prevent spread, and to identify populations at increased risk of acute and chronic illnesses. They provide a cost-effective public health function.¹⁴
The US government has determined that $9 in medical treatment is saved for every $1 spent in newborn screening for metabolic disorders, resulting in a savings of $36 million annually. In 1992, 8,589 animals were confirmed as rabid among some 80,000 tested, so that over 71,000 persons were spared the cost of rabies prophylaxis, a savings of over $100 million yearly. In 1 year, public health laboratories found 108,000 positive chlamydial tests. It has been estimated that detection and treatment of these cases yielded annual savings of $100 million to 400 million over the cost of later treatment.¹⁴ These are only three among many examples of the savings associated with disease prevention assisted by laboratory findings.
There may also be a diversity of other laboratory services offered at local and state levels depending upon the problems in various locales and the extent of the availability of other needed laboratory services.

III. Future of the Public Health Laboratory

The history of the emergence of newly discovered pathogens and of previously undetected infectious diseases makes clear the need for expert investigative laboratory services with identification of unusual organisms. It seems obvious that public health laboratory services are essential for this purpose and for the proper functioning of many other public health programs. There will surely be a continuing need for core functions and for the expertise of personnel trained in public health laboratory work.¹⁶
Private laboratories cannot be expected to provide equivalent services. Even if it were possible to transfer the sophisticated equipment required, it would be very difficult to transfer the expertise and hardly cost-effective to provide the type of physical structure needed for safety in working with dangerous disease organisms, such as certain viruses and rare bacteria.
Although much has been said about it, there is at present no hard scientific evidence to establish that privatization provides an equivalent quality and quantity of testing at less cost than can be provided by the public health laboratory. Without data to prove cost-effectiveness and equivalence of quality, it is difficult to see the logic of an argument that an agency operated for profit, and totally dependent upon the production of profit, will be able to provide service at less cost than a public organization not there for profit. If a public health laboratory is not being operated in an efficient and effective manner, that situation can and should be corrected. However, it should be a given that the core functions of a public health laboratory that provide disease assessment data are the responsibility of the community served and should be funded by that community.
Whatever the future for delivery of health care in this country, interactions of public health laboratories with hospital and clinical laboratories that see patients, collect specimens, and do initial isolations will continue to be as essential as they have been in the past. These laboratories should function as partners, so that centralization of the data that all laboratories provide can assist disease control activities. McDade (unpublished manuscript, 1996)¹⁷ recommends the establishment of public health institutes to provide a forum where public and private sectors can develop better mechanisms to ensure effective strategic planning and resource allocation for laboratory-based programs, especially in areas of shared responsibility.
The health care system in general has become more and more cognizant of the value of prevention. Since public health laboratory services are a key factor in many prevention programs, all facets of the health care system need to recognize the place of the public health laboratory in health care. As emphasis on prevention increases, so will the need for preventive services. It is not possible to know what research will bring to the health care system and to disease prevention in the future, so it is also not possible to predict the services that public health laboratories will need to provide. Research in methodology and training of personnel will need to be maintained to equip these laboratories to meet these challenges.
If public health laboratories are to continue to fulfill their role as providers of disease assessment data, they must acquire and maintain the capacity to respond to outbreaks of exotic organisms, since geographic boundaries in disease spread no longer exist. They need to improve their ability for rapid electronic transfer of information both locally and nationwide. As the health care system changes, they must be prepared to extend their partnerships with private laboratories, quickly gain input from them of initial information on cases of disease, and share analyzed data with them.
Only if adequate funding is provided will public health laboratories be able to provide these functions. Those who believe in the role of disease assessment and disease prevention need to advocate for the place of the public health laboratory in the public health structure.

IV. Recommended APHA Actions

Therefore, the APHA should:
1. Recognize the role of the public health laboratory and the need for public health laboratory disease assessments; express support for public health laboratories wherever and whenever possible.
2. Encourage the delineation of the public health laboratory services required for projects and program in planning documents, programmatic budgets, grant proposals, and documents on the future of public health and health care delivery, such as a further edition of Healthy Communities 2000: Model Standards2 and similar publications.
3. Advocate for public health laboratories when they are under assault at national, state, and local levels by: (1) opposing fee-for-service as the sole or primary means of funding for public health laboratory services in accord with APHA's Resolution 8406: Public Health Laboratory Funding;"^4,11 (2) opposing decreases in funding for national and state public health laboratories that would result in such a reduction of service that core functions could no longer adequately support public health programs; and (3) expressing these oppositions and Association support for public health laboratories in testimony to federal and state legislatures.
4. Advocate for funding for the Centers for Disease Control and Prevention's laboratory functions in federal budgets.
5. Advocate and facilitate public health institutes or other arrangements that would bring together public and private sector laboratory representatives to plan and coordinate laboratory programs in areas of shared responsibility.
6. Request that state/local public health affiliates advocate for funding for state and local public health laboratories in state, county, and city budgets and assist the affiliates in so doing.
7. Request that each state/local public health affiliate adopt in its state/city assembly a position paper similar to this one in defense of public health laboratories.

References

1. Institute of Medicine. The Future of Public Health. Washington, DC: National Academy Press; 1988.


2. Healthy Communities 2000: Model Standards. 3rd ed. Washington, DC: American Public Health Association; 1991.


3. Institute of Medicine. Emerging Infections, Microbial Threats to Health in the United States. Lederberg J, Shope RE, Oaks, SC, eds. Washington, DC: National Academy Press, 1992.


4. American Public Health Association. Resolution No. 8406: Public Health Laboratory Funding. APHA Public Policy Statements, 1948 to Present, Cumulative. Washington, DC: American Public Health Association, current volume.


5. Skeels MR. Public health laboratories build healthy communities. Lab Med. 1995;26:588-592.


6. Dowdle WR. The public health laboratory in the decade of the 90's. Newsletter. Association of State and Territorial Public Health Laboratory Directors; Summer 1990.


7. Dowdle WR. The future of the public health laboratory. Annu Rev Public Health. 1993;14:649-694.


8. Baker EL, Melton RJ, Stange PV, et al. Health reform and the health of the public. JAMA. 1994;272:1276-1282.


9. Centers for Disease Control and Prevention. Clinical laboratory performances on proficiency testing samples-United States, 1994. MMWR. 1996;45:193-194.


10. Health officials dismayed at plan to privatize state lab. The Inquirer, March 21, 1996;Neighbors:3.


11. Mills WA, Besser-Wiek JM, Osterholm MT, MacDonald KL. Statewide survey of laboratories performing Mycobacterium tuberculosis testing in Minnesota. Public Health Rep. 1996;111:152-156.


12. Orthoefer JE, Empereur RW, Bacon JM. Privatization in the public sector: lessons for local health departments. Curr Issues Public Health. 1995;1:186-190.


13. State Capacity Task Force. The use of fee-based programs. Minute Attachments. Association State Territorial Public Health Laboratory Directors, March 19, 1996.


14. US Environmental Protection Agency. Comments on HR 2154. To privatize environmental testing analysis, and for other purposes. The ASTPHLD Minute Attachments. Association State Territorial Public Health Laboratory Directors, March 1996.


15. Cordts JR. The laboratory as a model public health function. In: Public Health Laboratories' Role. Washington, DC: Association of State and Territorial Public Health Laboratory Directors; 1995;1-7.


16. Satcher D. Statement before the Labor-HHS Appropriations Subcommittee. US House of Representatives, 1996; May 1:10.

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