Changes in health markets and the environment faced by PHLs naturally raise the questions of whether the core functions of laboratories must change in response or whether more leadership from the laboratories can improve public health. Our study suggests that while the overall charge of PHLs (involvement in assessment, assurance, and policy development) remains constant, many of the tactics used to achieve these goals must change in the context of health system and technological innovation.
A central concern of both state and federal actors is the definition of core PHL functions and activities. This subject has been closely studied over the years by the Association of State and Territorial Lab Directors (ASTPHLD) and by a number of PHL directors. The function of PHLs varies dramatically from state to state. The notion of a core set of activities is particularly charged, because it defines, in part, the appropriate role of the PHL. There is a heated debate over what laboratory services belong in the public sector: PHL directors typically maintain that states can often provide services less expensively and of a higher quality because there is no profit motive, whereas commercial laboratories typically maintain the opposite position. Anecdotal evidence is available to support either side of this debate.
There are some services that most agree belong in the public domain. These services typically include tests that are not commercially viable as well as those that are critical to ensuring that emerging infections are identified. Still, PHL viability in generating revenues is a central issue in defining core PHL functions. Public health officials are split on this issue between those who believe that PHLs need to show value, and those who believe that user fees establish a perverse relationship with the private sector and may discourage indigent patients from seeking services. Another fundamental issue is whether direct patient care testing is a core function. Again, the debate centers on whether the state should be engaged in de facto competition with the private sector.
Most neutral observers agree that assurance remains a critical function for PHLs. While regulators will never be popular with industry, assuring the quality and consistency of testing is a core public function, particularly in the area of infectious diseases. However, assurance needs to be updated relative to information technology; private sector stakeholders expressed strong and legitimate concerns about the cumbersome nature of regulatory intervention in most states.
Policy development also needs to change in response to changes in the health care system. The notion of public-private partnerships has come into vogue and, as has been shown in Washington State, can be used proactively by states to help shape the delivery system. Policy development in laboratories also needs to come to terms with the growth of managed care, which is an important policy goal in most states. The Michigan experience demonstrates that states can use managed care contracting to forge a stronger safety net.
Federal leadership is needed in a number of areas to support development of the nation's laboratory infrastructure and to help the PHLs redefine and solidify their substantive roles in each of the three core PHL activities. The fragmentation of the PHLs' mission is reflected at the federal level – the CDC has the most active involvement with state PHLs yet there is no single and clear locus of responsibility for PHL activities within the CDC nor elsewhere in DHHS. As noted above, there is no unified, common theme among PHL strategic plans, and centralized leadership is likely a necessary (but not sufficient) condition for a common purpose to be realized. Increased federal guidance could be particularly useful in assessing the regionalization of some laboratory services, in supporting information infrastructure development, and in facilitating communication between public and private concerns.